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Regulations/FDA CSA/Actors & Services
Actors & Services · FDA CSA

Actors & Services for FDA CSA.

This page maps the people and service routes around the regulation. It shows who needs which evidence view and where iFeed can support review, translation, training, or readiness work without overclaiming.

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
/ Actors

Different owners need different evidence views.

FDA CSA
Actor 01

CSV/CSA lead

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for FDA CSA.

Actor 02

quality approver

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for FDA CSA.

Actor 03

system owner

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for FDA CSA.

Actor 04

process owner

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for FDA CSA.

Actor 05

IT owner

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for FDA CSA.

Actor 06

vendor manager

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for FDA CSA.

Actor 07

automation lead

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for FDA CSA.

/ Service fit

Where iFeed can help without overclaiming.

bridge work
Route 01

Source-to-evidence mapping

Convert source material into evidence objects, owners, gaps, and next actions.

Route 02

Checklist evaluation

Review completed readiness sheets and identify unclear or unsupported claims.

Route 03

Governance sprint

Create a practical two-week route for inventory, role mapping, evidence review, and update protocol.

Route 04

Training/workshop

Turn source reading into role-specific literacy and operational confidence.

/ 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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