Introduction to 21 CFR Part 11


Lesson Code: GVC-1202. This e-Lesson is aimed at personnel who require an overview of the 21 CFR Part 11 regulation and its associated terminology, how it affects regulated industries, and the criteria for complying with its requirements.


  • Category: Computer Use and Validation

Description

After taking this e-Lesson, you will be able to:

  • Explain the purpose of the 21 CFR Part 11 regulation
  • Define electronic records and electronic signatures
  • Explain what is meant by a hybrid system
  • Compare 'Open' and 'Closed' systems
  • List the Part 11 compliance requirements for Closed and Open Systems
  • Define audit trail and time stamp
  • Explain the purpose of operational, authority and device checks
  • Distinguish between biometric and non-biometric signatures and list their Part 11 requirements
  • Explain 'linking' of electronic signatures and records
  • Summarize the general action points required for achieving Part 11 compliance


KEYWORDS: Audit Trail, Closed System, Data Integrity, Electronic Records, Electronic Signatures, Open System, Time Stamp, Warning Letters, 21 CFR Part 11