FDA's CSA guidance, finalized in September 2025 and updated in 2026 to align with the Quality Management System Regulation, moves away from exhaustive scripted testing of every function. It encourages assurance activities matched to risk, which can include unscripted testing and making use of a supplier's own evidence. Formally, it applies to software used in medical device production and quality systems.
Why it matters for labeling
It reflects a direction that validation practice, including in pharma, has been moving in: more rigor where a failure could matter, less where it can't. A tool that verifies labels before release supports a release decision, which is the kind of function that warrants rigorous assurance, and a deterministic tool whose results are reproducible is easier to assure.
Common mistakes
- Reading CSA as permission to skip validation
- Applying it as a pharma requirement when it formally covers device software
- Accepting supplier evidence without checking it covers your intended use
- Not documenting the risk assessment that justifies the approach