Learn from industry practitioners and experts why QA Document Control is a prerequisite to Quality Assurance. Quality assurance document control is the process used in the management, coordination, control, delivery, or support of an item required for quality assurance purposes. QA document control is an essential part of the quality assurance system for all aspects of GMP, GCP and GLP. It allows you to approve, review and update documents; make changes and identify revision status; control document distribution; and prevent use of obsolete documents, facilitating proper archiving.
In regulated organizations, quality assurance document control is essential to achieving quality and compliance. To control quality, you must control quality documentation, such as SOPs, policies, quality manuals, CAD files, and engineering change orders. QA document control facilitates organizing these vital quality processes.
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A regulated business without a document control system is an invitation to chaos and FDA inspection. ISO quality standards and FDA Current Good Manufacturing Practices (CGMP) presume that both the process and documentation that directs company processes follows pre-approved methods and that any change to these methods is restricted to authorized personnel and tracked for future review. All FDA-regulated and ISO-certified companies are mandated to have a document change control system.
Quality assurance document control is achieved by using a document management system. Document management capabilities boost efficiency and ensure compliance by eliminating labor-intensive tasks like physically routing documents for approval, storage and distribution.
The system must be able to control any document regardless of the application used to create (e.g, Word processing, spreadsheets, CAD, video, audio...)
Having a quality assurance document control process means documents must be managed through their lifecycle statuses of Draft, Released and Archived. (See Figure 2) Lifecycles can be based on document type and need to automatically adjust document security based on lifecycle status.
A secure, time-stamped audit trail of all changes made to any record should be maintained and accessible to the appropriate users and departments. All of this information needs to be automatically captured and secured.Reporting functionality would track past versions, metadata and approval history of the record, from the time it was created until the present.
Documents should be securely stored to ensure only authorized access, while making it easy to protect against disaster.
In manufacturing environments, QA documents complement one another. For example, a form may be associated to a standard operating procedure (SOP), or an equipment manual associated with a maintenance drawing, etc. A document control system should allow document linking to provide users the relevant information needed to do their job.
Reviewed on Capterra
"We have used MasterControl for over 4 years with the Documents, Training and Processing modules in a regulated healthcare environment. With the assistance of the MasterControl implementation team, we customized the application to the needs of 15 Clinical Lab departments, 8 Pathology departments and 9 Hematology / Blood and Marrow Transplant services. We have eliminated the need for bookcases of binders with SOP's and procedures."
Reviewed on Capterra
"People can see and perform what your Sysadmin allow them to. You can audit and report about anything within the system is you are consistent with your naming convention. The Tech Support service is great they are always available and willing to help you."