Title: Module 3 Overview: Document Control
Course: PW-Course-Import-Test > Section: Module 3: Document Control

Module 3

In this module we will explore the importance of Document Control with respect to QSR compliance. The Quality System is comprised of a library of documents that describe all aspects of the Quality System and all approved Medical Device products. It consists of different types of documents that describe requirements, provide guidance, and record objective evidence to demonstrate compliance. The requirements for the control of documents are critical in order to maintain a state of compliance. We will explore the importance of Document Controls, the frequency in which non-compliances related to this section of the regulation occur across the industry, and the consequences of non-compliance.

Watch

Watch this short video to learn more about how and why Document Control is such a critical element of a quality management system.Introduction to Document Control Video Preview

The purpose of this module is to make you aware of the specific 21 CFR 820 requirements for Document Control. This section of the regulation is relevant to anyone who desires to be employed by any manufacturer of medical devices marketed in the United States. Within the medical device industry, and because of the significant compliance risk posed by inadequate Document Controls, it is common for firms to have specific training and career paths established for Document Control personnel.

Competency

After completing this module, you will be able to identify key components of good document control requirements within the medical device industry.

Learning Objectives

- Describe the purpose of document control.
- Identify the “core” elements of Document Control.
- Identify the basic rules for correcting and revising quality records as part of Good Documentation Practice
- Categorize the compliant vs non-compliant document control elements related to 21 CFR 11

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