GMP Publications - Code of Federal Regulation Handbooks by the FDA

Electronic Systems Master Handbook 1

GXP-ElectronicSysMasterHandbook-1.jpg
978-1-935131-15-1

US FDA Title 21 CFR Parts

Part 11 - Electronic Records with Scope and Application 2003
Computerized Systems Used In Clinical Investigations 2007

European Union (EU) Annexes

Annex 11 - Computerized Systems
Annex 15 - Qualification and Validation

GMP Publications Audit Check Lists

The Auditing Group Part 11 Check List for Computerized Systems



















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