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GMP Computer Validation

Computer System Validation in the EU
a step-by-step guide to implementing a computer validation program that will satisfy U.S. and EU regulations

 
 
Computer Validation
GMP Pocket Guide Volume 2
- 21 CFR Part 11 Electronic Records, Electronic Signature
- PIC/S PI 011 Good Practices for Computerised Systems in Regulated ”GxP“ Environments
- EU-GMP-Guideline Annex 11 Computerised Systems

 
 
Computer Infrastructure Qualification For FDA Regulated Industries
This book provides practical information to enable compliance with computer infrastructure requirements including the verification activities related with the design and deployment.

 
 
 
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