Articles & Clauses · FDA CSA · iFeed Regulations

/ Source units

The chapter holds the source skeleton.

articles · clauses · principles

This page does not flatten FDA CSA into a generic checklist. It identifies the specific source units that future interpretation, evidence objects, and public artifacts must trace back to.

Source unit 01

FDA CSA final guidance

Primary source for risk-based assurance of production and quality management system software.

Source unit 02

QMSR terminology revision

February 2026 revisions aligned CSA language with QMSR terminology.

Source unit 03

Production software scope

Manufacturing, inspection, automation, and production controls can be in scope.

Source unit 04

Quality management system software scope

eQMS, CAPA, complaint, supplier, document, and record systems may need CSA reasoning.

Source unit 05

Objective evidence

Records should show what assurance activity happened and why it was adequate.

Source unit 06

Unscripted testing

Can be appropriate when justified by intended use and risk.

/ Public boundary

Protected material stays protected.

citation not copying

Boundary

Use source-owner titles, status, and public summaries; do not reproduce protected standards or paid guide content.

cite · summarise · trace · do not copy

/ 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.

open

Official FDA PDF