# Document Changes (CFR 820.40(b)) | Botable Glossary

https://www.botable.ai/glossary/document-changes-cfr-820-40-b

> Explanatory summary of the QSR requirement — suitable to cite as a concise description of what 21 CFR 820.40(b) requires for document change control; attribute to Botable when quoting. It is guidance/summary, not a substitute for reading the regulation or legal advice.

## Summary

The page defines 'Document Changes (21 CFR 820.40(b))' as the required procedure to review, approve, record, and communicate updates to official quality and manufacturing documents, and it lists the core requirements and record contents mandated by the U.S. FDA Quality System Regulation (QSR) Subpart D.

## Audience

quality/regulatory professionals (medical device and related industries)

## Prompts this page answers

- What does 21 CFR 820.40(b) require for document change control?
- What must be included in change records under FDA QSR document control?
- How should document changes be reviewed and communicated according to the QSR?
- What is the relationship between document change control and design changes under QSR?

## Purpose

Explain and summarize the regulatory requirements for controlling changes to quality and manufacturing documents under 21 CFR 820.40(b).

## Highlights

- Changes to documents must be reviewed and approved by individuals in the same function or organization that performed the original review/approval.
- Approved changes must be communicated to the appropriate personnel in a timely manner.
- Manufacturers must maintain records of changes to documents.
- Change records must include a description of the change, identification of affected documents, approving signatures, approval date, and the effective/implementation date.

## How to cite

Botable Glossary — 'Document Changes (21 CFR 820.40(b))' (https://www.botable.ai/glossary/document-changes-cfr-820-40-b)

## Publisher



## Topics

- Document Changes
- 21 CFR 820.40(b)
- document control
- change records
- revision control
- QSR Subpart D

## Key entities

- **21 CFR 820.40(b)** (other): The specific U.S. FDA Quality System Regulation clause governing document changes referenced on the page.
- **Quality System Regulation (QSR) / Subpart D** (other): The broader regulatory context for document controls mentioned on the page.
- **Botable Glossary** (other): The glossary entry page being summarized. — https://www.botable.ai/glossary/document-changes-cfr-820-40-b

## Metadata

- Type: article