The US FDA regulations for how life sciences companies process electronic files and signatures is known as 21 CFR Part 11. This regulation is changing as a result of the FDA’s Center for Devices and Radiological Health (CDRH) 2011 Case for Quality initiative, which found that the current regulations are causing companies to spend far more time on documentation than on testing and improving quality.
The CDRH along with the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research is drafting a document featuring new guidance on this subject: Computer Software Assurance for Manufacturing and Quality System Software. This document presents opportunities for streamlining the documentation process by changing the focus of CSV to critical thinking, risk management, patient and product safety, data integrity and quality assurance. Though this guidance is being developed for the medical device industry, the FDA has indicated that it will also apply to R&D, clinical and other groups within the life sciences industry that are currently following 21 CFR Part 11 regulations. This document should be considered when deploying the following kinds of systems:
- Quality management systems (QMS)
- Enterprise resource planning (ERP)
- Laboratory information management systems (LIMS)
- Learning management systems (LMS)
- Electronic document management systems (eDMS)
While we are awaiting the release of this new guidance, we are aligning with the computer software assurance process of applying critical thinking along with a risk-based approach to assure quality and data integrity. In addition, the application of automated/unscripted testing is enabling us to improve the quality of our work to ensure patient and product safety for our clients. We are tailoring our services to meet these new guidelines accordingly and are eagerly anticipating the FDA’s new guidance document “Computer Software Assurance for Manufacturing, Operations and Quality System Software” that is scheduled for release in 2022.
