GAMP-5 Mastery: Essential Guide to Computer System Validation for Regulated Industries
GAMP-5 guidance, the related “V model” and the different software categories used to simplify the validation activities are nowadays considered the internationally recognised best approach for computer system validation. GAMP stays for “Good Automated Manufacturing Practice” and it is a guideline which is published by the ISPE, International Society for Pharmaceutical Engineering. The guideline is…