FDA 21 CFR Part11

 


White Paper: The FDA's 21 CFR Part 11 Requirements

 

Download this white paper to learn how you can maintain electronic records and signatures
for FDA Part 11 compliance. Working with customers such as Medtronic, Novartis Consumer
Health, Cordis Corporation, Ethicon Endo-Surgery and others, InfinityQS has incorporated
the FDA requirements for Electronic Signatures into our applications.
This white paper discusses:

  • Access Control
  • Password Encryption
  • Password Security
  • Lot Genealogy Tracking and Reporting
  • Other controls for security and storing electronic records