• gmp-verlag.de
  • GMP MANUAL Login
  • Shopping cart
Shopping cart
Your shopping cart is empty

Show shopping cart...
Stay informed!

If you’d like to be regularly informed on the latest developments in Good Manufacturing Practices


>>> REGISTER for our free GMP Newsletter LOGFILE

Qualification / Validation

Documenting Process Validation
A Drugmaker‘s Guide

Here’s a step-by-step manual based on real-world examination experience. You’ll discover how to document process validation in a way that’s sure to satisfy — and impress — regulators.

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

Page 1/1    1