FDA recently issued a guidance document on “Computer Software Assurance for Production and Quality System Software”. This guidance offers clear, practical recommendations for validating software used in medical device production and quality systems. Designed to support compliance with 21 CFR Part 820, this guidance builds on the foundational “General Principles of Software Validation”. It emphasizes a risk-based approach to help manufacturers focus validation efforts where they’re most needed, enhancing product quality while avoiding unnecessary burden.
Rather than defaulting to exhaustive scripted testing, CSA encourages using a mix of tailored methods like unscripted testing, continuous monitoring, and leveraging supplier documentation to establish and maintain confidence in software performance. The guidance is grounded in FDA’s vision of helping manufacturers produce high-quality devices while adapting to the realities of modern automation, data processing, and agile development cycles.
By acknowledging the role of automation and advanced technologies in reducing risk and optimizing production, the FDA is encouraging smarter validation strategies that align with innovation. For companies navigating quality systems, this is an opportunity to rethink validation strategies and make room for smarter, faster solutions without compromising regulatory expectations or patient trust.
Read the full FDA guidance here.
