FDA’s new CSA guidance: transforming software validation for production and quality systems

In late September, the FDA finalized its guidance on Computer Software Assurance (CSA) for software used in medical device production and quality systems. Replacing Section 6 of the earlier “General Principles of Software Validation,” CSA modernizes validation practices by shifting from the traditional Computer System Validation (CSV) model to a flexible, risk-based approach. The focus moves from exhaustive documentation to maintaining ongoing confidence in software performance, emphasizing assurance over validation.

The guidance aligns well with international standards, supporting compliance with ISO 13485:2016 in areas like software validation, risk management, and continual improvement. CSA also complements EU MDR requirements, including Annex I's General Safety and Performance Requirements and Article 10’s quality system obligations, making it suitable for global regulatory strategies.

Traditionally, CSV emphasized exhaustive documentation and uniform testing, regardless of risk. CSA shifts this by focusing assurance activities on software functions that could directly impact product quality, patient safety, or process integrity. It emphasizes intended use and process impact, with context-driven rigor applied to critical functions. This ensures alignment with real-world risk and operational relevance. The guidance promotes critical thinking over checkbox compliance, encouraging thoughtful risk assessment and appropriate rigor.

Another major change is the adoption of a binary risk classification: software features are categorized as either “high process risk” or “not high process risk.” This simplification helps organizations to prioritize the validation activities better. CSA also supports the use of vendor documentation and software development lifecycle (SDLC) artifacts as valid evidence of software reliability, rather than duplicating vendor testing.

While CSA streamlines assurance activities, it requires a shift in mindset for quality and regulatory professionals accustomed to extensive validation. QA/RA teams must recalibrate their approach, prioritizing risk-based decision making and context-driven documentation. Limited documentation could be acceptable, provided it is supported by a robust, well-documented risk analysis.

In summary, CSA introduces a smarter, more agile framework for software assurance in production and quality systems. It helps manufacturers reduce unnecessary effort, enhance efficiency, and uphold standards, while encouraging a risk-based mindset aligned with real-world impact.

At Aurevia, we can help you implement CSA effectively, guiding your team through risk-based validation, leveraging vendor documentation, and aligning your processes with both FDA expectations and international regulations.