Regulatory Open Forum

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  • 1.  Software Validation Consutlant

    This message was posted by a user wishing to remain anonymous
    Posted 14-Dec-2022 09:45
    This message was posted by a user wishing to remain anonymous

    Hello, 

    We are a small medical device manufacturer looking for a software validation consultant, as we implement an eQMS and ERP/SCM systems. If you are or know of a great consultant, please reply.  Thank you.


  • 2.  RE: Software Validation Consutlant

    Posted 15-Dec-2022 10:08
    I would recommend CREO.  https://www.creoinc.net/  They have a team that specializes in the full spectrum of Quality Management of IT systems including CSV, supplier audits, program assessments, data integrity, Part 11, cyber security, etc. 

    Contact Kevin DeLeon at kdeleon@creoinc.net or 816-215-1243 (USA).

    Good luck!



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    Janet DeLeon
    CEO
    DeLeon Pharmaceutical Consulting, LLC
    janet@deleonpharma.com
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