by Annemaria Duran

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The need to accurately maintain and retrieve documentation is one of the most vital aspects of business. Your documents have to reflect the fact that you are developing products to meet design controls, managing risk, and maintaining a compliant a system.

Failure to accurately document and maintain your documents can have substantial repercussions. When the FDA is involved, if you can’t find the documentation, or if didn’t document your processes, then it didn’t happen.


Let’s review some critical aspects of maximizing the efficiency and effectiveness of document management:

  • Develop a Strategy and Best Practices for Your Documents: Start immediately, or at least early on. The sooner you start, the easier it will be later when you have to find your documents. Look at your existing documents and create an organized structure that your documents can be segmented into. This will help employees to maintain a uniform filing system and to know how to file and name documents. A uniform filing structure will save you hours of time and will help to eliminate lost documents. While you are creating your structure, you should spend a little time and define how documents should be named and which documents should be filed under each folder. That eliminates similar types of documents finding their way into diverse folders. If you use a document management system, identifying the folder structure, the predefined names, and the organization of your documents can be pre-programmed to avoid mistyping of names, rouge naming structures, and other filing headaches.

Some of the common categories that medical device companies will find are: device history records (the evidence of manufacturing builds), complaints and customer feedback, corrective actions, non-conformance, and change orders.

In addition, you will need to determine what the retention is for the various documents and will want to document the timelines. A document management system will automate this process by allowing you to program the retention guidelines and automate the tracking of those retentions.  Additionally, you should identify whose responsibility the various documents are so that documents can be applied to a workflow and avoid being forgotten about after filing.

  • Go Paperless. Stop Using Paper. This may sound redundant, but too many companies go paperless and then continue to initiate their processes in paper, only to convert them later to electronic format. Although that is a step in the right direction, by moving to a completely paperless system, lost documents are drastically reduced. 25% of misplaced paper is never found! By going paperless, you are able to utilize electronic search functions to find even misfiled documents. Further, by going paperless and utilizing a document management system, you can abide by CFR 21 part II easier. Read about how a document management system can help you more easily stay compliant with CFR 21.


About eFileCabinet

Since 2001 eFileCabinet has been an innovator in electronic document management software.  eFileCabinet provides document management software for over 150,000 users and continues to innovate new tools and features that make document management simple and that enhance business growth. As the recipient of multiple awards, eFileCabinet is committed to helping you to do more! For more information about eFileCabinet, please fill out the form on this page.