Process validation
Process validation ensures high product quality throughout the entire life cycle. Depending on your needs, our GxP Services team can take over individual tests or the complete handling of your validation projects for you.
The regulatory requirements determine the scope of validation and demand continuous process verification according to the "life cycle approach". Testo Industrial Services supports you with experience and expert knowledge in meeting compliance requirements in the pharmaceutical industry and medical technology.
Create safe process results
Risk based validation provides evidence that a process meets the requirements for its process results. Our GxP Services Team secures your process results together with you and individually according to your needs. The foundation of our validation services is an effective risk management in accordance with ICH Q9, for which our experts are also available to advise you.
Our service for you:
Holistic handling of your cleaning validation:
- Support from planning to production
- Structuring of process validation based on current guidelines (e.g. FDA Guidance for Industry)
- Carrying out in-process and end product control
- Accompaniment of optimisation studies
- We share our practical Expert knowledge and know-how with you
Medical Technology Services
Safety and compliance in medical technology
We also implement your quality assurance measures in the areas of calibration, qualification, validation and compliance in a pragmatic, cost-sensitive and effective manner in the medical technology environment.
Your advantage: Our competence
- Expertise: Consulting, measurements, project management - our industry experienced team supports you precisely & in line with your needs
- Technology: The use of our measuring equipment with more than 4,500 references ensures reliable measurement and test results
- Documentation: The documentation in the audit-proven layout or individually according to customer requirements will be handed over to you personally upon completion of the order
GxP-Services-Team
Professional competence, experience and high-precision equipment. The engineers and technicians of our GxP-Services Team are at your service throughout Europe.
Success stories
We support you in your projects and are committed to your goals. Here you will find an excerpt from the references of our successful projects in the area of process validation. At B. Braun Medical AG, we created a cross-site concept to increase GMP compliance, including the pragmatic integration of existing documentation into the new GMP concept. Consulting, structuring and implementation of comprehensive activities in the compliance areas of qualification, process validation, cleaning validation and validation of analytical methods were taken over by us in this project.
Know-how
In addition, you will find answers from our experts to numerous questions from our specialist areas in our Knowledge Centre.
