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Documents, documents everywhere.  But which are the records, which are documents—what is the difference and why does it matter?

Even start-up medical device companies are neck deep in documentation.  In addition to documents generated during the creation and production of a product or combination device, additional documentation is generated while working with the FDA Q-Subs, submissions, and Quality System Regulations. No question about it, it’s daunting….and often misunderstood. 

One common confusion we hear frequently is the difference between a “document” and a “record”, and how each should be managed.  Keep reading for insights into the difference between the two and best practices to help you manage each.

1. Documents vs. Records:  What’s the Difference?

In short, records are a subset of documents. More specifically:

Document: For a medical device company, a Document satisfies a regulatory need or requirement and is most often called a “Controlled Document.”   A Controlled Document is a reference document, which through the course of its lifecycle may be reviewed, modified and distributed several times. Controlled Documents may include documents and information for public disclosure including, but not limited to, marketing, sales and promotional materials, training materials, clinical and technical information, labeling, and product related documents such as manufacturing procedures.

Record:  For a medical device company a Record is a document created to demonstrate both quality system conformance to specified requirements and the effective operation of the Quality Management System (e.g. Change Requests, CAPAs, etc.).  They are documents that provide objective evidence of activity performed, or results achieved, during the design, development and production of regulated product(s). This can include verification, validation data sheets, DHR records, etc.  A Record may be in any form (e.g. paper, photographs, & electronic media) and serves as evidence for the FDA that a company complies with FDA Quality System Regulations.

2. How should you handle controlled documents?

  • Documents should be reviewed for adequacy and approved prior to issuance.
  • The approval, including the date and signature of the individual(s) approving the document, should be documented.
  • Documents should be available at all locations for which they are designated, used, or otherwise necessary.
  • All obsolete documents should be promptly removed from all points of use or otherwise prevented from unintended use.
  • Changes should be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise.
  • Approved changes should be communicated to the appropriate personnel in a timely manner.
  • Each manufacturer should follow Change Control processes and maintain records of changes to documents.

3. How Should you Handle Records?

  • Records need to be maintained and be reasonably accessible for review by regulatory authorities during inspections.
  • Records must be legible and stored to minimize deterioration and prevent loss.
  • Records stored in automated data processing systems (i.e. electronically) must be backed up.
  • Records deemed confidential may be marked as such to aid FDA in determining whether information may be disclosed under the public information regulation.
  • Records required by 21 CFR Part 820 must be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer.
  • Europe has different retention periods, per EU Medical Device Directive and Medical Device Regulation.

4. Paper V. Electronic Handling of Documents and Records:  What’s the difference?

For Paper Documents and Records:

  • Use locked, fire-safe, and water-resistant file cabinet storage. In some cases, humidity controls are also necessary.
  • Have controls for checking documents in and out, and records to ensure that nothing gets lost and that the most current version is used.
  • Have designated individuals with keyed access to file cabinets.
  • If you choose to outsource to external parties, you should perform supplier qualification to ensure the vendor meet your quality standards.

For Electronic Documents and Records: 

  • Your electronic document management system should be validated and 21 CFR Part 11 (US) or Annex 11 (EU) compliant.
  • Ensure that you have an infrastructure sufficient to support the installation of an e-document management system.
  • Ensure backups are configured and validated.
  • If you store documents in a cloud environment, you should qualify the supplier to ensure that vendor meets your quality and security standards.
  • You should ensure system training is performed for all system collaborators.

5. Who is Responsible for Maintaining Controlled Documents and Records?

  • Document Control Representative: person(s) responsible for the issuance, routing for review and approval, filing and change control of documents.
  • Management: responsible for the review and approval of documents.
  • Process Owners: responsible for the review and approval of documents.
  • Subject Matter Experts: responsible for providing input on their subject matter area, reviewing and approving documents.

When it comes to good practices for medical device company Controlled Documents and Records, just about everyone has responsibilities and they need to conform to established processes.  In our experience, these kinds of responsibilities often and unintentionally take a back seat to the hard work required for company growth, design work, R&D and selling products. Consequently, we frequently see these processes and good practices falter, leaving the company exposed to risk from the FDA auditor or, even worse, a deterioration in product quality.  

If you need help or lack the resources to properly maintain you Controlled Documents or Records, MethodSense can help. From establishing systems from the ground up to turning Record lapses into auditable results, we’ve helped clients at all levels.  For more information, contact Jeff Whitt.

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