Resources Library

Resources Library
Access our comprehensive validation resources and guidance documents to support your CSV/CSA initiatives, ensuring compliance and efficiency in your operations.
21 CFR Part 11 – Electronic Records & Electronic Signatures (FDA)
EU GMP Annex 11 – Computerised Systems (EMA)
General Principles of Software Validation (FDA, 2002)
21 CFR Part 820 – Quality System Regulation (Medical Devices)
ISPE GAMP 5 (Second Edition) – Risk-Based Approach
ICH Q9 – Quality Risk Management & ICH Q10 – Pharmaceutical Quality System
PIC/S PI 011 – Good Practices for Computerised Systems in Regulated ‘GxP’ Environments
GEON Annex 1 – Validation of Excel Spreadsheets (OMCL Network)
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