Regulations, standards, and guidelines
COMPUTER SYSTEM VALIDATION
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff
- Guidance for Industry Computerized Systems Used in Clinical Investigations
- EudraLex Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Annex 11: Computerised Systems
- FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures
FDA GUIDANCE FOR INDUSTRY
- Guidance For Industry Good Laboratory Practice Questions and Answers
- ICH Q9: Quality Risk Management
GLP
- FDA 21 CFR Part 58 – Good Laboratory Practice For Nonclinical Laboratory Studies
- OECD ENV/MC/CHEM(98)17 Principles on Good Laboratory Practice
- World Health Organization Good Laboratory Practice Handbook
GMP
MEDICAL DEVICE