Guidance
The primary purpose of document control is to ensure necessary, accurate and up-to-date
documents are available to those personnel required to use them, to include, in the case of
outsourced operational functions, employees of external service providers.
Examples of documents that are controlled include, but are not limited to, operations manuals,
checklists, quality manuals, training manuals, process standards, policy manuals, and standard
operating procedures.
An electronic system of document management and control is an acceptable means of
conformance. Within such a system, document files are typically created, maintained, identified,
revised, distributed, accessed, presented, retained and/or deleted using computer systems (e.g. a
web-based system). Some systems specify immediate obsolescence for any information or data
that is downloaded or otherwise extracted (e.g. printed on paper) from the electronic files.