Professional Equipment Qualification and Production System Validation Services
Achieve a higher level of operational efficiency and manufacturing quality with equipment qualification and process validation.
Comprehensive Qualification and Validation for Demanding Industries
TTMS provides equipment and process qualification and validation services for the pharmaceutical industry (including laboratory equipment qualification), biotechnology, logistics, and other sectors where quality and regulatory compliance are essential.
Process Validation – 4 Steps to Success
Equipment Qualification (EQ) confirms that devices used in production, quality control, and other operations perform as expected and meet regulatory and technical specification requirements. Validation is a documented process that provides companies with a high level of confidence that their processes, methods, or systems will consistently deliver results meeting established acceptance criteria.
The team of experienced TTMS experts ensures the highest quality of process validation services, following these key steps:
(DQ – Design Qualification)
We conduct evaluations and prepare documentation to ensure the process meets all requirements for its intended use.
(IQ – Installation Qualification)
This step includes activities to confirm that equipment and/or systems have been correctly installed in accordance with the design and manufacturer’s specifications.
(OQ – Operational Qualification)
At this stage, we test equipment, systems, and/or processes to verify that they operate as intended under the conditions they will encounter during normal operations.
(PQ – Performance Qualification)
During this phase, our experts ensure that the equipment, system, and/or process operates efficiently and consistently during production, meeting all quality requirements.
Equipment Qualification and Process Validation – Ensuring GMP Compliance in Your Company
Validation provides a high level of assurance that your production processes will consistently deliver products of the highest and expected quality. Our experts support companies at every stage of this process, including ongoing validation, to ensure continuous compliance and excellence.
Equipment qualification and process validation are critical elements that not only guarantee the high quality and safety of products but also ensure full compliance with legal regulations such as GMP (Good Manufacturing Practice) or ISO standards.
Why Should You Invest in Equipment and Process Qualification?
Ensuring Product Safety and Effectiveness
With carefully qualified equipment and validated processes, your company can ensure that products are manufactured under controlled conditions, minimizing the risk of production defects.
Regulatory
Compliance
Industries such as pharmaceuticals, medical devices, food, and cosmetics are subject to strict regulations. Equipment qualification and process validation ensure that your company meets the requirements of audits and inspections.
Process
Optimization
Validation helps identify and resolve potential issues, leading to more efficient and cost-effective production processes.
Trust an Expert Team for Your Equipment Qualification and Process Validation Needs
Our team consists of highly skilled professionals specializing in equipment qualification and process validation. With deep expertise and years of experience, we have delivered exceptional services to top companies in the pharmaceutical, biotechnology, medical devices, cosmetics, and food industries worldwide.
The TTMS Quality team provides end-to-end solutions in equipment qualification and process validation, guaranteeing full adherence to industry standards and regulatory requirements.
Explore Our Additional Expertise to Enhance Equipment Qualification, Process, and System Validation Services
CHANGE MANAGEMENT
We develop change management procedures to ensure that any future modifications to qualified equipment or validated processes are properly assessed and implemented in accordance with regulations and standards.
QUALIFICATION/VALIDATION PLANNING
As part of our equipment qualification (production or laboratory) and process validation services, we create qualification and/or validation plans methodically and in alignment with industry guidelines. This guarantees that your processes and equipment meet all required quality and safety standards.
PERIODIC REVIEWS
Requalification and revalidation in the context of equipment qualification and process validation are essential to maintain ongoing compliance with quality and regulatory requirements following the initial qualification or validation.
PERSONNEL TRAINING
We provide personnel training in equipment qualification and process validation. This ensures that all employees involved in qualification and validation processes have the necessary knowledge and skills to effectively carry out and support these activities.
FAQ
What is the Purpose and Scope of Qualification and Validation?
The purpose of conducting equipment qualification and/or process or computerized system validation is to ensure compliance with regulations and maintain the quality of manufactured products.
Qualification applies to equipment, installations, systems, and devices, whether newly installed or modified.
Validation applies to processes and computerized systems.
What Does a Step-by-Step Validation Plan Look Like?
First, in consultation with the client, we create a detailed description of the system or process. This includes the equipment and/or processes to be validated. Next, we define the criteria that must be met for the validation to be deemed successful and proceed to develop an action schedule, assigning responsibilities to appropriate individuals or teams. We then identify the resources needed for the validation process, including personnel, time, and equipment. Finally, we assess potential risks associated with the validation process and prepare a mitigation plan to address those risks.
What Does Qualification and Validation Documentation Include?
The qualification report is a document used to record the results of each phase of the validation process. It includes detailed information about the tests conducted, acceptance criteria, obtained results, and any deviations that may have occurred. Once the validation process is complete, a validation report is prepared, containing conclusions from the tests, documentation of results, and confirmation of whether the validation process was successfully concluded.
Why Are Reviews Important for Equipment Qualification and Process Validation?
Reviews provide periodic, formal assessments that result in a comprehensive analysis of equipment and process performance over time. This allows for the quick implementation of potential improvements.
Why Is Staff Training in Equipment Qualification and Process Validation Important?
Training staff in the context of equipment qualification and process validation is a critical step to ensure that all employees involved have the necessary knowledge and skills to properly perform qualifications and maintain equipment according to regulatory and quality standards. Training includes both theoretical foundations and practical exercises and is regularly updated and documented.
How Are Training Needs Identified for Equipment Qualification and/or Process Validation?
We begin by assessing roles and responsibilities to identify which positions and functions in the organization will be involved in the equipment qualification and/or process validation process. This process may involve various groups of employees, such as machine operators, engineers, maintenance personnel, quality specialists, and auditors. Each group may require different levels of training based on their responsibilities. Based on this analysis, the training scope is defined and tailored to the specific needs of each group. For some employees, technical details regarding equipment operation may be the priority, while others may need to focus on control procedures, documentation, or data management.
What Does Staff Training in Equipment Qualification and Process Validation Entail?
Training typically begins with an introduction to the theory and regulatory requirements, such as GMP (Good Manufacturing Practices) and industry standards like ISO. It then covers the specific components of validation, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Practical exercises are a crucial part of the training, allowing employees to participate in simulations of real-world activities, such as installation, operational testing, and performance evaluation of equipment.
What Does Practical Training for Equipment Qualification and Process Validation Look Like?
Employees are often trained directly on the equipment being qualified, helping them better understand the specific challenges associated with its operation, testing, and documentation. This training may also include simulations of failures or deviations in equipment performance, teaching staff how to respond quickly and effectively to problems and perform appropriate corrective actions. Additionally, personnel are trained in the proper maintenance and storage of qualification and validation documentation, which is essential for passing audits and inspections.
How Can You Assess the Effectiveness of Training?
After completing theoretical and practical training, employees undergo tests to evaluate their knowledge of equipment qualification and related procedures. Their skills are then assessed through practical tasks where they must demonstrate their ability to properly perform activities such as equipment installation and testing in compliance with established procedures.
Is One Training Session Enough to Prepare Staff for Equipment Qualification and Process Validation?
Supplementary training should be organized regularly to help staff adapt their knowledge and skills to changes, such as new technologies, updated regulations, or the introduction of new equipment. Ongoing employee education can be reinforced through workshops, informational sessions, and access to online educational materials, ensuring continuous improvement in their competencies.
Ready to take your business to the next level?
Let’s talk about how TTMS can help.
