Quality Management 2.0 Blog

21 CFR Part 11 Software Validation As a Value Added Activity

Posted by Mary McAtee on Mar 27, 2014 @ 12:00 PM

Everyone that participates in the Life Sciences industry that uses software anywhere in their processes has wrestled with the challenges of Software Validation. Companies spend a considerable amount of time, money, energy and expertise in assuring that they address all of the requirements necessary as defined in in 21 CFR Part 11 to make sure that the software is going to both satisfy the FDA regulatory requirements and meet business expectations. The most challenging validation portion seems to uniformly be Process Qualification (PQ). The time and effort to determine and address where the software capability ends and the human process interaction begins can be very challenging. It is easy to miss some of the important supporting elements that are absolutely required and necessary to make Process Qualification successful. If we were to quantify those requirements at a very high level it would boil down to:

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Topics: IBS America, Mary McAtee, 21 CFR Part 11 FDA Validation Software, Process Qualification (PQ)

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