The huge development of computer system within pharmaceutical and medical device sector has a tremendous impact on quality system due to the necessity to perform extensive software validation; for this reason here we provide an example of Computer System Validation Procedure. In the version 2016 of ISO 13845, it is clearly mentioned that all the SW used within the Quality System
Nowadays software validation has become an essential activity within the Quality System and a lot of attention is given by competent authorities on this topic.
The Computer System Validation procedure described the methodology used for software validation, which is based on GAMP5 guideline. GAMP stays for Good automated manufacturing practice and the full name of the guideline is GAMP 5 Guide: Compliant GxP Computerized Systems. The guideline provides extensive guideline on the validation of software using a risk-based approach.
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