Validation Center™

Regulations affecting computer systems in the life sciences are spread over many different organizations and websites.  Here you can access all the software compliance regulations and guidance information you need from the U.S. and Europe in one spot.

Resources:

Title	Category
EMEA Procedure For Conduction GCP Inspections Requested by the EMEA: Computer Systems	Regulations and Guidance EMEA
Eudralex V10 Ch IV Annex III: Guidelines for the Conduct of GCP Inspections - Computerised Systems	Regulations and Guidance European Commission
Eudralex V10 Ch IV: Guidelines for the Conduct of GCP Inspections	Regulations and Guidance European Commission
Eudralex V4 Annex 11: GMP Guidelines for Computerised Systems	European Commission Regulations and Guidance
Eudralex V4 Annex 11: GMP Guidelines for Computerised Systems (new draft)	European Commission Regulations and Guidance
Eudralex V4 Annex 15: GMP Guidelines for Qualification and Validation	European Commission Regulations and Guidance
Eudralex V4 Annex 18: GMP Guidelines for Active Pharmaceutical Ingredients	European Commission Regulations and Guidance
Eudralex V4 Annex 20: GMP Guidelines for Quality Risk Management	European Commission Regulations and Guidance
Eudralex V4 Ch 4: GMP Guidelines for Documentation	European Commission Regulations and Guidance
Eudralex V4 Ch 4: GMP Guidelines for Documentation (new draft)	European Commission Regulations and Guidance

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