Editor's note: This is the final post in a series of five summarizing a podcast series devoted to CSA. Links to previous posts are listed below.
If you spend an inordinate amount of time documenting your computer system validation (CSV) efforts, you're not alone. Because current CSV guidelines prioritize documentation, most life sciences manufacturers spend approximately 80% of their time documenting protocols and test results, primarily to appease auditors, and only 20% of their time testing the software. The thinking is that the more paper you generate, the better you validate. According to the FDA, this is not only wrong, but it could also be dangerous.
The Case for Quality (and Automation)
One of the main findings of the FDA's Case for Quality initiative was that the industry's heightened focus on meeting regulatory requirements versus adopting best quality practices could actually increase patients' risk. A document-centric, compliance-based approach impedes the use of risk-based critical thinking in the validation process. It also discourages investment in digital technologies that dramatically streamline validation efforts, leading to faster ROI and time to market.
With computer software assurance (CSA), the FDA hopes to "right-size" validation by emphasizing the use of critical thinking and automated systems. According to Francisco (Cisco) Vicenty, CDHR Program Manager at FDA, "Automated systems provide manufacturers advantages for reducing or eliminating errors, increasing business value, optimizing resources, and reducing patient risk. These capabilities provide significant benefits in enhancing product quality and safety."
Templates and Protocols
Traditional computer software validation can take several months for a single system. Excessive reviews and approvals of protocols and other documentation further extend this timeframe. Automating protocols not only reduces validation time (from months to days, in some cases) but also fosters a continuous improvement process that extends far beyond the initial deployment. That's because when you digitize, you are producing records, not just documents.
Take, for example, the installation qualification (IQ) protocol. The IQ isn't just for validation. You use it each time you re-install or upgrade the system. If you have not digitized your validation process, you must retrieve the IQ from a document archive or document management system, print it as a PDF, then walk through the test steps. If you have digitized your validation, the IQ protocol is readily accessible as a record in a relational database management system; you can quickly and easily perform the IQ again.
CSA raises exploratory or ad hoc testing as an option. With these testing methods, you can use a video screen recording as documented proof, and the proof is not a document at all; it's a video. If you've digitized your validation, you can include that video as objective evidence at a test-step level; the attached video proves the test step was successfully executed.
Best of all, when you digitize your requirements (user, functional and design) and your qualification protocols as records, you can relate one record to another and automatically generate a dynamic traceability matrix in minutes, not days.
Don't shy away from investing in technology that can help you realize high product quality and reduce your validation burden. The FDA recognizes traditional CSV as an obstacle to the implementation of automation and digital technologies in the life sciences. The Agency is working to rectify the problem with CSA.
The flipped paradigm emphasizes critical thinking (risk-based), assurance needs, testing activities, and documentation, in that order. While documentation remains part of the methodology, the real focus should be on generating records, not simply documents. And those records should be of value to the organization, not only used as backup for an audit or inspection.
Want to dive deeper into documentation and CSA? Click on the link below to listen to the full podcast.
Steve Thompson has worked in Life Sciences for over two decades in both Information Technology and Quality Assurance roles. He’s a certified systems auditor and has audited hundreds of companies globally. A published author, a frequent speaker at industry conferences, on the Board as a Director for PRCSQA, Editorial Advisory Board for ISPE, and Elite Faculty member for KENX, and Adjunct Lecturer, Temple University, School of Pharmacy, RA/QA Graduate Program. He was honored with an APEX 2020 award of excellence for a peer-reviewed article he co-authored for Pharmaceutical Engineering on Blockchain. Currently, as Director Industry Solutions at ValGenesis, Steve helps Life Science organizations realize the potential benefits of advanced technologies, along with inherent risks.