Is Your Document Control System Out Of Control?

Document control is always an interesting topic for discussion.  It seems like a simple topic and area for compliance, but I often run into companies with document control systems that are overly complicated and difficult to manage.  Many companies separate document control for quality system procedures/processes from other types of change control.  In reality, document control is one element of the overall change control and records management requirements.  There are many procedures, formats, tools, and/or styles for managing quality documents and records.   Let’s take a look at how these key activities are related and why we should focus on implementation of strong change control processes within the quality systems — rather than just a document control process.

As you look at the various regulations and/or standards like 21 cfr (210, 211, 820, 600, etc.), ISO (9001, 13485, etc.), EU, JPAL, etc., they all require document and change control/management.  Additionally, 21 cfr 11 describes the FDA requirements for the use and management of electronic records.