Webinar Transcript - Part 11 – Electronic Records and Electronic Signatures

The transcript of the webinar “ Part 11 – Electronic Records and Electronic Signatures ” conducted by ComplianceOnline, provides an insider's view FDA's current thinking regarding the scope and application of Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11). Additionally, the transcript provides guidance in fulfilling requirements in the statute and parts of FDA's regulations for maintaining records or submitting designated information electronically.

You Will Learn About:

• Scope and Application of Part 11.
• FDA's Part 11 Approach
  • Validation
  • Audit Trail
  • Legacy Systems
  • Record Copies
  • Record Retention
  • Enforcement