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

• FDA 21 CFR Part 211 Current Good Manufacturing Practice For Finished Pharmaceuticals

MEDICAL DEVICE

• FDA 21 CFR Part 820 Quality System Regulation
• FDA Medical Device Quality System Regulation and Preamble