Benefit from the experience of Testo Industrial Services: We validate systems in the Pharmaceutical industry and the Medical technology. In accordance with GMP requirements, the suitability of a computerised system must be demonstrated in these areas.
The Computer System Validation and Software Validation (CSV) ensure that procedures, processes or operations of computer-based systems reproducibly lead to the desired results. Our experts support you in the validation of your computer and software systems requirements in the pharmaceutical industry and medical technology. Together with you, we create a software matrix and determine the validation relevance of the software used in your company. Finally, the validation of your systems is carried out according to a risk-based validation approach in accordance with the requirements of GAMP 5.
Pragmatic and risk-based validation approach
We recommend that you define a pragmatic validation approach and that you use the following methods during the Validation practice-oriented and risk-based. As a general rule, software used as part of a quality management system must be validated. Examples are software systems for document, change or deviation management as well as for test equipment management or the control of monitoring systems.
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