CSV Services – Computer Systems Validation from Experts
Gain a technological leadership edge with our expertise in Computer Systems Validation Services
Comprehensive CSV Audit Services – Upgrade Your Company’s Standards with Our Professional Services
TTMS offers a comprehensive IT system CSV Services. With our Experts, you can be sure that your system, tool, or process meets the criteria associated with its use and regulatory compliance requirements.
We are a trusted partner in Computer Systems Validation Services for industries like
We are a highly specialized IT Company providing Software and Laboratory CSV Services in the Pharmaceutical Industry
TTMS S.A. has many years of experience in the validation sector for pharmaceuticals, making it a trusted partner in the pharmaceutical industry. The CSV service process in this sector begins at the concept stage of a computer system and continues throughout its entire lifecycle.
It encompasses all key phases, such as design, implementation, operational use, and system decommissioning. In the pharmaceutical industry, validation is crucial and must be completed before the IT system is implemented. Although validation can also be realized for a system in the operational phase, the recommended time to conduct it is during the system construction and implementation phase.
However, the process does not end at this stage – a validated system requires continuous control, management of changes, incidents, access, and users, as well as provision of technical support and recovery.
Thanks to TTMS extensive experience in computer systems validation, our customers can be assured that their systems comply with the highest standards and meet all regulatory requirements.
CSV Audit Services for the Pharmaceutical Industry According to GAMP 5 Standards
Validation of information systems is a process consisting of specific, planned activities that must be carried out in carefully planned stages. The design of validation should include the timing of its implementation. Thus, one must consider whether it is carried out during the design, implementation, or use of the system. Equally important is whether the software was purchased from an external supplier or developed and created internally by the company.
The TTMS Quality team offers comprehensive computer system validation services following the highest industry standards, such as Annex 11 of the GMP Regulations and the GAMP 5 guide. Our approach covers all key steps in the CSV process to ensure full regulatory compliance and maintenance of the highest operational quality. Every process and system functions like a living organism, which means they need continuous monitoring and regular check-ups to ensure they perform at their best. Therefore, we provide CSV Audit Services to assess and verify the effectiveness and compliance of your validation processes.
Our audit services involve a thorough evaluation of your existing validation processes, identifying any potential gaps or areas for improvement. We provide detailed reports and actionable recommendations to help you maintain compliance, reduce risk, and optimize your system’s performance. With our expert support, you can be confident that all validation efforts align with the latest regulatory expectations and operational excellence.
Our areas of expertise include:
Validation plan development
We develop a clear validation plan that sets the groundwork for the entire process, making sure all requirements are clearly outlined and meet the necessary standards.
Design specification and review
We conduct a thorough requirements specification and design review to ensure that the system meets all operational and quality criteria.
Develop and execute test plans
We create and execute detailed test plans, including unit tests (UT), integration tests (IT), acceptance tests (UAT), and system tests (SAT), to verify the functionality and reliability of the system.
Results review and reporting
Once the tests are completed, we thoroughly analyze the results, producing reports that document the system’s compliance with established requirements.
Validation of information systems in the Computer Software Assurance (CSA) approach
TTMS Quality is adopting an innovative approach to validation known as Computer Software Assurance (CSA). This solution, gaining popularity, focuses on risk based system testing and critical thinking, reducing the emphasis on traditional documentation.
With this approach, the focus is on:
Assessing the impact of software on patient safety.
Analyzing the impact on product quality.
Ensuring system integrity within your Enterprise.
Our innovative methods allow you to manage your risks more effectively while ensuring the highest levels of safety and quality. When you choose TTMS Quality, you get a partner who will ensure that your Organization’s systems are fully compliant with the most demanding standards.
Ready to take your business to the next level?
Let’s talk about how TTMS can help.
