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  • 1.  PV software validation process

    Posted 08-Aug-2013 21:04
    Does anybody have any experience on the installation of web based or cloud based PV software.  I not expecting to do any modifications or customizations and the software already has a prevalidated package for Part 11.  I would only need the validation in our IT enviroment, training, specific SOPS, product specific support documents and other doc to support the PV-Master File.    But on the IT part, how long should I expect it to become validated and in production. I would like to know experience from the big commercial packages and from the smaller existing packages that are popping up.


    Thanks

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    John McLane
    COO & VP Clinical and Regulatory
    Clinquest, Inc.
    Hudson MA
    United States
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  • 2.  RE:PV software validation process

    Posted 09-Aug-2013 03:01
    Dear John

    As I may have mentioned before in responses to this forum - it is impossible to purchase Part 11 compliant software. You can only purchase software that if installed and operated in compliance with the applicable regulations can become Part 11 compliant. Only the user can make the system Part 11 compliant.

    Even where you use a hosted system, you as the user remain responsible for the validation of the system, whether you had anything to do with or not. That has caused several companies quite some headache during inspections, when they were unable to present the validation evidence (their response: that was done by the vendor and they gave us a certificate was dismissed as wholly inadequate).

    Systems from vendors with a large customer base in the regulated industry usually are easier to validate. The effort is difficult to gauge without knowing your specific circumstance. You normally look at several months effort.
    PV software has been the target of inspections, from both the US FDA and European agencies. These systems are often owned by regulatory affairs departments, which don't happen to have much experience with regulatory inspections. That adds an extra level of complication.

    Hope that helps
    Siegfried

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    Siegfried Schmitt
    Principal Consultant
    PAREXEL
    Braintree, Essex
    United Kingdom
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    Original Message


  • 3.  RE:PV software validation process

    Posted 09-Aug-2013 09:09
    Thanks Dr. Schmitt

    I was aware that we would need to have our own validation and user testing.  I also want to get an idea of the interface people have had as they do this installation and working with these types of companies.   

    -------------------------------------------
    John McLane
    COO & VP Clinical and Regulatory
    Clinquest, Inc.
    Hudson MA
    United States
    -------------------------------------------






    Original Message


  • 4.  RE:PV software validation process

    Posted 10-Aug-2013 06:33
    Dear John. Following up on Siegfried's explanation, I would like to add the following points: Validation of a SW (and in this case validation to ensure compliance with 21 CFR Part 11) involves a set of activities that can be clearly identified and its steps prescribed. What vendors normally offer are document packages that allow performing and recording/archiving these activities. As Siegfried mentioned, you cannot be in compliance just by getting and installing the SW, as you have to perform the validation activities as well. Sometimes vendors also offers to do the validation for you, however you have to be able to ensure what is being performed is complete and covers all the Part 11 criteria. The review of the validation documentation can be done by someone from your SW-QA department (if you have one in-house) or by a consultant specializing in this area. In short, the vendors can only claim that their SW supports Part 11 compliance,; however the real proof is when you actually perform and record the validation steps. Best, Vahe ------------------------------------------- Vahe Ghahraman Director, Regulatory Operations Millennium/Takeda Cambridge MA United States -------------------------------------------
    Original Message