Regulatory Open Forum

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  • 1.  ERP systems

    Posted 03-Jul-2011 10:43
    I would recommend reading the GAMP software validation guideline (through ISPE) and reading the FDA guidance "General Principles of Software Validation" (2002) for compliant help with the software validation process, including writing clear, concise Requirements.  I have implemented many systems and use these documents as my roadmap.  

    Linda Coombs
    Sioux Falls SD
    United States