21 CFR Part 11 — Electronic Records; Electronic Sigantures
Beyond Compliance — Beyond Compliance - Product Quality and Organizational Compliance
General Principles of Software Validation — General Principles of Software Validation; Final Guidance for Industry and FDA Staff
Glossary of Computer Systems Software Development Terminology (8/95) — Glossary of Computer Systems Software Development Terminology (8/95)
Introduction and support package: Guidance on the documentation requirements of ISO 9001:2008
ISO Quality Management Prinicples
Validation Plan Template — ISPE (International Society for Pharmaceutical Engineering) equipment validation plan template. (Clicking VIEW will DOWNLOAD the file.)