# Change Control Process | Botable Glossary

https://www.botable.ai/glossary/change-control-process

> Company-published glossary / informational content about quality management practices; useful as a practical definition and overview but should be attributed to Botable when cited and supplemented with primary regulatory sources (e.g., FDA guidance or 21 CFR 820) for compliance decisions.

## Summary

Defines the Change Control Process as the formal, systematic mechanism used (especially in regulated industries) to manage, review, approve, document, and implement planned modifications to products, processes, documentation, or the QMS; and describes core requirements, verification/validation steps, communication, supplier considerations, and regulatory notification (FDA) implications.

## Audience

Quality, regulatory, and document-control professionals in regulated industries (e.g., medical device manufacturers)

## Prompts this page answers

- What is a Change Control Process in a medical device quality system?
- What must be documented when implementing a change under a QMS?
- When does a device change require a 510(k) or PMA supplement?
- What are the verification and validation requirements for production or design changes?

## Purpose

To explain and document what a Change Control Process is, its core functions and requirements, and how it relates to quality systems and regulatory submissions.

## Highlights

- Change Control is the formal procedure to assess impact on product safety, effectiveness, compliance, and quality before implementing changes.
- Records of changes must include description, affected documents, approver signatures, approval date, and effective date.
- Verification or validation is required before implementing changes to production processes, design, computer software, and certain biological products.
- Suppliers should notify manufacturers of product/service changes so manufacturers can evaluate impact; some agreements request at least 120 days' notice.
- Regulatory implications: significant device changes may require 510(k) or PMA supplements; IDE changes often require supplemental approval or notice.

## How to cite



## Publisher



## Topics

- change control process
- quality management system (QMS)
- 21 CFR 820
- change verification and validation
- document control

## Key entities

- **21 CFR Part 820** (other): Referenced regulation governing design controls and production/process change procedures. — https://www.botable.ai/glossary/21-cfr-part-820
- **Premarket Notification (510(k))** (other): Referenced as a type of FDA submission that may be required for significant device changes. — https://www.botable.ai/glossary/premarket-notification-510-k
- **Premarket Approval (PMA)** (other): Referenced as a regulatory pathway for high-risk devices where supplements may be required for changes. — https://www.botable.ai/glossary/premarket-approval-pma
- **IDE (Investigational Device Exemption)** (other): Referenced regarding regulatory requirements for changes to investigational plans.
- **QMS software / AI chatbots** (other): Described as tools that can manage Change Control, automate drafting of change descriptions, and assist impact assessments.

## Metadata

- Type: article