Is NAV 2016 21 CFR Part 11 compliant?

Hi,

 

Does anyone know if NAV is 21 CFR Part 11 compliant?

Our customer will need it for lot traceability, TCF’s, RMA’s, etc..

Thank you in advance!

 

Carol

  • 21 CFR Part 11 compliant software is a misnomer. There is no such thing. The FDA regulation applies to defining the overall processes and procedures that must be in place. It is not simply about software.

    Reminds me of the ISO 9000 cert and software vendors pushing their software as "ISO certified". Another misnomer.
  • In reply to babrown:

    Oh yes, remember when "everybody" had to become ISO 9000 certed. We kept running around documenting everything for years, and after the project most was either forgotten or abandoned.
    And yes, like in most true ERP projects, then its really more about defining processes. Software is a minor thing.
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