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Regulations/FDA CSA/Evidence Readiness
Evidence Readiness · FDA CSA

Evidence Readiness for FDA CSA.

This page converts regulatory reading into evidence-readiness. It defines the records, owners, review questions, and trace fields that make a future checklist or readiness review defensible.

Source basis: Computer Software Assurance for Production and Quality System SoftwareUse: evidence-readinessBoundary: not legal advice
FDA CSA TRACE FDA CSA FINAL GUIDQMSR TERMINOLOGYPRODUCTION SOFTWQUALITY MANAGEME
Evidence objects

Readiness becomes visible through records.

FDA CSA
Evidence 01

Software 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.

Evidence 02

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.

Evidence 03

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.

Evidence 04

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.

Evidence 05

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.

Evidence 06

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.

Evidence 07

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.

Evidence 08

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.

Evidence 09

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.

Evidence 10

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.

Readiness questions

Each object needs review before reuse.

question bank
Question 01

Software inventory

Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?

Question 02

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?

Question 03

Risk assessment

Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?

Question 04

Assurance plan

Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?

Question 05

Testing rationale

Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?

Question 06

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?

Question 07

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?

Question 08

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?

Source anchors

Current public sources for FDA CSA.

official first

These links are the public source anchors for this workspace. Interpretation, checklists, and future assets should point back here before being reused outside iFeed.

Official FDA guidance

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.

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Official FDA PDF

FDA CSA guidance PDF

2026-02 · Guidance history notes February 2026 revisions to align terminology with QMSR amendments to Part 820.

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