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