People who know me are very aware of how much I love boats and getting out on the water. My father was a Merchant Seaman and my spouse and close friends tend to all have seawater in their veins. This love of the water includes a deep respect for the power and unpredictable nature of the ocean. Most misadventures at sea seem to be a case study in the precise definition of a “Cluster F&$@”. Every major and even minor disaster at sea seems to always involve several of the fates conspiring together to allow the progress of a bad situation to become worse. Let’s take just one recent example from the news. Rob Konrad, a former player for the Miami Dolphins, was several miles offshore on his 36 foot fishing boat. He fell overboard and ended up swimming over 9 miles through shark infested waters to reach shore in Palm Beach. Several contributing factors put him in that water swimming for his life. Almost any other person would have become another sad obituary but his physical conditioning overcame some really bad decisions on his part:Read More
Quality Management 2.0 Blog
Mitigation and Contingency Controls
My colleagues and I have addressed various approaches to formal Risk Assessment. We have talked about the methodology for utilizing Risk Assessment tools for overlooked areas such as Supply Chain Management. We even conducted a webinar on best practice for assessing and managing risk.
Risk Management as a Career Tool
In the last blog I vented my most annoying compliance issue. This week I thought I would switch gears to my most amusing and embarrassing Quality moments.
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:
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