Readiness becomes visible through records.
FDA CSASoftware inventory
Keep this as a named evidence object for FDA CSA: source basis, owner, status, review question, and update trigger should be visible before reuse.
Intended-use statement
Keep this as a named evidence object for FDA CSA: source basis, owner, status, review question, and update trigger should be visible before reuse.
Risk assessment
Keep this as a named evidence object for FDA CSA: source basis, owner, status, review question, and update trigger should be visible before reuse.
Assurance plan
Keep this as a named evidence object for FDA CSA: source basis, owner, status, review question, and update trigger should be visible before reuse.
Testing rationale
Keep this as a named evidence object for FDA CSA: source basis, owner, status, review question, and update trigger should be visible before reuse.
Objective evidence record
Keep this as a named evidence object for FDA CSA: source basis, owner, status, review question, and update trigger should be visible before reuse.
Deviation/issue log
Keep this as a named evidence object for FDA CSA: source basis, owner, status, review question, and update trigger should be visible before reuse.
Change impact assessment
Keep this as a named evidence object for FDA CSA: source basis, owner, status, review question, and update trigger should be visible before reuse.
Reviewer approval
Keep this as a named evidence object for FDA CSA: source basis, owner, status, review question, and update trigger should be visible before reuse.
Periodic review record
Keep this as a named evidence object for FDA CSA: source basis, owner, status, review question, and update trigger should be visible before reuse.
Each object needs review before reuse.
question bankSoftware inventory
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Intended-use statement
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Risk assessment
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Assurance plan
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Testing rationale
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Objective evidence record
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Deviation/issue log
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Change impact assessment
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
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.