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

Module 3

In this module we learned about the importance of Document Control with respect to the overall compliance of the Quality System. We explored different types of documents that require control and the importance of GDP. We looked at the frequency of inspectional observations related to document control compliance and reviewed a Warning Letter with real life examples. We reviewed 21 CFR Part 11 for electronic document systems and compared it with the requirements of 21 CFR 820.40 Subpart D.

Study these Take-Away Notes for a review of the main points of this module. You can think of it as a study guide for your assessments.

Coming Up...

In the next module we will cover 21 CFR 820.70 - Subpart G - Production and Process Controls. Production and Process Controls are necessary to establish control of production processes related to manufacturing medical devices. After devices are “transferred” (Design Controls) to manufacturing, controls are necessary to maintain, preserve and produce the intended design. Production and Process controls exist to provide the framework of how the intended design state will be controlled and maintained. We will explore the importance of Production and Process Controls and the consequences of non-compliance.