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Who is this GMP everyone is so afraid of?

Quality management

23 August 2023

The inspiration for writing this article comes from a situation in the professional life of a CSV Specialist in a large pharmaceutical company. The quote placed in the title of this post, “Who is this GMP everyone is so afraid of?” was uttered during one of the project meetings. I should mention that the author was one of the key individuals who influenced the implementation process. What did I think in the first moment? That this person has very limited understanding not only of the details of quality processes—after all, that’s what the designated specialists assigned to the project are for—but also lacks knowledge about the specifics of the industry in which they work. This specificity requires an understanding of how important and necessary it is to act in accordance with legal guidelines and quality processes implemented within the company.

Why is validation and quality, in general, considered a black art by many? In my opinion, the law, including pharmaceutical law, is intricate and often leaves room for interpretation. Moreover, there is a belief, not entirely clear to me , that complying with these legal requirements is difficult and tedious. As a result, the thought emerged in my mind to try and demystify quality and regulations in the IT environment, even if only to a small extent. Together with my invaluable colleagues from the TTMS Quality Team Leaders [Karolina Grzywacz, Marcin Kraska, Marika Juskowiak, Krystian Stempniak, Patryk Duraj], we will attempt to lift the “difficulty” curse from working in a regulated environment and will write a series of short articles for this purpose. For example, we will explain what the acronym GMP stands for and what GMP actually means.

Origin and Evolution of GMP
Adapting GMP for the IT Industry
Ensuring Quality, What is GMP?
Risk Mitigation
Compliance and Auditability
Customer Trust
Key Elements of GMP Regulations in IT
Change Control and Configuration Management
Testing and Validation
Training and Competence
Scalability and Flexibility
Resource Allocation and Investments
Adapting to Changing Regulatory Landscape
Enhanced Product Quality and Reliability
Reduced Risk and Security Breaches
Regulatory Compliance and Competitive Advantage
Customer Trust and Satisfaction
Summary

Why did I consider this important? The Information Technology (IT) industry is undergoing rapid growth, and technology plays a significant role in various aspects of our lives. As technology becomes increasingly critical and ubiquitous, it is essential to ensure that IT products and services adhere to stringent quality standards. What is GMP, and what does it mean? Good Manufacturing Practice (GMP), originally developed for the manufacturing sector, has now made its way into the IT industry. In this article, we delve into the world of GMP regulations in the IT sector, examining their significance, components, implementation challenges, and the benefits they bring to the industry. To establish a foundation for understanding the subject, a key factor is → UNDERSTANDING GMP REGULATIONS. We will attempt to present this by discussing the two most crucial aspects below in bullet points.

Origin and Evolution of GMP

Good Manufacturing Practice (GMP) originated in the pharmaceutical industry with the aim of ensuring the quality, safety, and effectiveness of medicinal products. Over time, the scope of GMP has been expanded to other industries such as food, beverages, cosmetics, and now, the IT industry as well. The purpose of Good Manufacturing Practice is to establish a comprehensive set of guidelines and principles that regulate production and manufacturing processes.

Adapting GMP for the IT Industry

Applying GMP principles in the IT industry focuses on ensuring the quality, reliability, and safety of software and technological products. GMP regulations in the IT sector encompass a wide range of aspects, including development methodology, documentation, testing, validation, change control, and regulatory compliance.

The essence of what I would like to discuss is the → SIGNIFICANCE OF GMP IN THE IT INDUSTRY. Why? I have been working in this sector for several years and consistently observe that it is met with reluctance by many colleagues in the industry. To approach the topic of quality with greater commitment, one must understand the unquestionable significance, which I will also outline in a few points below.

Ensuring Quality, What is GMP?

GMP regulations play a pivotal role in ensuring that software and IT products are developed, implemented, and maintained using robust quality management systems. This entails adhering to established programming methodologies (quality management), conducting meticulous testing and validation processes, and maintaining comprehensive documentation. By following GMP guidelines, organizations can ensure consistent and repeatable processes for delivering high-quality IT solutions to their clients.

Risk Mitigation

In the era of cyber threats and data breaches, GMP regulations (Good Manufacturing Practice) help identify and mitigate potential risks associated with IT products and services. By adhering to standardized processes and implementing appropriate forms of control, organizations can reduce the likelihood of software failures, security vulnerabilities, and breaches. GMP regulations emphasize the importance of risk management, known as software security, and promote the adoption of best practices to ensure the security and integrity of IT systems, including crucial data security.

Compliance and Auditability

Compliance with regulatory requirements and industry standards is a key aspect of GMP regulations, and adhering to them allows organizations to demonstrate their commitment to quality and regulatory compliance during audits and inspections. By implementing GMP practices, companies can establish robust systems for tracking and documenting compliance, ensuring transparency and accountability in their IT operations.

Customer Trust

One of the significant benefits of adhering to GMP regulations in the IT industry is the enhancement of customer trust. Customers are more inclined to rely on technological solutions that are reliable, secure, and compliant with industry standards. By following GMP principles, organizations can assure their customers that rigorous quality control measures are in place, fostering trust and loyalty.

Key Elements of GMP Regulations in IT

Documentation and Standard Operating Procedures (SOPs)

Comprehensive documentation forms the foundation of GMP regulations. IT organizations must maintain detailed records, including requirement specifications, design documents, test plans, and user instructions. SOPs (Standard Operating Procedures) contain step-by-step guidelines for performing various IT-related tasks, ensuring consistency and traceability throughout the software development cycle.

Change Control and Configuration Management

Precise change control procedures are crucial for managing software, hardware, and IT system modifications. GMP regulations highlight the importance of documenting and tracking changes, ensuring that any changes to IT products are controlled, reviewed, and approved. Proper configuration management practices help maintain control over software versions and configurations, ensuring stability and traceability.

Testing and Validation

Implemented and established testing and validation processes are integral to GMP regulations in the IT industry. These processes encompass functional testing, performance testing, security testing, and legal requirement validation. Organizations must implement comprehensive testing strategies to ensure that IT products and systems meet required standards of quality, reliability, and compliance.

Training and Competence

Well-trained personnel play a crucial role in GMP regulations, as they contribute to maintaining quality and compliance. Organizations must establish training programs along with competence assessments to ensure that their employees possess the knowledge and skills necessary for creating, implementing, and maintaining IT systems. By investing in employee training, organizations can enhance their overall ability to deliver high-quality IT solutions.

However, to fully reap the benefits of applying good manufacturing practice [GMP :)], one must first address → IMPLEMENTATION CHALLENGES AND ISSUES, which I will attempt to outline in the following points.

Scalability and Flexibility

Implementing GMP regulations in the IT industry can pose challenges related to scalability and flexibility. As technology evolves rapidly, organizations need to strike a balance between adhering to established processes and the need for innovation and flexibility. GMP practices should be adapted to changing technologies, methodologies, and regulatory requirements.

Resource Allocation and Investments

Implementing and maintaining GMP regulations require dedicated resources, including personnel, tools, and infrastructure. Organizations need to allocate sufficient resources, invest in training, documentation systems, testing, and compliance management tools. Resource allocation should align with the organization’s strategic goals and long-term stability.

Adaptation to Changing Regulatory Environment

The IT industry operates in a complex regulatory environment, where new regulations and standards are introduced frequently. Organizations must stay current with the evolving regulatory landscape while ensuring compliance of implemented GMP practices with the latest requirements. Thus, regulatory compliance is highly anticipated. Regular audits and other assessment methods help identify gaps to ensure continuous compliance. What → BENEFITS CAN BE GAINED FROM GMP REGULATIONS IN THE IT INDUSTRY? Awareness can lead project teams to approach quality documentation with greater dedication. Therefore, I will present key benefits in a few points below.

Enhanced Product Quality and Reliability

By adhering to GMP regulations, IT departments can ensure consistent product quality and reliability, meeting or exceeding customer expectations. A systematic approach to development, testing, and validation instills confidence in the quality of delivered IT solutions.

Reduced Risk and Security Breaches

GMP regulations serve as a framework for easier identification and consequent mitigation of risks associated with IT products and services. By implementing stringent security measures, organizations can minimize potential security breaches, data loss, and other cyber threats.

Regulatory Compliance and Competitive Advantage

Compliance with GMP regulations enables organizations to demonstrate their commitment to quality and regulatory requirements. This not only protects the organization from penalties and legal matters but also provides a competitive advantage in the market.

Customer Trust and Satisfaction

Adhering to GMP instills confidence that selected IT products and services meet industry standards in terms of quality, reliability, and security, leading to increased customer trust, satisfaction, and long-term collaboration.

Summary

In conclusion, in the rapidly evolving IT industry, GMP regulations have become pivotal for ensuring quality, reliability, and compliance. By adhering to GMP principles, organizations can enhance their quality management systems, mitigate risks, achieve regulatory compliance, and instill customer trust. Implementing GMP regulations requires a systematic and holistic approach, encompassing documentation, change control, testing, and training. While challenges exist, the benefits of adopting GMP in the IT industry far outweigh the efforts involved. Embracing GMP, organizations can thrive in a competitive landscape and contribute to building a technologically advanced and secure future.

By choosing to implement solutions alongside TTMS Quality, you will gain a competitive edge and establish solid foundations for the success of your project. Our specialists will collaborate with you to tailor the best solutions to your needs and objectives. We value quality and professionalism, so we are ready to support you at every stage to ensure the highest level of service.

Contact us today to learn how we can help you achieve your business goals. We are prepared to become your reliable partner in auditing, validation, and quality management, supporting you on the path to success.

Article prepared by:
Karolina Grzywacz,
Marika Juskowiak

What is GMP and its origin?

Good Manufacturing Practice (GMP) originated in the pharmaceutical industry to ensure the quality, safety, and effectiveness of medicinal products. Over time, GMP guidelines expanded to other industries, including food, beverages, cosmetics, and now the IT industry. GMP establishes comprehensive guidelines and principles to regulate production and manufacturing processes, ensuring consistent quality standards across various sectors.

How has GMP evolved for the IT industry?

Adapting GMP principles for the IT industry focuses on ensuring the quality, reliability, and safety of software and technological products. GMP regulations in IT cover development methodology, documentation, testing, validation, change control, and regulatory compliance. This adaptation aims to ensure that IT products and services meet rigorous quality standards, similar to those in the pharmaceutical and manufacturing sectors.

What is the significance of GMP in the IT industry?

GMP regulations play a crucial role in ensuring that software and IT products are developed, implemented, and maintained using robust quality management systems. This includes adhering to established programming methodologies, conducting meticulous testing and validation processes, and maintaining comprehensive documentation. By following GMP guidelines, organizations can deliver high-quality IT solutions consistently and reliably.

How does GMP help in risk mitigation?

GMP regulations help identify and mitigate potential risks associated with IT products and services, especially in the era of cyber threats and data breaches. By adhering to standardized processes and implementing appropriate controls, organizations can reduce the likelihood of software failures, security vulnerabilities, and breaches. GMP emphasizes risk management and promotes best practices to ensure the security and integrity of IT systems and data.

What is the role of compliance and auditability in GMP?

Compliance with regulatory requirements and industry standards is a key aspect of GMP regulations. Adhering to these guidelines allows organizations to demonstrate their commitment to quality and regulatory compliance during audits and inspections. Implementing GMP practices establishes robust systems for tracking and documenting compliance, ensuring transparency and accountability in IT operations.

How does GMP enhance customer trust?

Adhering to GMP regulations in the IT industry enhances customer trust by assuring them that the technological solutions provided are reliable, secure, and compliant with industry standards. By following GMP principles, organizations can show their customers that rigorous quality control measures are in place, fostering trust, satisfaction, and long-term collaboration.

What are the key elements of GMP regulations in IT?

Key elements of GMP regulations in IT include comprehensive documentation and Standard Operating Procedures (SOPs), precise change control and configuration management, thorough testing and validation processes, and well-established training programs for personnel. These elements ensure consistency, traceability, and high-quality standards throughout the software development cycle.

What are the challenges of implementing GMP in IT?

Implementing GMP in IT can pose challenges related to scalability and flexibility, as organizations need to balance adherence to established processes with the need for innovation. Dedicated resources, including personnel, tools, and infrastructure, are required to maintain GMP regulations. Additionally, organizations must stay current with the evolving regulatory landscape to ensure continuous compliance.

What are the benefits of adopting GMP regulations in the IT industry?

Adopting GMP regulations in the IT industry offers numerous benefits, including enhanced product quality and reliability, reduced risk and security breaches, regulatory compliance, and competitive advantage. By adhering to GMP, organizations can ensure their IT products meet industry standards, fostering customer trust and satisfaction.

How can TTMS help with GMP implementation in IT?

TTMS can help organizations implement GMP solutions by providing expertise in auditing, validation, and quality management. By collaborating with TTMS, companies can tailor solutions to their specific needs and objectives, ensuring the highest level of service and competitive advantage. TTMS supports organizations at every stage, from initial implementation to ongoing maintenance, to achieve business goals and success.

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How to Effectively Implement the NIS 2 Directive – A Practical Guide

In today’s digital landscape, information security is one of the key pillars of any organization’s operations. The NIS 2 Directive introduces a set of requirements and best practices designed to effectively protect businesses from modern cyber threats. Do you know how to prepare your organization to meet these standards? This guide provides actionable steps and insights to help you implement the NIS 2 Directive, ensuring the stability and security of your business operations. It’s time to elevate your protection standards—let’s get started! 1. Introduction to the NIS 2 Directive: Significance and Goals The NIS 2 Directive is more than just a set of regulations. It marks a new era in the European Union’s approach to cybersecurity. Imagine it as a shield protecting all of Europe from digital attacks. But what exactly is NIS 2? NIS 2 stands for the Network and Information Systems Directive 2. It is the next iteration of the original NIS Directive, aimed at strengthening cybersecurity across the EU. NIS 2 introduces new, more stringent protective measures. Why is NIS 2 so important? Consider the growing number of cyberattacks. Every day, businesses and institutions are targeted by hackers. NIS 2 is designed to establish a unified, high level of cybersecurity across the EU. The goals of the NIS 2 Directive are ambitious but crucial for our safety. First, it aims to enhance the resilience and responsiveness of both public and private entities. Second, it seeks to harmonize regulations across the EU, facilitating cooperation among member states. NIS 2 also introduces new obligations for businesses. More organizations are now required to implement cybersecurity measures. The directive also mandates faster incident reporting, enabling a more efficient response to threats. Implementing NIS 2 is not just a legal obligation—it’s an investment in your organization’s security. Think of it like insurance; it protects you from potential financial and reputational losses. Remember, NIS 2 is not just a challenge—it’s an opportunity to strengthen your organization. By adopting its measures, you can become a leader in cybersecurity. In the following sections, I will guide you step by step on how to achieve this. 2. Scope of the NIS 2 Directive: Who Needs to Comply? The question “Who does NIS 2 apply to?” is crucial for many organizations. The NIS 2 Directive expands the scope of entities covered by its regulations, encompassing additional sectors and increasing responsibilities for those already subject to similar requirements. This creates a more comprehensive protection system tailored to modern cybersecurity threats. NIS 2 covers two main categories of entities: “essential” and “important.” This distinction is critical, as it determines the obligations of companies. Essential entities are subject to stricter requirements. Essential entities include: Electricity and gas suppliers Distribution system operators Companies in the transportation sector (air, rail, water) Banks and financial institutions Healthcare service providers Important entities include: Postal and courier service providers Waste management companies Manufacturers of medical devices Companies in the chemical sector NIS 2 also extends to new sectors that were previously unregulated, such as public administration, space, and the production of medical devices. The directive also considers company size, requiring medium and large enterprises to comply. It’s worth noting that NIS 2 applies not only to EU-based companies. If you provide services within the EU, you must meet its requirements. This is particularly important for non-EU companies operating in the European market. Keep in mind that the list of entities covered by NIS 2 is extensive. If you’re unsure whether your organization falls under the directive’s scope, consult an expert. It’s better to be prepared than to risk penalties. NIS 2 is not just an obligation but also an opportunity. Complying with its requirements can enhance your company’s competitiveness. It demonstrates to clients and partners that you take security seriously. 3. Key Requirements and Obligations Under the NIS 2 Directive Understanding the requirements of NIS 2 is essential for successfully implementing the directive. Think of it as a roadmap guiding you through the labyrinth of cybersecurity. Let’s explore the key points of this roadmap. The fundamental requirement of NIS 2 is to implement appropriate safeguards. Your task is to protect systems and data from cyberattacks, akin to building a solid shield that effectively defends against all threats. Another crucial obligation is risk management. NIS 2 requires regular assessment of threats to your organization. This is like being a vigilant guard, constantly on the lookout for dangers. The directive places significant emphasis on incident reporting. You must report major incidents within 24 hours. Think of it as an early warning system for the entire EU. NIS 2 also mandates continuous system monitoring. You need tools to detect anomalies, much like keeping a watchful eye on every corner of your digital infrastructure. Supply chain management is another important aspect. NIS 2 requires you to evaluate the security of your suppliers, ensuring that the “bridge” you rely on is stable and secure. The directive also highlights the importance of education. You must train your employees in cybersecurity practices, effectively creating an army of defenders for your digital stronghold. Another requirement is to have a business continuity plan. You must be prepared for worst-case scenarios, similar to having an evacuation plan in case of a fire. Keep in mind that NIS 2 requirements vary depending on the type of organization. “Essential” entities face stricter obligations than “important” ones. Implementing these requirements might seem challenging, but remember, it’s an investment in your company’s security. It’s not only about meeting legal obligations but also about building trust with your clients. 4. Practical Tips for Implementing the NIS 2 Directive Implementing the NIS 2 Directive might seem complex, but don’t worry—I’ll guide you through the process step by step. Here are practical tips to effectively implement NIS 2 in your organization. 4.1 NIS 2 Audit The first step is to conduct a NIS 2 audit. Think of it as a detailed analysis of your digital infrastructure. Examine the security measures you already have in place and identify areas that need strengthening. Start by assessing your current security level and comparing it with the requirements of the NIS 2 Directive. Identify gaps and areas needing improvement, which will help you develop an effective action plan. Remember, an audit is not a one-time task but a continuous process. Regular audits will help you adapt to changing requirements and threats, maintaining the highest security standards. 4.2 Risk Analysis The next step is risk analysis—a cornerstone of successful NIS 2 implementation. Imagine yourself as a detective identifying potential threats. Identify all possible risks to your organization. Assess their potential impact and likelihood. Don’t forget risks associated with your supply chain. Risk analysis is an ongoing process. Regular updates will ensure you’re prepared for emerging threats. 4.3 Implementing Appropriate Security Measures Now it’s time to take action. Based on your audit and risk analysis, implement appropriate security measures. This is like building walls and placing guards around your digital fortress. Start with the basics: update operating systems and software, implement strong authentication mechanisms, and encrypt sensitive data. Don’t neglect network security. Install and configure firewalls, and deploy intrusion detection and prevention systems. 4.4 Developing Documentation and Procedures The NIS 2 Directive requires solid documentation, much like creating a map and instructions for your digital fortress. Develop clear security policies and procedures. Create an incident response plan outlining roles and responsibilities in the event of a cyberattack. Prepare incident reporting procedures in compliance with NIS 2 requirements. Don’t forget a business continuity plan detailing how your company will operate in case of a major incident. 4.5 Training Management and Staff Last but not least is education. The best security measures won’t help if your employees don’t know how to use them. Conduct training for all staff members. Teach them how to recognize threats and respond to incidents. Pay special attention to training management, ensuring they understand the importance of NIS 2 for the company. Remember, training is a continuous process. Regularly refresh employees’ knowledge and inform them about new threats and procedural changes. Implementing the NIS 2 Directive is not a sprint but a marathon. It requires ongoing effort and attention. However, with these practical tips, you’re on the right path to success. 5. Summary: The Strategic Importance of NIS 2 Compliance for EU Cybersecurity The NIS 2 Directive is more than just a set of regulations—it represents a strategic step toward enhancing cybersecurity across the European Union. Imagine it as a digital shield protecting the entire continent. Compliance with NIS 2 is crucial for businesses and institutions. It’s not just about avoiding penalties; it’s an investment in a secure future. Companies that implement NIS 2 will become more resilient to cyberattacks. NIS 2 establishes a common language for cybersecurity within the EU, making cross-border collaboration easier. It’s like building a bridge that connects all member states in the fight against cyber threats. It’s important to recognize that NIS 2 is not just a legal obligation but also an opportunity. Companies compliant with NIS 2 will be perceived as more trustworthy, potentially attracting new clients and partners. NIS 2 also fosters the development of a cybersecurity culture. It requires engagement from the entire organization, from top management to frontline employees. It’s like creating a cyber-defense army within every company. Cybersecurity is an ongoing process, and NIS 2 emphasizes continuous monitoring and improvement. It’s like consistently reinforcing the walls of your digital fortress. While implementing NIS 2 can be challenging, the benefits far outweigh the costs. It’s an investment in the security of your company and the entire EU. Every euro spent on NIS 2 is a step toward a safer digital future. Remember, you’re not alone on this journey. EU institutions, including EUR-NIS, offer support and guidance. Leverage the resources and expertise available. Together, we can build a stronger, more resilient digital Europe. 6. How Can TTMS Support You in Implementing the NIS 2 Directive? Implementing the NIS 2 Directive may seem like a complex process, but you don’t have to navigate it alone. TTMS is ready to be your guide and partner in this critical transition. TTMS is a team of cybersecurity experts with extensive experience in implementing complex regulations such as NIS 2. Our expertise allows us to provide comprehensive support throughout the implementation process—from start to finish. We begin with a thorough audit, assessing your organization’s current cybersecurity status and comparing it against the requirements of NIS 2. This will give you a clear understanding of the actions needed to achieve compliance. Next, we assist with risk analysis. Our specialists identify potential threats to your organization and work with you to develop strategies to minimize those risks. TTMS also supports you in selecting and implementing appropriate security tools, leveraging the latest technologies and best practices. We tailor solutions to your specific needs and budget, ensuring their effectiveness. We provide assistance in creating documentation and procedures, including security policies, incident response plans, and business continuity plans, all customized to fit the unique requirements of your business. An equally important element is team education. TTMS designs and conducts training programs for your staff—from management to operational employees—ensuring everyone knows how to operate in compliance with NIS 2 requirements. Our support doesn’t stop at implementation. TTMS offers ongoing system monitoring, incident response assistance, and updates on regulatory changes and emerging threats. Implementing NIS 2 is an ongoing process, and TTMS can be your long-term partner in maintaining compliance and security. With TTMS, implementing NIS 2 becomes simpler and more efficient—let us help you build a secure future for your organization. Contact TTMS today so our experts can learn about your needs and assist in developing solutions tailored to the challenges your business faces. Read our releted articles: Directive NIS 2: Challenges and Opportunities in Cybersecurity Who needs to comply with the NIS 2 Directive? The NIS 2 Directive applies to companies and organizations in key economic sectors, such as energy, transportation, healthcare, digital infrastructure, and ICT service providers. It also applies to essential and important service providers that meet specific size and significance criteria. What are the requirements of the NIS 2 Directive? Organizations must implement technical and organizational measures to ensure cybersecurity, including risk analysis, incident management, employee training, and network security measures. Additionally, security incidents must be reported to the appropriate authorities within a specified timeframe. Who does NIS 2 apply to? The NIS 2 Directive applies to entities in critical sectors such as energy, transportation, healthcare, digital infrastructure, and ICT service providers. It also includes important service providers if they meet certain size and significance criteria for the economy. What is NIS 2? NIS 2 is an EU cybersecurity directive that replaces the earlier NIS directive, introducing stricter requirements for companies and organizations in key sectors. Its goal is to enhance resilience against cyber threats and improve collaboration among EU member states.

Digital Transformation and Penguins: How to Analyze, Process, and Store Data in 2024?

Some species of penguins fall asleep 10,000 times a day. It’s a bit like parents of young children who wake up every five minutes to check if the baby is breathing, to change a diaper, or to feed the infant. Falling asleep 10,000 times a day sounds unbelievable but also fascinating. Nature can be almost as surprising as the idea of penguin researchers studying their sleep habits might seem to the average person. When I think about the amount of data that must have been collected regarding this phenomenon, questions come to mind: How can something like this be studied? How can such a vast amount of data, stemming from this gigantic number of sleep cycles, be analyzed? 1. Why does humanity collect information in the first place? To understand the intricate nature of researchers who had enough determination to observe penguins’ habitats, let’s go back to the beginning. Humanity has been gathering information for thousands of years. Our species intuitively knows that more information leads to better and faster decision-making, a better understanding of the root of problems and complex issues, as well as safety and threat prevention. Initially, information was collected through oral transmissions, then cave paintings, and later increasingly advanced forms of writing. The transmission of knowledge through writing became commonplace. Initially, the ability to read and write was available only to the wealthiest and the clergy during the Middle Ages. These were the two social groups that once had exclusive access to information conveyed in writing. Over time—with the development of content duplication techniques like printing—the transmission of information became the cause of rapid growth in education and knowledge. The swift development of available printed materials fueled the popularization of literacy skills. More people with these skills accelerated the development of science and industry. The faster advancement of science and industry, in turn, meant that humans could allocate more resources to further scientific progress and conduct more complex research. At a certain point, we reached a stage where processing data obtained during experiments in paper form was not efficient. Data began to be collected electronically. The emergence of the global internet network was another impulse that accelerated the amount of data being collected, processed, and disseminated. 2. The Excel Era Let’s take a moment to jump back in time to 1985. That’s when Excel was born—a marvelous tool for collecting, processing, distributing, and visualizing data. It allowed users to create forecasts, charts, tables, complex formulas, and even macros that helped quickly process large amounts of data. The possibilities of using spreadsheets were essentially limited only by the users’ imagination. However, over time, we began to hit the spreadsheet wall. Using them as databases, scheduling tools, or for statistical analysis of vast amounts of data led to the creation of “monsters” several gigabytes in size that could bring any computer to a halt. They also made it impossible to use them on multiple devices simultaneously. Spreadsheets were also unsuitable for storing important information due to technical limitations, such as the lack of version history for changes made to the file. It’s no surprise that over time, this tool began to encounter its own limitations. Applying Excel to tasks it wasn’t originally designed for—like database management or complex statistical analysis—led to performance and technical problems. As a result, despite its versatility, Excel did not meet all the requirements of modern organizations, highlighting the need for more advanced tools. 3. I Appreciate You, but I’m Leaving: Saying Goodbye to Excel Every enterprise must mature enough to step out of the “Excel cage.” Its versatility means it’s pretty good for everything… but only pretty good. As processes become more complex, it’s necessary to use specialized tools that ensure security and quick analysis of key data and processes. To illustrate this problem, one might attempt to draw a timeline with specific points: from a finger smeared in dye, through cuneiform writing, paper, Excel, all the way to AI. There’s no going back to cave paintings—that seems logical to us. Yet we still have to convince others that the paper era is over, and Excel’s time has just ended. In times when humanity is producing more and more data every day, can we afford to use paper? Paper, which is only slightly better than a clay tablet? These are, of course, rhetorical questions. Regarding the penguins—to check if a bird is sleeping, it was necessary to analyze much more than just its sleep. Parameters such as brain electrical activity (independently for each hemisphere), body movements, neck muscle activity, and even the depths at which the birds hunted fish in the ocean were examined. The observation results were surprising. It turned out that the birds didn’t sleep for long periods. An average penguin nap lasted 1–4 seconds. However, it’s worth mentioning that there could be several hundred such naps per hour. When summing up all the moments devoted to sleep, it turned out that the animals could sleep up to 15 hours a day. In this particular case, Excel was sufficient because the analysis was conducted for only 14 individuals. However, as you might guess, with a larger number, computational tool performance issues could arise. 4. How to Analyze, Process, and Store Data in 2024 The aforementioned penguins were studied for parameters that could indicate they were falling asleep. They would fall asleep for a few seconds, even up to 600 times an hour. This means that measurements had to be taken at a frequency of at least every 0.5 seconds. One parameter would occupy 170,000 cells in a spreadsheet for just one bird per day. Over 10 days, this amount would increase to 1,700,000. Multiplying this result by 14 (the total number of studied individuals), we get nearly 24 million cells. If we then multiply this by 10 different parameters (which were also studied), we obtain 240 million cells filled with the vital parameters of 14 penguins. If we measure even more parameters, we hit the wall of the spreadsheet’s cell limit. A similar problem occurs in any quality process we might want to conduct using Excel. If the process requires implementing an audit trail (a chronological record of all operations), the spreadsheet’s size begins to increase very rapidly. Of course, Excel is a much better place to store data than the clay tablets and papyrus mentioned multiple times in this article. However, it is not suitable for use as a database. That’s why dedicated tools are used for data collection. Here are a few of them: MES Systems (Manufacturing Execution System): Systems for supervising and controlling the production process, ensuring proper parameters and efficiency, allowing you to monitor and plan production processes. ERP Systems (Enterprise Resource Planning): Help in managing the entire enterprise. EDMS (Electronic Document Management System): Enable and facilitate control over the quality and availability of documents. All the above categories (and many others) require proper infrastructure and maintenance. It’s worth mentioning that each of these systems can be supported to some extent by AI. Performing scoring and analyzing vast amounts of data is something AI excels at. This allows for optimizing processes in ways not available in simple tools like Excel. In many cases, including the validation of computerized systems, determining user requirements and properly understanding their needs is crucial for the safe and efficient operation of any computer system—by the user themselves as well. “Blind optimism” from the client, which may arise after an excellent sales presentation of a system’s demo version, is not good practice because it usually doesn’t consider the real business needs, system capabilities, and infrastructure. Suppliers are generally interested in good cooperation with the client and providing what they genuinely need, but they often can’t spend enough time with them to assess their real needs. This is especially true when implementing a tool is something new, and the user isn’t always aware of their needs (e.g., validation and change tracking, which may turn out to be required—something Excel does not support to the extent needed for large amounts of data. An improperly chosen tool may require unfeasible customizations to implement the proper solution). For example, the penguin researchers started by developing a methodology, checking previous publications on the subject, and considering what needed to be studied to obtain specific data. In computer systems, this stage is called “defining user requirements”. To enable a company to effectively determine what functionalities a new system for collecting, storing, and processing data—meant to replace Excel—should have, it’s worth going through several key steps: Analysis of Business Requirements: The company should gather and analyze all needs and goals related to data across the organization. It’s important to understand which processes are to be supported by the new system and what specific problems need to be solved. Engagement of Key Users: It’s beneficial to conduct interviews, surveys, or workshops with employees who currently use Excel. This way, you can learn about their daily needs and discover the limitations and challenges they face. Mapping Processes and Data Flows: The company should trace how data flows in different departments. Clear process mapping allows for identifying which functionalities are needed to automate, streamline, or integrate different stages of working with data. Identification of Key Functions and Excel’s Shortcomings: Analyzing where Excel does not meet expectations is crucial. For example, there may be a lack of simultaneous multi-user access, advanced reporting, real-time analysis, integration with other systems, or ensuring an appropriate level of security. Analysis of Available Technologies and Solutions: The company should explore market-available solutions that offer functionalities required to achieve the set goals. Defining Priorities and Essential Functionalities: After gathering all requirements, the company should create a prioritized list of functionalities. Key functions may include storing large volumes of data, real-time analytics, automatic reporting, data security, or the ability to integrate with other systems. Testing Solutions: If possible, it’s worth conducting tests of selected solutions with the participation of end-users. This will allow the company to assess how new functions work in practice and whether they meet the employees’ needs. Selecting a Vendor and Pilot Implementation: After initial tests, the company can choose a system vendor that best meets the requirements and conduct a pilot implementation. Such a pilot allows for adapting the system to the company’s specific work environment before full deployment. By going through these steps, the company will be able to precisely determine what functionalities are needed in the new system and choose a solution that best fits its requirements. That’s why more and more enterprises, especially in industries where data collection is crucial, are moving away from spreadsheets in favor of more advanced tools. This is an obvious consequence resulting from the growth of every company. 5. Modern Data Management – Summary and Conclusions I have addressed the complexity of collecting, storing, and analyzing data using the example of research on penguin sleep to show that transitioning from Excel to dedicated systems like ERP, MES, and EDMS is necessary. Such solutions are indispensable for companies processing vast amounts of data. In the digital age, traditional spreadsheets no longer meet the needs of dynamic businesses, and optimal data management requires professional tools and an understanding of real user requirements. Returning to the topic of the penguins themselves—imagine someone falling asleep and waking up 600 times an hour. You could say they are almost always asleep, waking only to take care of something. This resembles a user during system implementation who hasn’t thoroughly considered their needs. It is the user and their needs that are crucial in any implementation. Often, the user cannot properly define their expectations, is unaware of the necessity of conducting validation, or conversely—thinks it is essential, leading to unnecessary expenses. “Overquality”—this is a word I just invented, but it aptly describes the phenomenon of excessive attention to quality. And what about “underquality”? Here, the issue is much more serious—it can lead to disruptions in key business processes, endangering patient safety, product quality, and reducing the company’s profitability. And what does this have to do with Excel? Every enterprise should care about the safety and efficiency of its business processes. To achieve this, these processes should be supported by appropriate tools that specialists in this field can provide. If this article interested you, if you have questions or need support in digital transformation, leave us a message. Our team of Quality Management experts will help meet your expectations in the area of digital change. Meet our case studies in data management and digital transformation: Automated Workforce Management System Case Study Supply Chain Management Case Study: Cost Improvement Case Study: Customized Finance Management System in Enterprise Example of How We Improved Reporting and Data Analysis Efficiency Consent Management Platform Integration in Pharma Case Study Effective Consent Lifecycle Management in Pharma Case Study Global Coaching Transformation at BVB with Coachbetter App A Pharma Platform Case Study – Implementing a Digital Health Operation Crocodile – building a new service center

What’s New in Microsoft Teams: November 2024

Microsoft Teams is continuously evolving, delivering new features and improvements that enhance user experience and optimize daily workflows. From Teams Rooms enhancements to chat and channel upgrades, and improved meeting and calling functionalities, Microsoft Teams aims to support both remote and in-office teams in dynamic work environments. As a Microsoft partner, our company, TTMS, is excited about the possibilities these updates bring to foster better collaboration and user convenience. Here’s an overview of the latest features and how they benefit Teams users. 1. Easier Management of Information and Teams A new info panel in 1:1 and group chats enables quick access to key resources, including a participant list, pinned messages, shared files, and a search option. This feature is particularly helpful for users who frequently revisit important information or need to search through chat histories when collaborating on projects. Additionally, the revamped view of teams and channels provides a clear organizational structure, with options to filter and manage projects, and access analytical insights. Now, as the number of channels and teams grows, employees can more easily find the information they need. A screenshot of this new team and channel structure, highlighting its management options, will make it easier for users to understand these updates. 2. Improved Meeting and Webinar Experience Teams now offers notifications of completed meeting summaries in the Activity feed, allowing users to quickly review key points even if they couldn’t attend the meeting. Adding a screenshot of this notification will illustrate how simple it has become to manage such summaries. Meeting organizers also have new controls over admitting participants from the lobby, deciding who has access to the meeting. This flexibility is especially useful in larger meetings, as organizers can grant access rights to co-organizers and presenters. A screenshot of these settings can help illustrate how easy it is to manage meeting access. Thanks to voice isolation for MacOS, remote workers can now enjoy clearer sound by eliminating background noise. Using AI, this feature filters out unwanted sounds, providing a distraction-free meeting experience – a function especially valued by remote teams. 3. New Tools for Managing Large-Scale Events For organizers of large-scale events like Town Halls, webinars, and training sessions, Microsoft Teams now offers enhanced tools to streamline the entire process of managing participants and communications. One of the key improvements is the ability to integrate with external email platforms, enabling organizers to handle event-related communication from within Teams in a much more efficient manner. This integration allows organizers and co-organizers to send a range of messages, such as invitations, reminders, follow-ups, and updates, directly to participants’ inboxes, eliminating the need to switch between multiple platforms. For instance, organizers can set up automated reminders for registrants, confirm attendance, or even send personalized thank-you notes after the event, ensuring that participants remain engaged throughout the event lifecycle. This streamlined approach enhances the overall experience, allowing hosts to focus more on content delivery and less on administrative tasks. In addition to communication improvements, Teams also provides expanded control settings for admitting attendees. With these new controls, organizers can specify who has permission to allow participants into the event from the lobby, whether it’s just the organizer or also co-organizers and presenters. This flexibility is particularly useful for managing large or complex sessions where different team members might need to take on specific roles, ensuring a smooth and efficient start to each meeting or presentation. These updates not only enhance the logistical side of event management but also create a more polished experience for attendees, who benefit from timely communications and efficient event handling. A few well-placed screenshots of the integration with email platforms and the lobby management controls can effectively illustrate how these tools make large-scale event management simpler and more effective in Teams. 4. Teams Phone: Professional Call Queue Management For organizations that rely on phone calls, the new Queues app in Teams Phone offers significant benefits. Agents can make calls on behalf of call queues and auto attendants, while supervisors have real-time visibility into call statistics and can monitor conversations. This feature will be particularly valuable to customer service teams, and screenshots of the Queue app’s interface can help illustrate the management possibilities it brings to customer support. 5. Digital Signage in Microsoft Teams Rooms The new digital signage feature in Teams Rooms on Windows allows companies to leverage unused screens in meeting rooms to display dynamic content, such as company communications, news, guidelines, or announcements. Integration with providers like Appspace and XOGO further expands the scope of this feature. A screenshot showing an example of this dynamic signage will demonstrate how companies can maximize their workspace for internal communication. For organizations that use multiple meeting platforms, Microsoft Teams Rooms now allows users to join meetings on other platforms such as Google Meet, Zoom, and Cisco Webex. This cross-platform support is especially useful for teams working with clients and partners who use various solutions. A screenshot of an inter-platform meeting in progress can help visualize this new functionality. 6. Custom Branding for Meetings with Frosted Glass Effect The frosted glass effect for meeting backgrounds is a feature that allows companies to add a subtle, professional touch to their Teams meetings by displaying a blurred logo or brand element in the background. This effect can enhance the look of your meetings, providing a clean and sophisticated branded experience. Here’s a quick guide on how to apply this effect: Open Microsoft Teams and start a new meeting or join an existing one. Once in the meeting, click on the More Actions button (represented by three dots). Select Apply background effects from the dropdown menu. In the background effects menu, choose or upload a custom image with your logo that includes a frosted or blurred effect. If needed, you can design a background in a graphics editor to add your logo with a frosted effect. Apply the chosen background by clicking Preview to check how it looks and then select Apply to set it as your background for the meeting. This setup helps your branding look modern and appealing, while maintaining a minimalist and unobtrusive presence in your meetings. 7. Summary The latest Microsoft Teams updates provide companies with innovative tools to enhance efficiency, user experience, and workplace positivity. From the new info panel to the Queue app and frosted glass branding, Microsoft’s enhancements align with the evolving needs of modern businesses. At TTMS, as a Microsoft partner, we offer comprehensive support for Microsoft 365 solutions, enabling seamless collaboration, data security, and tailored productivity tools. These recent innovations represent another step towards excellence in providing solutions that not only support teamwork and workflow but also strengthen brand integrity and trust. Contact us now! Explore our previous articles about Microsoft Teams: TTMS Blog – The World Through the Eyes of IT Experts What is the new info panel in Microsoft Teams, and how can it help me? The info panel in 1:1 and group chats allows quick access to essential resources, such as a participant list, pinned messages, shared files, and a search option. This feature is especially useful for users who frequently need to revisit key information, making it easier to locate details without scrolling through long chat histories. This panel streamlines project collaboration and communication within Teams, helping teams work more efficiently. How do meeting organizers manage large-scale events like webinars more effectively now? Microsoft Teams has introduced enhanced tools for large-scale event management, such as integrating external email platforms directly within Teams. This integration allows organizers to send event-related messages like invitations, reminders, and follow-ups straight to participants’ inboxes. Additionally, organizers now have more control over lobby permissions, making it easier to manage participant access during large meetings, ensuring smoother event operations. What benefits does the Queues app in Teams Phone bring to customer service teams? The new Queues app allows customer service agents to handle calls more efficiently, including making calls on behalf of queues and monitoring call data. Team leaders can track call statistics and monitor conversations in real-time, which helps in managing high call volumes. This feature is especially valuable for customer service teams, as it provides essential tools for effective call management and customer support. How can companies use the frosted glass effect for branding in Teams meetings? The frosted glass effect enables companies to add a subtle branding element to their Teams meetings by displaying a blurred logo or brand element in the background. This effect helps companies maintain a professional and clean look during meetings, without overwhelming the space with branding. Users can activate this effect in their background settings by selecting or uploading a custom image with a frosted effect, adding a modern and polished touch to their online presence. How does the digital signage feature work in Teams Rooms, and what are its benefits? The digital signage feature in Teams Rooms allows companies to use idle screens in meeting rooms to display dynamic content, such as company news, announcements, and guidelines. This feature, available on Windows, integrates with providers like Appspace and XOGO, enabling organizations to maximize the value of their meeting spaces for internal communication. It’s a great way to make efficient use of equipment and to keep employees informed and engaged within the workplace.

How to Effectively Train Employees on Cyber Security?

The biggest vulnerability in any organization’s cybersecurity isn’t outdated software or weak firewalls – it’s people. Imagine this: one innocent click on an email attachment could cripple an entire business. Alarming, right? Yet this is the challenge companies face daily. With cyber threats constantly advancing, employees play a more crucial role than ever in protecting sensitive information. So how can businesses effectively prepare their teams to be the first line of defense? Let’s explore how targeted cybersecurity training can turn your staff from potential risks into the protectors of your digital assets. 1. Introduction – understanding the role of employees in safeguarding data In the realm of cybersecurity, employees are both the greatest asset and the most significant potential liability. They are the gatekeepers of sensitive information, the decision-makers in countless digital interactions, and often the first to encounter cyber threats. Yet, many organizations underestimate the pivotal role their workforce plays in maintaining a robust security posture. Consider this startling statistic: 82% of data breaches have been linked to human-related security weaknesses, such as employees succumbing to phishing attacks and other forms of social engineering. This figure underscores the urgent need for comprehensive employee training in cybersecurity best practices. It’s not just about having the latest security software or the most advanced firewalls; it’s about equipping your team with the knowledge and skills to recognize and respond to potential threats. Employees interact with sensitive data daily, whether it’s customer information, financial records, or proprietary company secrets. Each email opened, each link clicked, and each file downloaded represents a potential entry point for cybercriminals. By understanding their role in safeguarding this data, employees become active participants in the organization’s security strategy rather than passive bystanders. Effective cybersecurity training transforms employees from potential weak points into a human firewall. It empowers them to make informed decisions, spot red flags, and take appropriate action when faced with suspicious activities. This shift from vulnerability to vigilance can dramatically reduce the risk of successful cyber attacks and data breaches, protecting not only the organization but also its clients, partners, and reputation. 2. Comprehensive Cybersecurity Strategies through e-Learning In today’s digital age, implementing robust cybersecurity strategies is no longer optional – it’s a necessity. E-Learning has emerged as a powerful tool for delivering comprehensive cybersecurity training for employees, offering flexibility and scalability that traditional methods often lack. Let’s explore how organizations can leverage e-Learning to create a strong cybersecurity foundation. 2.1 Developing a Strong Cybersecurity Policy A strong cybersecurity policy forms the backbone of any effective security strategy. Through e-Learning platforms, organizations can easily disseminate and explain their cybersecurity policies to all staff members. These online modules can break down complex policy documents into digestible, interactive lessons, ensuring that every employee understands their role in maintaining the company’s security posture. E-Learning allows for the creation of scenario-based training that puts policy into practice. Employees can engage with real-world situations, making decisions based on the company’s cybersecurity policy. This hands-on approach reinforces learning and helps staff internalize the policy’s key points. 2.2 Ensuring Compliance with Security Protocols Compliance is crucial in cybersecurity, and e-learning provides an efficient way to ensure all employees are on the same page. Cybersecurity staff training through e-Learning platforms can include regular assessments and quizzes to verify that employees understand and can apply security protocols correctly. These platforms can also track completion rates and performance metrics, allowing organizations to identify areas where additional training may be needed. This data-driven approach ensures that cybersecurity awareness training for employees is not just a one-time event but an ongoing process of improvement and reinforcement. 2.3 Effective Password Management Practices Password management is a critical component of cybersecurity, and e-Learning can make teaching these practices more engaging and memorable. Interactive modules can guide employees through the process of creating strong, unique passwords and demonstrate the risks associated with poor password habits. E-Learning platforms can also incorporate password management tools and techniques into their lessons, providing hands-on experience with password managers and multi-factor authentication systems. This practical approach helps employees integrate these crucial practices into their daily routines. 2.4 Regular Cybersecurity Updates and Training The cybersecurity landscape is constantly evolving, and employee training must keep pace. E-Learning platforms excel at delivering regular updates and refresher courses to keep staff informed about the latest threats and best practices. These platforms can push out quick, targeted lessons in response to emerging threats or changes in company policy. The global security awareness training market is predicted to exceed $10 billion annually by 2027, up from around $5.6 billion in 2023, based on 15 percent year-over-year growth. This growth underscores the increasing recognition of the importance of ongoing cybersecurity training for employees. By investing in robust e-Learning solutions, organizations can ensure their staff remains vigilant and up-to-date in an ever-changing digital landscape. 2.5 Educating employees on the variety of cyber threats and prevention A comprehensive cybersecurity awareness training for employees must cover a wide range of potential threats. E-Learning platforms can provide a diverse curriculum that includes modules on phishing, malware, social engineering, and other common attack vectors. These lessons can be tailored to different roles within the organization, ensuring that each employee receives training relevant to their specific responsibilities and risk exposure. Interactive simulations and gamified learning experiences can make this education more engaging and effective. For instance, employees can participate in simulated phishing exercises or compete in cybersecurity quizzes, reinforcing their knowledge while keeping them engaged in the learning process. By leveraging e-Learning for employee cybersecurity awareness training, organizations can create a culture of security consciousness. This approach not only educates staff but also empowers them to become active participants in the company’s cybersecurity efforts, transforming them from potential vulnerabilities into a robust first line of defense against cyber threats. 3. Key Actions for Effective Employees Cybersecurity Training Implementing a robust cyber security training for employees is crucial in today’s digital landscape. With cyber threats evolving rapidly, organizations must equip their staff with the knowledge and skills to protect sensitive information. Let’s explore the key actions that can make employee data security training more effective. 3.1 Creating and Managing Strong Passwords One of the fundamental aspects of cybersecurity employee training is teaching the art of creating and managing strong passwords. Employees should understand the importance of using complex, unique passwords for each account. Training should cover: The characteristics of a strong password (length, complexity, uniqueness) The risks associated with weak or reused passwords The benefits of using password managers The importance of regularly updating passwords 55% of companies do not provide even basic email security training, which often includes password management. By addressing this gap, organizations can significantly enhance their security posture. 3.2 Securing Devices and Data Cyber security training for staff should emphasize the importance of securing both company and personal devices. This includes: Keeping software and operating systems up-to-date Using antivirus and anti-malware software Encrypting sensitive data Properly disposing of old devices and data Understanding the risks of using public Wi-Fi networks Employees should also be trained on the company’s policies regarding bring-your-own-device (BYOD) practices and the secure use of company devices outside the office. 3.3 Recognizing Phishing Attempts and Suspicious Activities Phishing remains one of the most common and effective cyber attack vectors. Only about half (52%) of organizations conduct anti-phishing training, leaving a significant vulnerability. Effective cyber security training for employees should include: Identifying common phishing tactic Recognizing suspicious email characteristics Verifying sender identities before taking action Reporting suspected phishing attempts Understanding the risks of social engineering Practical exercises, such as simulated phishing campaigns, can help employees apply their knowledge in real-world scenarios. 3.4 Safe internet and email usage guidelines Cyber security training for staff should cover best practices for safe internet and email usage. This includes: Avoiding suspicious downloads and attachments Being cautious with links, especially in unsolicited emails Understanding the risks of oversharing on social media Using secure, encrypted connections when possible Recognizing and avoiding potentially malicious websites 45% of employees report receiving no security training from their employers, highlighting the need for comprehensive guidelines on safe online behavior. 3.5 Importance of Data Backups Employee data security training should emphasize the critical role of regular backups in protecting against data loss and ransomware attacks. Key points to cover include: The 3-2-1 backup rule (3 copies, 2 different media, 1 offsite) How to perform backups correctly The frequency of backups Testing backup restoration processes The role of cloud storage in backup strategies Over 30% of organizations offer ransomware-focused security training, but this number needs to increase given the rising threat of ransomware attacks. By focusing on these key actions in cybersecurity employee training, organizations can significantly improve their security posture. However, it’s important to note that companies lack sufficient security awareness training to reap significant benefits. This underscores the need for comprehensive, ongoing cyber security training for employees that covers all these crucial areas. Remember, effective training is not a one-time event but an ongoing process. Regular updates, refresher courses, and practical exercises are essential to keep employees vigilant and prepared to face evolving cyber threats. 4. Building a Culture of Cyber Security Awareness Creating a robust cybersecurity culture is essential for any organization aiming to protect its digital assets effectively. It’s not just about implementing the right technologies; it’s about fostering an environment where every employee understands their role in maintaining security. Let’s explore how to build this culture through comprehensive cybersecurity awareness training for employees. 4.1 Actively promoting cybersecurity awareness To build a strong culture of cybersecurity, organizations must actively and consistently promote awareness. This goes beyond occasional training sessions; it involves integrating cybersecurity best practices for employees into the fabric of daily operations. Here are some effective strategies: Regular communication: Send out cybersecurity tips, updates, and reminders through various channels like email, internal newsletters, or company intranets. Visual cues: Use posters, screensavers, and digital signage to reinforce key security messages. Leadership involvement: Encourage executives and managers to lead by example and emphasize the importance of cybersecurity in their communications. Cyber security training tailored to user roles and needs One-size-fits-all approaches to cybersecurity training often fall short. To truly educate employees effectively, organizations should tailor their employee cybersecurity awareness training programs to specific roles and needs within the company. Consider the following: Role-based training: Develop modules that address the unique security challenges faced by different departments (e.g., finance, HR, IT). Skill-level appropriate content: Offer basic, intermediate, and advanced training options to cater to varying levels of technical expertise. Industry-specific scenarios: Include examples and case studies relevant to your organization’s sector to make the training more relatable and applicable. By customizing the training experience, you can ensure that employees receive the most relevant and impactful information for their specific roles and responsibilities. 4.2 Encouraging employees to behave safely Building a culture of cybersecurity awareness isn’t just about imparting knowledge; it’s about inspiring action. To encourage safe behavior, consider these strategies: Gamification: Implement cybersecurity challenges, quizzes, or simulations with rewards for participation and good performance. Recognition programs: Acknowledge and reward employees who consistently demonstrate good cybersecurity practices. Open communication: Create channels for employees to report suspicious activities or ask questions without fear of reprimand. Continuous learning: Offer ongoing opportunities for employees to expand their cybersecurity knowledge through workshops, webinars, or certifications. By actively promoting awareness, tailoring training to specific needs, and encouraging safe behavior, organizations can create a robust culture of cybersecurity. This culture not only helps protect against threats but also empowers employees to become proactive guardians of the company’s digital assets. Remember, building this culture is an ongoing process. It requires consistent effort, regular updates to training materials, and a commitment to making cybersecurity a core value of your organization. With time and dedication, you can transform your workforce into a human firewall, capable of recognizing and responding to cyber threats effectively. 5. Summary – how to achieve cyber security goals with e-Learning E-Learning has revolutionized the way organizations approach cybersecurity training, offering a flexible, scalable, and effective solution to educate employees and strengthen their digital defenses. By leveraging e-Learning platforms, companies can achieve their cybersecurity goals more efficiently and comprehensively. Here’s a summary of how to make the most of e-Learning in your cybersecurity strategy: Develop comprehensive, role-specific training modules that address the unique challenges faced by different departments within your organization. Utilize interactive content, such as simulations and gamified learning experiences, to engage employees and make complex cybersecurity concepts more accessible and memorable. Implement regular assessments and quizzes to ensure employees retain the information and can apply it in real-world scenarios. Provide ongoing training and updates to keep pace with the ever-evolving cybersecurity landscape, ensuring your workforce remains vigilant against new threats. Use data analytics from e-Learning platforms to identify areas where additional training may be needed and to track the overall effectiveness of your cybersecurity awareness program. Incorporate real-world examples and case studies to illustrate the importance of cybersecurity practices and the potential consequences of lapses. Offer self-paced learning options to accommodate different learning styles and busy schedules, making it easier for employees to engage with the material. Create a culture of continuous learning by providing resources for employees to expand their cybersecurity knowledge beyond the required training. By embracing e-Learning as a cornerstone of your cybersecurity strategy, you can transform your employees from potential vulnerabilities into a robust first line of defense. This approach not only helps protect your organization’s digital assets but also empowers your workforce with valuable skills that are increasingly crucial in today’s interconnected world. Remember, achieving cybersecurity goals is an ongoing process. E-Learning provides the flexibility and adaptability needed to keep your organization’s defenses strong in the face of evolving threats. By investing in comprehensive, engaging, and up-to-date e-Learning resources, you’re investing in the long-term security and resilience of your organization. 6. How TTMS Can Equip Your Employees to Stay Cyber Safe At TTMS, we understand that the human element is crucial in maintaining a robust cybersecurity posture. That’s why we offer comprehensive cyber security training for employees that goes beyond traditional methods. Our approach is designed to transform your workforce into a formidable line of defense against digital threats. Our cybersecurity training for staff can be tailored to meet the unique needs of your organization. We recognize that different roles within your company face distinct challenges, and our programs can reflect this diversity. Whether it’s your IT team, management, or front-line employees, we provide role-specific training that resonates with their day-to-day responsibilities. TTMS’s cybersecurity training for employees can be built on a foundation of engaging, interactive content. We utilize cutting-edge e-Learning technologies to deliver: Scenario-based simulations that mimic real-world cyber threats Gamified learning experiences that make security concepts memorable Regular assessments to reinforce knowledge retention Bite-sized modules for easy integration into busy schedules Your employee cybersecurity awareness training doesn’t have to focus only on theoretical knowledge. We can emphasize practical skills that your staff can immediately apply in their daily work. From recognizing phishing attempts to understanding the importance of strong password management, we cover all aspects of cybersecurity that are relevant to your employees. What sets TTMS apart is our commitment to ongoing support and education. We don’t believe in one-off training sessions. Instead, we can help you to: Update your training regularly to keep your team informed about emerging threats Refresh courses to reinforce key concepts Prepare tools to analyze and report progress and identify areas for improvement By partnering with TTMS for your cyber security training for employees, you’re not just ticking a box for compliance. You’re investing in a culture of cybersecurity awareness that permeates every level of your organization. Our goal is to empower your employees, turning them from potential vulnerabilities into your strongest asset in the fight against cyber threats. Remember, in today’s digital landscape, cybersecurity is everyone’s responsibility. With TTMS’s comprehensive training solutions, you can ensure that every member of your team is equipped with the knowledge and skills they need to keep your organization safe. Let us help you build a cyber-aware workforce that stands ready to face the challenges of the digital age. Contact us now! Learn about our case studies of e-learning solution implementations: Healthcare E-learning Solution Example: Training Upgrade Using AI in Corporate Training Development: Case Study The Example of Safety Training: 10 Life-Saving Rules for Hitachi Energy Safety first and more: Explore TTMS Case Studies: Proven Success Across Industries

Understanding the NIS2 Directive: New Challenges and Opportunities in Cybersecurity

In the digital era, where data is the new gold, cybersecurity has become a paramount priority. Imagine a world where every mouse click could potentially open a gateway for cybercriminals. Does it sound like a science fiction movie plot? Unfortunately, this is our reality. But there is hope. The European Union is implementing new regulations to protect us. The NIS2 Directive is a response to the increasing threats in cyberspace. It acts like a new, powerful shield for our data. In this article, we will delve into the world of NIS2. Discover how this regulation will transform the cybersecurity landscape in Europe. Prepare for an exciting journey through the world of modern digital protections. 1. What is the NIS2 Directive and Why is it Significant for Cybersecurity in Europe? The NIS2 Directive is a new European Union regulation in the realm of cybersecurity. “NIS2” stands for “Network and Information Systems,” succeeding the original NIS Directive from 2016. Think of NIS2 as an updated, enhanced version of popular software, introducing a range of changes and improvements over its predecessor. Why is NIS2 so important? Imagine that your business is a castle. The original NIS Directive was like basic fortifications—walls and gates. NIS2 adds a modern alarm system, cameras, and guards to that. It’s a comprehensive protection against digital threats. The significance of NIS2 for Europe cannot be overstated. In a world where cyberattacks are becoming increasingly sophisticated, we need stronger defenses. NIS2 provides that protection. It covers a wider range of sectors and companies than the previous version, meaning more organizations will need to meet higher security standards. NIS2 also introduces more stringent requirements for incident reporting. It acts like an early warning system for all of Europe. This allows us to react quicker to threats and better protect ourselves—a critical advantage in an era where every second can determine the success or failure of a cyberattack. The NIS2 Directive is not just a set of regulations; it’s a strategy for the whole of Europe. It aims to create a unified, strong front against cyber threats. NIS2 promotes cooperation among member states in cybersecurity, akin to creating a European cyber defense army. For businesses operating in Europe, NIS2 means new obligations. But it also presents an opportunity—an opportunity to raise security standards and build customer trust. Companies that quickly adapt to NIS2 can gain a competitive edge and become leaders in cybersecurity. NIS2 is a response to the increasing digitization of our lives. More and more services are moving online, from banking to healthcare. NIS2 ensures that these services are secure and trustworthy. It lays the foundation for Europe’s digital future. 2. Key Objectives and Innovations Introduced by the NIS2 Regulation The NIS2 regulation is a true revolution in the world of cybersecurity. Its main goals are ambitious and far-reaching, aiming to create a unified, strong digital protection system across the European Union—like building a digital fortress for the continent. One of the key objectives of the NIS2 regulation is to harmonize regulations. Imagine that each EU country has a different lock on their digital fortress. NIS2 provides everyone with the same, state-of-the-art lock, facilitating cooperation and strengthening our collective defense. NIS2 also emphasizes enhancing resilience to cyberattacks, akin to training our digital muscles. The stronger we are, the harder we are to defeat. The regulation requires companies to continually improve their defensive systems, ensuring a robust defense against potential cyber threats. 2.1 Strengthening the Security of Networks and Information Systems in Key Sectors The NIS2 regulation focuses on protecting key economic sectors, akin to erecting the strongest walls around the most crucial buildings in a city. NIS2 encompasses sectors such as energy, transportation, and healthcare, which are vital for the functioning of society. NIS2 introduces more stringent security standards for these sectors, similar to replacing standard locks with advanced biometric systems. Companies are now required to employ the latest technologies and practices in cybersecurity. The regulation also mandates regular audits and security tests, like constantly checking if our digital walls are strong enough. This allows us to detect and fix vulnerabilities before they can be exploited by cybercriminals. 2.2 Expanding the Scope of Risk Management and Incident Reporting Duties The NIS2 regulation significantly broadens the responsibilities of companies in risk management, likening it to assigning each employee the role of a guard in a digital fortress. Companies must now actively identify and minimize potential threats. NIS2 also introduces more rigorous requirements for incident reporting, akin to an alarm system that immediately notifies everyone of a breach. Companies must quickly report serious security incidents to the appropriate authorities. The new rules also require greater transparency. Companies must inform their customers about serious threats, which builds trust and enables better protection for everyone. The NIS2 regulation fosters a culture of openness in cybersecurity matters. 3. Who Will Be Subject to the New Regulations? Analyzing the Criteria for Inclusion Under the Directive The question “Who does NIS 2 apply to?” is a key issue for many companies. The NIS 2 Directive significantly expands the range of entities covered by the regulations, like extending the boundaries of the digital city we must protect. The new rules encompass a broader spectrum of sectors and organizations than the previous version. NIS 2 primarily affects companies and institutions deemed essential for the functioning of the economy and society. It’s like marking strategic points on a map that require special protection, including sectors such as energy, transportation, banking, and healthcare. But NIS 2 goes further. It also includes companies considered “important.” This extends the safety net to additional areas of our digital ecosystem. Service providers, electronic equipment manufacturers, and companies in the food sector—all may find themselves under the umbrella of NIS 2. 3.1 Definition of Key and Important Entities – What Changes? NIS 2 introduces new definitions for key and important entities, akin to a new classification of buildings in our digital city. Key entities are those whose operations are essential for society’s functioning. A failure here could have catastrophic consequences. Important entities are companies whose role is significant but not critical, like shops or restaurants in our digital city. Their security is important, but not as crucial as hospitals or power plants. NIS 2 imposes less stringent requirements on them than on key entities. What changes? NIS 2 expands the list of sectors considered key or important. Now it includes food production and distribution, waste management, and the space sector. It’s like adding new districts to our digital city that we need to protect. 3.2 The Significance of the Directive for Small and Medium Enterprises (SMEs) and Their Special Role in the Cybersecurity Ecosystem NIS 2 is of immense significance for small and medium enterprises (SMEs). It’s like paying attention to the smaller buildings in our digital city. SMEs are often overlooked in discussions about cybersecurity, but NIS 2 changes this narrative. The directive recognizes the special role of SMEs in the cybersecurity ecosystem. It’s acknowledging that small shops are as vital to the city as large shopping centers. SMEs are frequent targets of cyberattacks, and their security impacts the entire network of business connections. NIS 2 introduces special provisions for SMEs, like creating dedicated protection programs for smaller firms. The directive requires member states to provide support and resources to SMEs to help them meet new security requirements. At the same time, NIS 2 acknowledges the limitations of SMEs. It introduces proportional requirements that consider their capabilities, like tailoring the alarm system to the size of the building. SMEs must enhance their security but in a manner that is adequate to their scale of operations. 4. Practical Aspects of Implementing NIS2 in Organizations Implementing NIS2 is a formidable challenge for many companies, akin to renovating an entire building while the business must continue to operate uninterrupted. NIS2’s requirements are comprehensive and touch upon many aspects of organizational activities, making a strategic approach to their implementation crucial. Companies must understand that NIS2 is not a one-time task but a continuous process, like introducing a new culture of safety within the organization. It requires the commitment of all employees, from the executive board to rank-and-file workers, each playing a role in building the digital fortress. 4.1 How to Prepare Your Business for Compliance with NIS2: An Action Plan Current State Audit: Start by assessing the current level of cybersecurity, akin to doing an inventory before a renovation. Identify gaps and areas needing improvement. Gap Analysis: Compare the current state with NIS2 requirements to understand the scope of work ahead. Create a list of specific actions to be taken. Prioritization of Actions: Not everything can be done at once. Set priorities, starting with the most important and urgent issues. Budgeting: NIS2 requirements may be associated with costs. Plan a budget for necessary investments in hardware, software, and training. Employee Training: Education is key. Plan regular cybersecurity training for all employees. Updating Policies and Procedures: Adjust internal regulations to meet NIS2 requirements, like writing new rules for residents of the digital city. Testing and Audits: Regularly check the effectiveness of implemented solutions, like trial alarms in a building. Continuous Improvement: NIS2 is an ongoing process. Be prepared for regular updates and improvements to the security system. 4.2 Major Challenges and Pitfalls in Implementing the Requirements—How to Avoid Them? Implementing NIS2 requirements comes with certain pitfalls. Here are the most common challenges and ways to avoid them: Underestimating the Scale of Change: NIS2 represents a comprehensive overhaul. Do not treat it as a minor update. Plan time and resources commensurate with the scale of the challenge. Focusing Only on Technology: NIS2 is not just an IT issue; it’s an organizational change. Involve all departments in the implementation rocess. Ignoring the Culture of Safety: The best systems won’t help if employees don’t understand them. Invest in education and building awareness. Lack of Continuity: NIS2 requirements are not a one-time task. Create a system for continuous monitoring and improvement. Starting Too Late: Don’t wait until the last minute. Begin preparations as early as possible to allow time for thorough implementation. Ignoring the Supply Chain: NIS2 also includes business partners. Ensure that your suppliers also meet the requirements. Lack of Flexibility: Cyber threats evolve. Your security system must be ready to change. Be flexible and ready to adapt. By avoiding these pitfalls, you can smoothly implement NIS2 requirements. Remember, this is an investment in the security and future of your business, like building a solid foundation for future development in the digital world. 5. Sanctions for Non-compliance and Support for Organizations in Adapting to NIS2 NIS2 not only sets forth requirements but also a system of penalties and incentives, much like a traffic code for the digital highway. Adhering to the rules is crucial for the safety of all. At the same time, NIS2 offers support for companies that want to comply, creating a balance between stick and carrot. 5.1 Overview of Potential Penalties for Non-compliance NIS2 introduces severe penalties for non-compliance, akin to fines for traffic violations but much more serious. The penalties are designed to be an effective deterrent against disregarding cybersecurity. Here are the main types of sanctions: Financial Penalties: NIS2 stipulates fines up to 10 million euros or 2% of a company’s annual turnover. These significant amounts can have a serious impact on an organization’s finances. Administrative Orders: Regulatory bodies can require companies to undertake specific corrective actions, similar to ordering the repair of a faulty brake system in a car. Public Warnings: In some cases, authorities may publicly announce that a company does not meet NIS2 requirements, which can seriously damage the organization’s reputation. Temporary Suspension of Operations: In extreme cases, a temporary halt of a company’s operations is possible, akin to revoking a driver’s license for serious offenses. Personal Liability of Executives: NIS2 can hold board members accountable for serious neglect, adding extra motivation for leaders to prioritize cybersecurity. 6. Face cyber security challenges with Transition Technologies MS We invite you to collaborate with Transition Technologies MS to achieve the highest security standards that not only meet but exceed the requirements of NIS2. Our team of experts is ready to support your organization at every stage of the process, providing peace of mind and the necessary protection in today’s rapidly changing digital world. Please contact us to obtain detailed information about our service offerings. If you need any support with NIS 2 contact us now!

Serialization of Medicines: An Effective Tool in the Fight Against Frauds in the Pharmaceutical Market

The entire world recognizes the risks associated with using medicines of unknown origin. Numerous studies indicate a significant percentage of counterfeit medicines reaching patients. Patients often unknowingly acquire these products on auction platforms, various “markets,” from acquaintances, or even at pharmacies. While trading products outside of state control can only be limited through education and a firm stance by authorities, counterfeit medicines that reach pharmacies are more challenging to detect, posing a serious threat. 1. Why is medicine serialization important? Medicine serialization is the process of assigning each package of medicine an individual serial number, which is monitored at various stages of the supply chain. Thanks to unique serial numbers, it becomes easier to identify genuine products, helping to eliminate fake medicines and protect patients from harmful or ineffective substances. The serialization process allows tracking of each package of medicine from the moment of production to delivery to the patient. This enables a rapid response in case a defective batch needs to be withdrawn from the market. It’s worth noting that in many countries, such as EU member states (in line with the Falsified Medicines Directive) or the USA (DSCSA law), serialization is mandatory to enhance the safety of pharmaceutical products. Moreover, this system allows for more efficient management of drug inventories and control over their distribution, reducing the risk of errors, such as duplicate batches or improper handling of controlled medicines. There have been several prominent incidents in pharmaceutical history that exposed the problem of lacking adequate control mechanisms, such as serialization. In the 1930s in the USA, mass poisonings with “Elixir Sulfanilamide,” containing toxic diethylene glycol, led to the deaths of over 100 people, including children. The lack of regulation and control mechanisms like serialization contributed to this tragedy, which led to stricter laws being introduced (the Food, Drug, and Cosmetic Act, 1938). Thalidomide, used in the 1950s and 1960s as an anti-nausea medication for pregnant women, caused deformities in thousands of children. The lack of appropriate monitoring and serialization systems prevented a quick response and effective recall of the drug from circulation. In Nigeria, in the mid-1990s, fake antimalarial medicines flooded the market, leading to numerous deaths and health complications among people who unknowingly took ineffective or toxic substitutes. Unfortunately, this is not the only counterfeiting scandal remembered in Africa’s pharmaceutical history. In various African countries between 2000-2010, counterfeit antimalarial medicines, such as artemisinin, were widely distributed, leading to thousands of deaths due to ineffective treatment. None of the packages of the mentioned medicine had a serial number. While it may seem that the aforementioned pharmaceutical crimes took place long ago or do not concern the Western world, the case of contaminated heparin in 2007 feels much closer. Heparin is a commonly used blood thinner. Batches of this drug contaminated with chondroitin sulfate were previously produced in China and then imported into the USA, where they entered circulation, leading to hundreds of complications and 81 deaths. The lack of effective mechanisms for identifying individual product batches, such as serialization, made it difficult for authorities to swiftly withdraw the dangerous mediciness from the market. The problem was discovered only at the beginning of 2008 when a series of unexpected complications and deaths were reported in patients undergoing medical procedures in hospitals where heparin was administered. The heparin scandal clearly showed the importance of monitoring the medicine supply chain, especially in a global economy. Medicine serialization, which was later introduced as a standard in many countries, aimed to prevent similar scandals by allowing each package of medicine to be tracked from production to the patient, significantly enhancing safety. All these cases demonstrate how crucial it is to maintain thorough control over medicines and to be able to track them. The serialization of medicinal products is one of the tools that can help prevent such tragic incidents, ensuring patient safety and effective product recall from the market. 2. Verification through Unique Identifiers To combat counterfeit drugs, the obligation to verify the authenticity of medicines through serialization has been introduced. Medicineverification through unique identifiers is a key component of the system designed to prevent the falsification of pharmaceutical products. This process involves assigning each package of medicine a unique batch number (LOT), which is tracked at various stages of distribution. Each medicine box receives a unique identifier, which typically consists of: Global Trade Item Number (GTIN) – assigned to the pharmaceutical product, Serial Number (SN/NS) – unique for each package, Batch Number (LOT) – indicating the production batch, Expiry Date (EXP) – specifying the drug’s shelf life. All these details for a given batch of medicine are stored in the form of a 2D barcode (e.g., DataMatrix) or a QR code, which is placed on the medicine’s packaging. Verification of authenticity is done by scanning the code on the packaging, which is checked against a central database accessible to manufacturers, wholesalers, pharmacies, and relevant regulatory authorities. This system of medicine authenticity verification enables the checking of the origin of mediciness before they are dispensed to patients, as well as tracking each package of medicine throughout the entire supply chain. 3. Application of Advanced Information Technologies The online medicine verification system utilizes advanced information technologies, enabling effective verification and identification of medicines. The serialization process requires generating unique codes and printing them on the packaging. An important element is also print verification, which involves checking whether the medicine codes are readable and contain correct information. Image recognition techniques and large-scale data processing are used for this purpose. It is also worth mentioning that the use of advanced IT technologies, such as blockchain, cloud computing, IoT, AI, and Big Data, significantly increases the security and transparency of medicine verification. Blockchain is one of the newest medicine verification technologies, ensuring complete transparency and immutability of records. In blockchain, every transaction related to the medicine – from production, through distribution, to sale – is recorded as a block in the chain, which is publicly accessible and cryptographically secured. Cloud systems allow quick access to medicine-related data from anywhere in the world and integration of global systems (facilitating easy connection between different pharmaceutical supervision systems, enabling international cooperation). Big Data, or the analysis of large data sets, allows the identification of patterns, trends, and anomalies in the medicinesupply chain. By analyzing huge amounts of data on distribution, sales, and market monitoring, it is possible to detect irregularities early that suggest the presence of counterfeit medicines. IoT technology, in turn, enables communication between devices over the Internet. It can be used to monitor medicines at every stage of their journey. Drugs, especially those requiring special conditions (e.g., low temperature), are equipped with IoT sensors that monitor temperature, humidity, and other parameters during transport and storage. If storage conditions are exceeded, the IoT system automatically sends alerts to relevant personnel, allowing for immediate action and the withdrawal of drugs from circulation. AI and machine learning are increasingly used to analyze drug-related data and predict risks associated with counterfeiting. AI can predict potential counterfeiting threats by analyzing historical data and behaviors in the supply chain. AI systems can automatically analyze serialization data and report suspicious cases or deviations from the norm. The introduction of mobile applications allows patients and pharmacists to quickly verify the authenticity of drugs. Users can scan the 2D barcode on the medicine’s packaging using a smartphone and instantly check whether the drug is genuine, as well as obtain information about its origin, manufacturer, and expiration date. Examples: Mobile applications can alert patients if a counterfeit drug is detected, as well as allow for reporting suspicious products to regulatory authorities. RFID technology enables wireless identification of products using radio waves. Thanks to RFID chips, it is possible to monitor in real time where a particular drug is and whether it has reached the correct facility. 4. System Integration and Central Database Drug manufacturers must integrate new systems with existing ones or develop new solutions to enable the serialization process. System integration involves connecting various tools and technologies used by different entities in the drug supply chain, such as manufacturers, wholesalers, pharmacies, and regulatory bodies, into a single cohesive system. The goal of integration is to ensure smooth information exchange between these entities, enabling comprehensive monitoring and verification of medicines at every stage of their journey, from production to delivery to the patient. Each packaging line in the factory must be equipped with appropriate interfaces, printers, cameras, and computers to manage the drug serialization process. The central drug database is a centralized platform that collects and manages information about all medicines subject to serialization and monitoring. This database is a key element of the verification system, as it enables the storage of data on every package of medicine or medicinal product and its distribution history. An example of such a database in Europe is the European Medicines Verification System (EMVS), which allows drug verification in accordance with the requirements of the Falsified Medicines Directive (FMD). In the USA, this role is fulfilled by the Drug Supply Chain Security Act (DSCSA), which envisions the creation of a similar monitoring system. The central drug database forms the foundation of verification systems, providing full control over the authenticity and origin of drugs, preventing counterfeiting, and increasing patient safety. Furthermore, the costs associated with adding a drug to the central drug database are usually borne by the drug manufacturer. Through system integration and the collection and submission of codes from properly packaged products, effective verification of drug authenticity is possible at every stage of distribution. 5. Impact of Serialization on Pharmaceutical Infrastructure The implementation of the serialization process has had a significant impact on the pharmaceutical infrastructure and industry. This legal requirement has resulted in positive changes for the entire industry. First and foremost, every entity involved in the production and distribution of a drug must adapt production, distribution, monitoring, and data management processes. This affects all entities in the supply chain, from manufacturers to wholesalers to pharmacies. Every pharmacy has been equipped with terminals for verifying packages, allowing them to check the authenticity of drugs before dispensing them to patients. Moreover, the introduction of the serialization process required coordination among manufacturers, pharmacies, and other entities involved in the process. This certainly increased drug safety. However, ensuring compliance with global regulations has raised production costs. In many countries, serialization is required by law (e.g., in the European Union under the Falsified Medicines Directive – FMD, and in the USA under the DSCSA), meaning companies must adapt their infrastructure to meet these requirements. In Poland, the National Medicines Verification Organization (KOWAL) was tasked with overseeing and coordinating the implementation of the serialization process. Drug serialization forced pharmaceutical manufacturers to adapt to new regulations, which involved additional costs. Although this may seem challenging, the significant benefits of this process cannot be overlooked. One of the key advantages is the improvement of quality management, which these regulations enforce on manufacturers, ensuring a higher level of product control and increased patient safety. Serialization allows companies to better manage drug quality by monitoring the entire product lifecycle. This not only leads to improved quality and safety but also helps optimize costs and produce with greater respect for the natural environment. 6. Benefits of Serialization for Patients and the Pharmaceutical System The introduction of the serialization process for medicinal products has brought numerous benefits for patients and the entire pharmaceutical system. Most importantly, it has enabled the effective identification of genuine medicines and the detection of counterfeits, increased transparency (greater transparency in drug distribution has contributed to a better perception of the pharmaceutical system), as well as improved inventory management. Patients can have greater confidence that they are receiving safe and effective products rather than counterfeit drugs. Drug serialization also helps combat the gray market and the illegal trade of counterfeit medicines, contributing to the protection of public health. Additionally, improved control over drug distribution can help reduce treatment costs associated with the misuse of counterfeit or ineffective products. Serialization also helps protect patients from expired medications, as the system allows tracking of the expiration date of medicines at every stage of distribution. Patients only receive medications that fully comply with current quality standards and are not expired. 7. Medicine Serialization – Summary In summary, the introduction of the serialization process in pharmacy was an essential tool in the fight against counterfeit medicines, which simultaneously ensured safe and authentic products for patients. The use of advanced information technologies enabled effective drug verification and identification, as well as control over the distribution process. The benefits for patients, manufacturers, and the entire pharmaceutical system are evident, marking an important step towards ensuring the safety and authenticity of drugs on the market. In this fight against counterfeits, we are proud to be a provider of quality management solutions for the pharmaceutical industry. Acting as experts at TTMS in the field of drug serialization, we offer comprehensive services and consulting to help fully implement the serialization process. Our experienced team of specialists has the knowledge and skills to support you at every stage, from planning to implementation and maintenance. If you need support in implementing appropriate systems tailored to your needs, TTMS Quality is here to help. Our experts can provide not only technical solutions but also business consulting services. Contact us to learn more about our services and how we can assist you in implementing the serialization process. Together, we can ensure drug safety and authentic products for patients. We will support you in achieving success in the pharmaceutical industry.

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