• (919) 844 2494
  • Warning Letter: Failure to maintain procedures, documentation (s6881c)

    Tags:

    Ofni Systems

    Failure to establish and maintain adequate procedures for the identification, documentation, validation or where appropriate verification, review and approval of design changes before their implementation, as required by 21 CFR 820.30(i).

    View the original warning letter.


    Recommended Solutions

    Compliance Training >>

    Recommended Solutions

    ExcelSafe >>

    Recommended Solutions

    Ofni Clinical >>

    Recommended Solutions

    Part 11 Toolkit >>

    Recommended Solutions

    Part 11 Advisor >>

    Recommended Solutions

    MedWatch Reporter >>

    Recommended Solutions

    Computer Validation >>

    Recommended Solutions

    Custom Programming >>

    Recommended Solutions

    Validating MS Excel Spreadsheets >>

    Recommended Solutions

    Access Databases >>