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5 Questions to Evaluate your Records v. Documents Management Practices

5 Questions to Evaluate your Records v. Documents Management Practices

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,...
Take the Document Control System Quiz (SPOILER: it’s pass/fail there’s no partial credit)

Take the Document Control System Quiz (SPOILER: it’s pass/fail there’s no partial credit)

How do you know your Document Control System is working properly within your medical device company? Take this quick Document Control Health Check-Up Questionnaire: Do you approve (via wet or electronic signature) documents prior to issue? If you use electronic signatures, have you thoroughly assessed their function for 21 CFR Part 11 compliance? Do your document changes go through an approved change control process? Are document changes reviewed by the same person or personnel within the same function who previously reviewed and approved the document? Are your changed documents formally approved again? Do you consistently issue unique revision numbers to documents according to established procedures? Do you consistently document a description of changes to documents according to established procedures?  Are approved documents available at point-of-use for affected personnel? Are documents of external origin identified and is their distribution controlled? Do you effectively prevent the use of obsolete documents? Are your documents backed up to ensure efficient retrieval in the event of disaster? Have you validated your document control process or your electronic document management system as appropriate? If you answered—without hesitation—“Yes!” to all these questions, you are in great shape. Congratulations! If you answered “No” or “Maybe”, or if you had to pause and really think about the answer, then you might need some assistance.   The amount of controlled content created by a medical device company is extensive.  Lack of document control can create regulatory risks, risks to your Intellectual Property, and erodes the value of your operations and assets. Don’t wait for an audit or adverse event to assess and improve your Document Control System. If you need...