Regulatory Document Management: The First Step in Passing any FDA Audit

FDA audits can be one of the most terrifying and stressful events that a clinical research organization may encounter. Audits can quickly sneak up on the unsuspecting research organization. A staggering 77% of all FDA warning letters are in response to inadequate or insufficient records and consent documentation. Maintaining records to stay compliant and well prepared for an audit is now more important than ever.

As research organizations of all sizes slim down, trying to do more with less, the opposite is happening in terms of regulation. In recent years, clinical researchers have seen, and will continue to see, increased scrutiny and regulation in the clinical trials arena. With each passing regulation comes more documentation that needs to be managed and, in turn, more can slip through the cracks.

The management of documents, specifically regulatory documents, including IRB approval letters, consent forms, approved protocols, 1572 forms and dozens of others need to be tracked and stored in an organized manner. For many research organizations, this is no easy task. Boxes of paper take up every inch of storage space, or worse, researchers pay for document storage services which can lead to confidentiality concerns and an additional level of HIPAA compliance requirements. On top of all of that, there is no easy way to sort through the piles of paper.

Digital document management tools, similar to those found in CTMS or EDC systems, can be the diamond in the rough that so many researchers need. These types of tools allow for centralized management of documents and allow researchers to associate those documents with each study that an organization is conducting. When a research organization does get that dreaded letter from FDA saying they will be performing an audit, researchers can sleep easy knowing they have everything they need just a mouse-click away. In many cases, users are able to print an inventory list of documents to easily determine which documents are missing or which documents need revision. In many CTMS or EDC systems, documents can be viewed directly within the application no matter where the user is located.

The best way to ease the anxiety of an impending FDA audit is to simply be prepared. Properly storing and tracking your regulatory documents will go a long way in helping to maintain your state of constant readiness.

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