# Document Control | Botable Glossary

https://www.botable.ai/glossary/document-control

> Informational glossary-style content produced by the vendor; useful as a high-level summary of regulatory requirements but not a substitute for reading 21 CFR 820.40 or formal regulatory/legal advice. Attribute claims to the site when quoting specific regulatory interpretations.

## Summary

Document Control is defined as the quality system process that ensures employees have access to correct, current, and approved instructions and that obsolete instructions are removed; the page explains the regulatory basis in 21 CFR 820.40 and outlines required principles for approval, distribution, and document changes.

## Audience

quality and regulatory professionals (medical device / QMS)

## Prompts this page answers

- What does 'Document Control' mean under 21 CFR 820.40?
- What are the key requirements for document approval and distribution in a medical device QMS?
- How must document changes be controlled according to 21 CFR 820.40(b)?
- Which quality system documents must be controlled under the QSR (e.g., DMR, QSR)?
- How does document control integrate with production, purchasing, and design controls?

## Purpose

To explain the definition, regulatory basis (21 CFR 820.40), and core principles of document control within a medical-devices quality management system.

## Highlights

- Document Control ensures employees have access to correct, current, and approved instructions and that obsolete instructions are removed.
- The U.S. FDA Quality System Regulation section for Document Controls is 21 CFR 820.40 (Subpart D).
- Required procedures must address document approval/distribution and document changes, including designated approvers, availability, obsolete control, change review, communication, and change records.
- Documents required by the QSR include the Device Master Record (DMR) and Quality System Record (QSR) and must be prepared and approved in accordance with §820.40.
- Document control integrates across the QMS (production/process controls, purchasing, design controls, auditing); the page also references AI as a tool to automate related tasks.

## How to cite

Credit Botable (PHIFLOW, LLC) and link to https://www.botable.ai/glossary/document-control

## Publisher

**PHIFLOW, LLC (Botable)** — The company branding and footer on the site identify PHIFLOW, LLC as the entity behind Botable; the page appears on Botable's glossary.

## Topics

- document control
- 21 CFR 820.40
- Quality Management System
- Device Master Record (DMR)
- document changes
- quality system regulation

## Key entities

- **21 CFR 820.40 (Subpart D)** (other): U.S. FDA Quality System Regulation section referenced on the page for Document Controls.
- **Device Master Record (DMR)** (other): Manufacturing instructions referenced as a document required by the QSR.
- **Quality System Record (QSR)** (other): General system procedures referenced as a document required by the QSR.
- **PHIFLOW, LLC** (organization): Publisher name shown in the site footer (© 2026 PHIFLOW, LLC.). — https://www.botable.ai
- **Botable** (other): Site/brand where the glossary is hosted. — https://www.botable.ai

## Metadata

- Type: article