The intention of the 21 CFR Part 11 ruling is to ensure an unquestionable record of every change made during a product lifecycle. To meet this requirement, product development projects need repeatable procedures to track changes and signoffs. For medical device companies, that means two things:

  • Meeting the FDA’s requirements for electronic signatures. They are not the same as digital signatures like those provided by Verisign, Entrust, or other commercial entities.
  • End-to-end traceability to prove full compliance.


Compliance is only ever accomplished when the right people do the right things.  This webinar will cover key points to meeting compliance, including:

  • Secure access.
  • Configurable workflow.
  • Electronic signatures.
  • Accurate change history.
  • Trace reports.


Learn the necessities to 21 CFR Part 11, and see where software applications can create efficiency and confidence in your process.

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