QUALITY MANAGEMENT REGULATIONS FOR MEDICAL DEVICE MANUFACTURERS SET FORTH BY THE FDA REQUIRE THE ESTABLISHMENT AND MAINTENANCE OF DOCUMENT CONTROL PROCEDURES FOR DOCUMENTS ISSUED TO COMPLY WITH QMS REQUIREMENTS.

Document control is a set of policies and procedures designed to ensure that there is organizational accountability for documents that are used to satisfy quality requirements at medical device companies. When the FDA's document control mandate is followed as set out in 21 CFR Part 820.40, processes for document approval, distribution, and changes help ensure that everyone working at a medical device company has access to the most up-to-date versions of the documents that are required to effectively and consistently implement the manufacturer's quality processes.

WHAT ARE THE FDA DOCUMENT CONTROL REQUIREMENTS?

The FDA requires that each manufacturer of medical devices establish and maintain procedures to control all documents that are required by 21 CFR Part 820. The document control requirements apply to every document that lives in the QMS. The FDA identifies three main aspects of document control that must be established:

  1. Document approval - Medical device companies must designate a person (usually the quality manager) who will "review for adequacy and approve prior to issuance all documents established to meet the requirements of 21 CFR Part 820." Document approval should include the date that the document was reviewed along with the signature of the person that reviewed it.
  2. Document distribution - Approved documents that make up the QMS must be available at every location where they are used or necessary, and all obsolete documents must be removed from all points of use to avoid any instances of unintended use of old or outdated documents.
  3. Document changes - Any changes to documents in the QMS must be reviewed and approved by a person in the same function or organization that performed the original review unless specifically designated otherwise. Medical device companies also need to keep a record of changes to each document as they happen over time, including a description of each change, what documents are affected, the date and signature, and when the change takes effect.

HOW DO DOCUMENT CONTROL REQUIREMENTS BENEFIT MEDICAL DEVICE MANUFACTURERS?

Medical device manufacturers can benefit significantly from following the FDA guidelines for document control. An established document approval process creates accountability - the quality manager is responsible for approved documents that are in the QMS, and each document in the QMS must be approved by the quality manager.

The guidelines for document distribution ensures that documents are kept up-to-date throughout the organization, not just within the QMS itself, and the guidelines for document change ensures that companies can track any changes that happen within the QMS, including reverting to an earlier version of a document if required.

GREENLIGHT GURU HELPS MEDICAL DEVICE COMPANIES AUTOMATE DOCUMENT CONTROL

With a paper-based QMS, document control is an incredible hassle. Approved documents end up in a filing cabinet where they are inconvenient to access, physical copies must be made to facilitate the distribution of approved documents, and document changes are impossible to manage because there are numerous copies of the old documents floating around everywhere.

Greenlight Guru's Quality Management Software for medical device companies creates a single source of truth for everyone at your organization. With paperless, cloud-based document storage and built-in document controls, each document in your QMS can be monitored for its approval status, changes can be tracked over time, and employees always have access to the most recently updated versions when required - no scavenger hunts. Best of all, you'll pass with flying colors when the FDA audits your QMS for document control procedures.

Are you interested in learning more about our Quality Management Software? Let’s take Greenlight Guru on a demo.

See the Demo