Facts and interpretation stay separate.
auditable readingSource fact
FDA frames CSA as risk-based assurance for production and QMS software.
iFeed reading
The shift is from scripted evidence volume to intended-use confidence and objective evidence.
Operational meaning
Validation worksheets should ask why this assurance method is right for this software and risk.
Do not overclaim
CSA is not less validation and not undocumented testing.
The useful question is what work this creates.
iFeed meaningIntended use
Assurance starts with what the software is used for in the quality or production process.
Risk-based assurance
Higher-risk use needs stronger evidence; lower-risk use can avoid unnecessary burden.
Assurance activity selection
Testing approach should match risk and use, not follow a fixed ritual.
Objective evidence
Records should show what was checked, by whom, with what result.
Unscripted testing
Exploratory and ad hoc testing may be appropriate when justified and documented.
Automation support
Tools can support assurance but need their own fit-for-use rationale.
Current public sources for FDA CSA.
official firstThese links are the public source anchors for this workspace. Interpretation, checklists, and future assets should point back here before being reused outside iFeed.
FDA CSA guidance
2026-02 · Current final guidance on computer software assurance for production and quality management system software; it supersedes the September 2025 final guidance.
FDA CSA guidance PDF
2026-02 · Guidance history notes February 2026 revisions to align terminology with QMSR amendments to Part 820.