What is Document Control in Medical Devices?

Document control refers to the procedures and methods that an organization has in place to manage the required documents and records during all the stages of the product life cycle. It includes the process of creating, approving, sharing, and archiving said documents.

Why is it Important to Have Document Control Practices in Place?

Effective document control helps in improving the process of auditing and inspection by making the appropriate versions of documents accessible to the right personnel. It lies at the crux of the Quality Management System(QMS)and is critical to demonstrate compliance with Regulatory requirements. Quality System Requirements (QSR) as per 21 CFR 820 and ISO 13485:2016 both have well-defined requirements for document management.

What are Document Control Requirements as per QSR (21 CFR 820)?

Subpart 820.40 of 21 CFR 820 describes QMS requirements for document control in detail.

820.40a of 21 CFR 820.40 details requirements related to document approval and distribution, such as:

  • Designation of an individual(s) to review for adequacy of documents before issuance.
  • Documentation of approval, including the date and signature of the approver.
  • Availability of documents required for this part at all locations for which they are designated, used, or necessary, and removal of obsolete documents from all points of use or prevent them from intended use.

820.40b of 21 CFR 820.40 details requirements related to document changes, such as :

  • Changes to documents are reviewed and approved by an individual in the same function or organization that performed the original review unless specifically designated otherwise
  • Communication of changes to appropriate personnel in a timely manner
  • Maintenance of records of changes to documents
  • The change records must include a description of the change, identification of affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective

What are Document Control Requirements as per ISO 13485:2016?

ISO 13485:2016 details the control of documents in 4.2.4. The documented procedures be developed to:

  • Review and approve documents for adequacy prior to issuance
  • Review, update as necessary, and re-approve documents
  • Ensure that the current revision status of and changes to documents are identified
  • Ensure that relevant versions of applicable documents are available at points of use
  • Ensure that documents remain legible and readily identifiable
  • Ensure that documents of external origin, determined by the organization to be necessary for the planning and operation of the quality management system, are identified and their distribution controlled
  • Prevent deterioration or loss of documents
  • Prevent the unintended use of obsolete documents and apply suitable identification to them

It is evident that both standards have quite a few key similarities, such as:

  • Standardization of documents across the organization
  • Maintenance and availability of updated documents at points of use
  • Appointment of relevant personnel by management for review and approval

What are Some of the Common Errors?

Some of the common errors that medical device organizations make, as evidenced in the FDA inspection reports, are:

  • Documents were not reviewed and approved by the designated individual(s) prior to issuance
  • Document control procedures have not been adequately established
  • Records of changes to documents were not adequately maintained
  • Documents were not available at all locations for which they are designated, used, or otherwise necessary
  • Documents that were obsolete were observed at a location where they are being used

How can an Organization Minimize Errors?

  • Having SOP for document control with detailed and non-ambiguous instructions
  • Training of the personnel involved in the SOPs
  • Keeping up-to-date with changing Regulatory requirements
  • Traceability and quick retrieval of documents
  • Remove obsolete documents from points of use

It is apparent from the discussion that document control is one of the crucial aspects of a QMS(Quality Management System), and efficient document control practices serve as proof that the devices are safe and efficacious for use.

For more information and insights regarding document control and other aspects of quality management, consult or schedule a call with our Regulatory experts.