Regulatory Open Forum

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  • 1.  Software Validation

    Posted 18-Sep-2019 13:05
    Hello - 

    I am new to software validations. Where should I start when learning about and considering validating software that is used under the QMS? My company will be moving to a new management system but I am unsure how to support from a regulatory perspective to get SAP validated.  

    Thank you, 

    Meghan Moore

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    Meghan Moore
    Regulatory Affairs Specialist
    Andover MN
    United States
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  • 2.  RE: Software Validation

    Posted 18-Sep-2019 13:08
    Hi, 

    Have you looked at this guidance? https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-principles-software-validation


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    Karen Zhou
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    Original Message


  • 3.  RE: Software Validation

    Posted 18-Sep-2019 13:34
    Refer to GAMP5 Methodology and it will help with the validation strategy and extent of Validation needed.

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    Loganathan Kumarasamy, MS RAC
    Senior Consultant
    Waukegan IL
    United States
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    Original Message


  • 4.  RE: Software Validation

    Posted 18-Sep-2019 14:17
    When I validate QMS software applications (off-the-shelf or designed in-house), I also now apply ISO/TR 80002-2 in addition to GAMP 5 and FDA's guidance document, as ISO/TR 80002-2 is recommended regarding ISO 13485:2016 clauses 4.1.6, 7.5.6 (fourth paragraph), and 7.6 (sixth paragraph).

    Hope this helps,

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    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com
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    Original Message


  • 5.  RE: Software Validation

    Posted 19-Sep-2019 05:52
    For electronic quality management systems, i.e. document control, corrective action, customer complaints, where all information is kept digital and interfaced on the computer, generally I use GAMP5 for computer system validation (CSV) https://ispe.org/publications/guidance-documents/gamp-5.  The FDA guidance as cited is helpful, but if you really want to know the ins and outs of software validation in supporting roles of quality management systems GxP processes GAMP5 is fairly comprehensive.  Keep in mind GAMP5 was generated for the pharmaceutical industry, so you will have to adjust as necessary if working in medical device area.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 6.  RE: Software Validation

    Posted 19-Sep-2019 11:17
    Hi Meghan,

    I'm just finishing up an SAP validation. Feel free to message me for moral support. :) I used the ISO 80002-2 for the most part. I actually think it is very helpful and well-written. As with most standards, it can't be really specific because it has to apply broadly but it does a good job with giving examples and options that best suit your situation. 

    Good Luck!

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    Maddi Myers
    Regulatory and Quality Project Manager
    Carver MN
    United States
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    Original Message


  • 7.  RE: Software Validation

    Posted 19-Sep-2019 14:31
    Please take a look at this webinar by Greenlight.guru and FDA, before you do a deep dive into all of the useful documents that others have provided and/or start budgeting hundreds (for SAP could be more) of hours of validation activities.
    https://www.greenlight.guru/webinar/fda-case-for-quality-4 

    Oh, and please take up Maddie on her offer for moral support :-).

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    Michael Zagorski RAC
    Director of Regulatory Affairs
    Pittsburgh PA
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    Original Message


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