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  • 1.  Software Validation

    Posted 06-Feb-2012 15:11

    Hi Everyone,

    I have a questionin regards to this.... this seems like a gray area of validation.

    We currently use a couple of softwares and none are validated....
    I am trying to see if anyone on the forum uses them and if you validated them and what company did that?
    * SAP
    *Intelex

    I am a little curious to if the software developers validate their software them us as clients dont need to validate it also, but I am under the impression that Intelex isnt validated.

    Please guys, throw some light on this, as much will be appreciated!!
    -------------------------------------------
    Uche Jumbo
    Quality Assurance Specialist
    Corn Products International
    Bedford Park IL
    United States
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  • 2.  RE:Software Validation

    Posted 06-Feb-2012 15:45
    Applicable is 21CFR820.70(i): "When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. ..." 
    Even if the supplier of the software has done some level of validation, the phrase "...for its intended use..." means that there needs to be validation at the company using the software that can show it fulfills and will fulfill its intended purpose.

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    William White
    Senior Consultant
    Quality System Strategies LLC
    Elkhart IN
    United States
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    Original Message


  • 3.  RE:Software Validation

    Posted 07-Feb-2012 16:58

    Great! Thanks for reiterating that...
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    Uche Iloeje
    Quality Assurance Specialist
    Corn Products International
    Bedford Park IL
    United States
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    Original Message


  • 4.  RE:Software Validation

    Posted 07-Feb-2012 11:00
    Hi Uche,

    The software will need to be validated for FDA purposes.  We are currently validating an EPDM software that is similar to Intelex for one of our clients.  You should keep in mind that you will also need to validate the server before the software is loaded onto it. 

    Once you have the software configured to your organizational structure, you will need to validate the system against the specifications provided.  You will need to write test scripts and protocols and then execute them.  Following testing you will need to create a validation report.

    You will also need to have SOPs in place on how to use the software and a few other corresponding IT SOPs.

    Depending on the availability of your IT personnel, this work can take about 4-6 weeks to complete.

    If you like, RAA can provide an estimate for these services.    Please email (mtomasovich@regaffairs.net) and we can set a time to talk.

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    Michael Tomasovich
    Director Business Development
    Regulatory Affairs Associates
    Inkster MI
    United States
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    Original Message


  • 5.  RE:Software Validation

    Posted 07-Feb-2012 11:04
    FDA has guidelines called General Principles of Software Validation.  the response below is very much to the point - there is no such thing as buying validated software.  This would be equivalent to buying a CNC machine built in the 1970's for use making car brakes and saying it has been validated in the past so you can use it in 2012 on the moon making oxygen tanks!  Different environment, different uses (even if only slightly).

    Some simple guidance steps (call me for more details: nine 5-two, five five six 3-four-seven0)

    First: SAP will be hard to validate and should have been done during implementation. Get your hands on all the test scripts that the business teams no doubt used during CRP's and other dry runs.  Find out what data and records flow through that system that can be argued to be quality related - lot tracking, quality test results, etc.  Rank all of these uses as HIGH or CRITICAL, try to rank others as lower.  You can do "risk-based" testing on these.  Get approved documents that state the requirements for how these portions will handle data flows and exceptions.  Next use that test scripts you found and build in some more quality related scenarios like a recall situation.  Now run all of those tests through the system against KNOWN DATA.  You may want your IT group to setup a mirror QA environment just so your team can load that dummy data.  also try to get your IT group to define the process by which changes are being made (from Dev to Test to QA to Production) and then document this in a quality record or procedure.  Don't forget to do some audit trail testing as well - if the quality record only exists SAP, FDA will want to know how you can be sure it wasn't changed a la 21 CFR Part 11.  All of this will give you good evidence that you are doing your best to make sure the system handles quality records in a safe manner.

    All the best! 

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    Matt Mortensen
    Senior Quality and Regulatory Specialist
    Cardiocom
    Chanhassen MN
    United States
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    Original Message