Document controls are the system of policies established by a company to control the creation, distribution, modification, and obsolescence of documents. The FDA has set regulations for document controls in 21 CFR 820 Subpart D. A company without adequate document controls risks the safety and effectiveness of medical devices, exposing consumers to unnecessary risk.

Document controls encompass both new documents and modifications to existing documents. Every document required by the quality management system established in the quality manual needs to be controlled.

Document controls should:

- ensure the accuracy of any document created for use in the company,
- distribute documents to the personnel that need them,
- control permissions such as viewing, downloading, printing, or editing,
- prevent outdated versions of documents from being used,
- prevent obsolete documents from being used, and
- ensure all documentation is adequate for its purpose.

Learning Objectives:

- 1.3 - Explain how a quality management system helps a company meet the guidelines from regulatory bodies.