21 CFR Part 11 and QMS Software Risk-Based Implementation 2025

Overview

Software / firmware design, development, testing / verification and validation, implementation and usage, is difficult to structure, manage, document and control, especially in the QMS with Pt. 11. For many companies the subject can be intimidating. Software and firmware use in regulated industry is under increased scrutiny by the U.S. FDA, and is a growing concern by all regulatory agencies worldwide. Quality Management System are heavily software / firmware driven in today's manufacturing, with the added concerns of 21 CFR Pt. 11 (Annex 11 in the EU), data integrity and cybersecurity. A comprehensive, corporate wide plan, accompanied by proper implementation and use of a defined life-cycl...e, and documentation, is a necessity. Growing "cloud" issues add urgency to upgrade control. Regulatory requirements also demand a product risk-based approach. And there’s IEC 62304 and GAMP(reg.) 5. What are the best practices? How can tougher regulatory (FDA and EU) expectations be met? What implementation and control is necessary to minimize software failures or breaches? How to use the FDA's own "model" to document SW V&V. This systematic approach also adds predictability (time and budget) to software development, implementation, use, and decommissioning. The US FDA requires that all device, production / test / lab equipment, and processes, especially the QMS, using software / firmware be implemented, used and validated according to strict requirements. Similar for the EU. This presentation focuses on the planning and execution of system-level software documentation, implementation use, and verification / validation, after basic developmental testing and de-bug. With the focus on QMS and Part 11 requirements, including data integrity and cybersecurity. It includes COTS (commercial off-the-shelf) and the growing field of "cloud"-based software. A suggested FDA model (mandated for submissions), that has been field-tested for over 20 years, is also defined, evaluated, implemented, with V&V documentation and test case examples. The focus is on the most recent issues the FDA has had in this area, and remediation approaches. Software issues considered are primarily QMS and 21 CFR Pt. 11. What are the data integrity and cybersecurity issues. How to determine risk-based. Related IEC 62304 and GAMP(reg.) 5 concerns. Read more