Siedlerstraße 7 | 68623 Lampertheim, Germany

info@zamann-pharma.com

This article explains computerized system validation in regulated environments, focusing on CSV life cycle controls, data integrity compliance, and risk-based validation principles. It also highlights inspection expectations, supplier assessment guidance, and audit trail requirements under FDA Part 11 and EU
GAMP is the acronym used to summarize the term “Good Automated Manufacturing Practices“. These are a compilation of recommendations published by the International Society for Pharmaceutical Engineering (ISPE) in the form of a book to provide guidance on the compliance