Ques:  "We had a question from the previous webinar on IQ, OQ, PQ:

 

“Mr. Lincoln, what if a validated commercial software was originally validated using a software system that is no longer supported by the software company and/or the commercial software has been updated.  Does the validation have to be repeated?  For example, Microsoft Version 7 was used as part of the validation process for Lab Solutions, a system software used to support Shimadzu spectrophotometers.  This was completed in 2007.  In 2026 Microsoft no longer supports Version 7 and/or Shimadzu has updated the Lab Solutions software.  What needs to occur to avoid a 483 observation during an audit? ” 

 

ANS: These situations happen frequently. Usually as part of your annual QMS Review. you consider the status of existing V&V's, and that would apply here.  If nothing has changed in terms of the validation's issues being resolved by the validation, that the resolution / answers are still valid, then the version or updates involved in components of the V&V would not be an issue - that's basically the 'bottom line'. 

On the other hand, if the updates / obsolesce, et al, was due to any inherent defect in the supporting test mechanisms, then there is an issue, and a possible re-verification or re-validation may be required, and any additional follow-ups to remediate any product affected may need to be addressed, depending upon Failure Investigation / Root Cause Analysis findings. Ditto if there's any negative trends / irregularities in the data provided by the spectro system, per your NCMR / CAPA system. 

You should call out this analysis and results in your QMS management review documentation, whether done now or as part of any upcoming annual review, and revisit as necessary in the future, if necessary per the above.

- jel@jelincoln.com 02/10/2026