With the large number of medical device, pharmaceutical, and biotech companies beginning to leverage the power of the cloud, coupled with the upcoming release of the FDA’s Computer Software Assurance (CSA) guidance, there has never been a better time to dive into the calming waters the cloud offers.
The current Part 11 guidance and medical device cGMP quality system regulations were derivedsx before the inception of the cloud and lacked clear direction on computer system validation (CSV) and its necessary documentation. Further, these now dated regulations had many unintended consequences due to manufacturers misinterpreting the regulations that led to the over-validatation of computer systems and testing every aspect of their software, deeming it a necessary checkbox in their CSV and manufacturing processes.
This belief created a heavy documentation burden in the CSV process, which resulted in manufacturers rejecting the use of automated systems and new technologies, assuming it would further increase their validation burden and cost. Traditionally, regulated companies also struggled to understand the root cause of issues to improve product quality as their focus was on compliance and validation – not critical thinking about the system impact on patient safety, product quality, or quality system integrity.
This confusion around non-product computer system requirements has created a significant barrier for both the FDA and for life sciences companies to embrace new technologies like cloud, artificial intelligence, or automated testing, that can help drive innovation and deliver improved safety and quality. Non-product software is defined as any software that is not directly used in a medical device, medical device as a service, or end-product (i.e., QMS, ERP, LIMS, LMS, and eDMS applications as well as software tools). It includes all the software used in manufacturing, operations, and quality system activities, which would follow the 21 CFR Part 820.70(i) guidance. The goal of this white paper is to dispel the ingrained beliefs that on-premise systems are safer, and help regulated companies understand the inherent benefit and decreased burden of risk with today’s cloud systems.
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