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)

Using your QMS to Empower Change Agents

Posted by Mary McAtee on Mar 24, 2014 @ 12:00 PM

“Give the people a light and they will see their way."  It was an unlikely source that brought this message home to me.

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Topics: Quality Management Systems, Quality Management Software, QMS, CAPA Software, CompliantPro, CAPA, Mary McAtee, Corrective Actions and Preventive Actions, Nonconforming Material Reports, NCMR

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

Quality Management Data - Historical Analysis

Posted by Mary McAtee on Mar 04, 2014 @ 11:00 AM

Tribal Knowledge: Quality Management Data for Historical Analysis                                     

Ever since people began handing down information from person to person and parent to child, there has been something called tribal knowledge. Almost everyone can point to a specific skill they have or knowledge they possess that was transferred to them by an elder. This elder may have been a relative, a community member, a teacher or a coworker. I certainly rely regularly on wisdom and skills I gained from all of the above. One situation in particular stands out in my memory as a teachable moment I have never forgotten.                                                                       

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Topics: Quality Management Systems, Quality Management Software, IBS America, Mary McAtee, Quality Data Management, Best Practices

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