How do you know your Document Control System is working properly within your medical device company?
Take this quick Document Control Health Check-Up
- 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
- 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
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 help or lack the resources to even assess the state of your current Document Control System, MethodSense can help. We have developed On Call Quality Support specifically to turn your Document Control “No” and “Maybe” answers into “YES!” Because it’s critical that you effectively maintain your compliance and protect your critical content. For more information, contact Jeff Whitt, Director of Business Development.