A Basic Overview: Meeting the PIC/S Requirements for a Computerized System

October 6, 2016

This whitepaper provides a summary of the impact of PIC/S, and compliance with the PIC/S document PE 009-12 “Guide to Good Manufacturing Practice for Medicinal Products Annexes“ Annex 11 Computerised Systems. It includes a high-level foundation to understand how pharmaceutical manufacturing companies are being regulated, what PIC/S means for common requirements across different countries, and how these requirements relate to expectations for data from computerised systems/electronic records.