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  • 1.  Software validation

    This message was posted by a user wishing to remain anonymous
    Posted 26-Dec-2018 14:51
    This message was posted by a user wishing to remain anonymous

    I am struggling to determine how often should software used to control analytical equipment (GC, HPLC) be revalidated.  If there are no changes to the hardware or software, do we still need to revalidate?  Thanks.


  • 2.  RE: Software validation

    Posted 27-Dec-2018 00:59
    Any changes will be captured via change control to determine the need for full or part validation. as a hood practice, Annual software review is performed taking into consideration all issue logs, changes to either determine continuous improvement, CAPA or revalidation based on the review outcome. Continuous improvement abd capa if executed; the execution is done adopting to QMS.

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    Rashida Najmi, Sr VP
    Quality, Regulatory and Pharmacovigilance
    Piramal Enterprises Ltd
    Bethlehem PA
    USA
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    Original Message


  • 3.  RE: Software validation

    Posted 27-Dec-2018 04:44
    I am not sure if you are in the medical device field or pharma area, but there are sources for both areas.  For medical devices, ISO 13485:2016 talks about validating software which should be a risk-based approach.  In the pharma area, a commonly used guidance is GAMP 5.  If there has been no change to the hardware or software, then using a risk-based approach with justification/rationale, a validation review could be performed.  There is probably too much information to write from the sources available, but in short you would not always need to perform a re-validation.  Methods, review, and validation criteria should be established for the equipment/software that you have.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Software validation

    Posted 27-Dec-2018 07:40
    If there are no changes, re-validation is not necessary.  Especially with GC/HPLC methods where system suitability is performed for each run.  Any "re-validation" performed would cast doubt on the reliability of the initial validation.

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    Peter Smith
    Principal
    Smith GMP Consulting
    Narragansett, Rhode Island
    USA
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    Original Message


  • 5.  RE: Software validation

    Posted 27-Dec-2018 17:18
    I have personally re-validated systems based on internal audits and FDA audits. Also,in addition to this, if there is a major change in software functionality upon version updates, there is a definite re-validation required.












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    Archana Turumalla
    Validation Specialist
    Gaithersburg MD
    United States
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    Original Message


  • 6.  RE: Software validation

    Posted 02-Jan-2019 09:06
    I would consider the idea of requalifying the equipment and software in simplest terms.  I would potentially run a review of your system suitability and other standard acceptance checks as an audit through the preceding 12 months.  If there are no real issues identified I would simply write up a memo to file that you reviewed the documentation provided by the system, no changes have been made to the system, all data appear adequate with little to no failure of expected standard runs, and conclude the system is still functioning as expected.​

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    Victor Mencarelli
    Director Regulatory Affairs
    United States
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    Original Message


  • 7.  RE: Software validation

    Posted 02-Jan-2019 11:24

    There is no reason to re-validate software provided the software or associated hardware hasn't changed. Many people apply a calendar based approach similar to equipment maintenance or IM&TE calibration. However, this is not necessary, because the software, unlike equipment,  doesn't change over time. As a result, re-validation on a calendar basis should find nothing new and, therefore, doesn't add value.

    Similar reasoning applies to process validation. As long as the process produces conforming product, periodic re-validation is unwarranted. 

    For devices, the Medical Device Quality Systems Manual from December 1996 says, "As long as the process operates in a state of control and no changes have been made to the process or output product, the process does not have to be revalidated. Whether the process is operating in a state of control is determined by analyzing day-to-day process control data and any finished device testing data for conformance with specifications and for variability." The same reasoning applies to software re-validation.



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    Dan O'Leary
    Swanzey NH
    United States
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    Original Message


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