The following are a few helpful resources for understanding and complying with FDA rules and regulations:
• The FDA’s website
FDA U.S. Food and Drug Administration main site
• 21 CFR Part 11
Regulations surrounding Electronic Records and Signatures
• 21 CFR Part 58
Good Laboratory Practices for Nonclinical Laboratory Studies
• 21 CFR Parts 210 and 211
Current Good Manufacturing Practices for Manufacturing, Processing, Packing, or Holding of Drugs, and for Finished Pharmaceuticals
• 21 CFR Part 820
Quality System Regulations
• General Principles of Software Validation
Final Guidance for Industry and FDA Staff
• Computerized Systems Used in Clinical Investigations
Guidance for Industry for Computerized Systems used in Clinical Investigations
• ICH Q7A
International Conference on Harmonization Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients