Quality Management 2.0 Blog

Life Science Software Validation As a Value Added Activity

Posted by Mary McAtee on Mar 14, 2014 @ 11:00 AM

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 ensuring 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, Process Management Software, Mary McAtee, FDA Validation, Risk Management Software, Risk Assessment Software, FDA Validation Software, Life Science Software Validation, 21 CFR Part 11 FDA Validation Software

Join IBS America at The Medical Device Summit

Posted by IBS America on Jan 09, 2014 @ 10:08 AM

Join IBS America, Inc. And 200+ Medical Device industry professionals for panels, presentations, workshops and tons of networking opportunities with the industry's best!


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Topics: Quality Management Systems, Quality Management Software, IBS America, Quality, medical device compliance and quality software, medical device summit 2014, FDA Validation

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