About this document
GxP Documentation and CSV Best Practices by Divyendu Das is a document available to read on EtoBox.
This document discusses good documentation practices for computer system validation and GxP systems. It defines key terms like computer system validation (CSV), CFR Part 11, and GxP. CSV involves evaluating and documenting system components throughout development to ensure accuracy, reliability and security. Good documentation practices require uniquely identifying documents, tracking changes, maintaining revision history, and collecting objective evidence of tests. Handwritten changes must be dated, initia
- Author
- Divyendu Das
- Language
- EN