GAMP5 is pretty clear in its ambition: This Guide applies to computerized systems used in regulated activities covered by: •Good Manufacturing Practice (GMP) (pharmaceutical, including Active Pharmaceutical Ingredient (API), veterinary, and blood) •Good Clinical Practice (GCP) •Good Laboratory Practice (GLP)•Good Distribution Practice (GDP) •Good Pharmacovigilance Practices (GVP) •Medical Device Regulations (where applicable and appropriate, e.g., … Continue reading GAMP’s Biggest Problem is the Name