Simply performing computer system validation or managing computer systems under CGMP conditions is not enough to ensure data integrity and data quality for data sets where AI/ML is intended to be applied.
Senior quality leaders and the FDA agree quality organizations supporting pharma manufacturing often fall short of providing the support necessary to maintain and increase regulatory compliance and product quality. At the same time, some do not understand their actions and believe they are obstructionist and reflective of a strict compliance mentality with little regard for the business and its success.
The pivot from 25 years as a medical device practitioner to the chief editor’s chair at Med Device Online has been fun, but not devoid of challenges. My initial fear – that stepping out of the hands-on device development and manufacturing trenches would inhibit my ability to make a tangible difference for device users – has given way to satisfaction in the knowledge that my experience can help to inform and guide others in the industry.
In a recent guest column on Med Device Online, FDA inspectional observations were summarized for the most recent fiscal year indicating 400 of the 1,030 inspectional observations written by CDRH investigators pertained to procedures for corrective and preventive action (CAPA) not being adequately established (and followed). At 39 percent of all device-related 483s in FY 2017, CAPA was the most prevalent observation.
Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), recently issued a statement in response to President Trump’s State of the Union Address, "While the passage of an additional two-year suspension of the medical device tax is a recognition of how important it is to bolster America’s leadership position in this industry, Congress must permanently repeal this disastrous policy in order to fully realize the long-term investments in patient care and job creation that are critical to growth.” Did he really say – disastrous? Oh yes he did!
At most medical device companies, mere utterance of the word recall is akin to mentioning the Dark Lord’s name in the Harry Potter series of novels: it’s simply not done, unless one wishes to invite misfortune upon oneself. In Harry Potter’s world, the Dark Lord (Voldemort) is referred to as “He-Who-Must-Not-Be-Named,” a moniker easily coopted by “recall”-averse medical device companies into “That-Which-Must-Not-Be-Said.”
As a child and student, I was mostly an academic. I got report cards with lots of “A’s” on them, but they didn’t hand out trophies for that. I did earn two small trophies for being on the first place team in kickball tournaments (it would have been way cooler if that was dodgeball instead). I did win a “Louie” as the guitar-player in the high school jazz band. I still have the little trophy for my Louis Armstrong Jazz Award and every time I lay eyes upon it – I think to myself, what a wonderful world!
The Council of the European Union has adopted the European Medical Device Regulations (MDR 2017/745), which were published in the Official Journal of the European Union and entered into force on May 26, 2017. Are you ready?
The FDA requires medical device manufacturers to have clearly documented procedures for corrective action and preventive action (CAPA). Unfortunately, many medical device companies fail to prepare a good approach to their CAPA process, which is so important to the health and success of your company.
Let’s face it: manufacturing in a regulated environment is more expensive than commercial manufacturing. With all due respect to the venerable prowess of medical device manufacturing professionals, even a lean, mean, 5S, Six Sigma, 8D machine cannot offset the cost created by a plethora of requirements, guidance documents, and standards.
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