FDA just released: Computer Software Assurance for Production and Quality System Software
- Document issued on September 24, 2025.
- The draft of this document was issued on September 13, 2022.
FOREWORD
- The FDA’s new guidance on Computer Software Assurance (CSA) is a game-changer for regulated industries.
- It marks a shift from the traditional CSV approach to a more risk-based, value-driven methodology.
What’s new in CSA?
The guidance introduces a paradigm shift:
- focus on intended use, risk to patient safety, and product quality—not exhaustive documentation.
- It encourages critical thinking and leverages modern testing practices to streamline validation.
Key applications:
- Manufacturing Execution Systems (MES)
- Laboratory Information Management Systems (LIMS)
- Quality Management Systems (QMS)
- Cloud-based platforms and SaaS tools
- Automation and robotics in production
- Data integrity controls and audit trail reviews
CSA vs CSV – What’s the advantage?
- Risk-based decision making over blanket testing
- Less documentation, more meaningful evidence
- Exploratory and unscripted testing encouraged
- Faster deployment of updates and innovation
- Alignment with Agile, DevOps, and modern SDLCs
This means more time for innovation, less time buried in paperwork, and better assurance where it counts.
CSA empowers teams to focus on value-added activities, reduce validation fatigue, and accelerate digital transformation across life sciences.
CSA empowers teams to focus on quality, not just compliance.
This is not just a guidance—it’s a mindset shift.
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Resource Person: BARBARA PIROLA