Title: Records, Documents, and Change Controls
Course: BTEC-1300-301-302-303-F21 > Section: Quality System Regulations and the Quality Management System

The FDA relies on a company’s records and other documents. The FDA uses records and documents, or lack of record, to prove compliance or noncompliance. As a technician, you will generate these records as you manufacture items.

Document controls is a system that ensures that everyone in the company is using only the most current document.

Change controls refers to the process for making changes to documents. All changes to documents that are part of the quality management system must be evaluated and tested for safety and efficacy prior to implementation. This allows a company to be certain the quality of a final product won’t be compromised by a particular change.

Out of the seven subsystems, this is the one that biotechnicians like you will directly interact with.

Learning Objectives:

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