Sage X3 CFR Part 11 Compliance

Are there any pharma/biotech/medical device companies using Sage X3 in an Part 11 qualified environment?  I am looking to start a discussion on the validation processes required to qualify it in a GMP environment.

Thanks

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  • Hello Lisa,

    CFR 21/11 Validation can be tricky.  It is typically associated with company processes, however, security and audit might be something to consider.  An example might be "change reason codes" and "electronic signatures".  Your industry might require that specific entry screens provide an additional layer of security that monitors field level changes.  This is extreme, but, X3 might have a few tools that can assist with this effort.

    Perhaps further discussion would be helpful?  Let me know.

    Best,

    Tom

Reply
  • Hello Lisa,

    CFR 21/11 Validation can be tricky.  It is typically associated with company processes, however, security and audit might be something to consider.  An example might be "change reason codes" and "electronic signatures".  Your industry might require that specific entry screens provide an additional layer of security that monitors field level changes.  This is extreme, but, X3 might have a few tools that can assist with this effort.

    Perhaps further discussion would be helpful?  Let me know.

    Best,

    Tom

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