Title: Document Controls for Medical Devices (Subpart D)
Course: PW-Course-Import-Test > Section: Module 3: Document Control

Module 3

In this section we will explore the importance of controlling documents that are part of the Quality System. We will review industry documents and the Preamble for examples and context related to the requirements of Document Control.

Documents that are part of a Medical Device Quality System provide guidance and direction to comply with applicable regulations. It is important to control the content that is provided so that changes/revisions reflect appropriate, intended, and compliant content.

Watch

Watch the narrated presentation Document Control for an exploration of the specific 21 CFR 820.40 requirements for Document Control.

Now explore these concepts in more detail with the following readings and videos.

Why are Document Control requirements important?

The “objective evidence” that is presented to regulators that are charged with 21 CFR 820 oversight (i.e., the material that is actually “investigated”) is controlled through Document Control. Failure to comply with basic document control requirements will result in 483 citations. A compliant medical device quality system is expressed through a library of documents that are developed to provide guidance to the regulations to all levels of employees at the firm. One of the fundamental pieces of a compliant quality system is a well defined and documented Document Control system.

The Document Control process controls the written guidance that is developed specifically to ensure compliance with the regulations. Various types of documents are controlled through this process.

Read

The article below, Document and Change Control in the Design Process, is an example of a high level overview of a medical device control system. As you read the article look for the different types of documents that are controlled through document control and the specific requirements related to Good Documentation Practices (GDP). Change Control and Document Control are tied closely together. Look for some of the differences between Document Control and “overarching” Change Control.

Read Document and Change Control in the Design Process.

Read the Preamble comments related to document control starting with Comment #93 for additional context on Document Control requirements.