DIA EDM Reference Model
Nov 2, 01:42 PM
By now most of the individuals reading this blog are familiar with the DIA EDM Reference Model, for those of you who aren’t here is a little summary.
Last year, in 2008, The Drug Information Association (DIA) organized a committee made up of industry professionals to come together and develop a best practice model for Electronic Document Management (EDM). This committees goal was to define the minimum set of metadata (also referred to as attributes) to enable searching and reuse capabilities for regulatory submission, particularly for CTD documents. This “reference model” addressed best practices not only around metadata but also document types and taxonomy. The document types are broken down into your standard CTD categories such as Clinical, Nonclinical, Quality/CMC as well as Regulatory documents such as Safety (Pharmacovigilance), Labeling and Regulatory Administrative documents.
Many of your organizations may have an EDM with a configuration for submission documents such as many of our QUMAS customers who have implemented the “QUMAS R&D Configuration” which closely resembles the EDM Reference Model and has been offered to our clients since 2006. For those companies who have already implemented an EDM system with a configuration there is no need to panic and feel that you now need to make changes to your configuration. This is a best practices model for industry, not a requirement from a regulatory agency. However if your organization is in the process of implementating an EDM now or is shopping for an EDM system the reference model is a great guide to assist you in the configuration of that system.
Many EDM vendors have announced that their products incorporate the model which is great, but more importantly how difficult or simple is it to make a change to that model. The EDM Reference Model is not written in stone, and neither are the CTD metadata requirements, we are all familiar with the emerging and future trends in electronic submissions including Regulated Product Submission(RPS) therefore change are these changes will impact how your system is configured thought out the years. Questions like:
- Can the EDM Reference Model in the EDM System I purchase/implement be configured easily?
- Can the configuration change be made by our IT group internally or must we pay the vendor to come in and make the changes for us?
- How much validation will be needed to make simples change to the configuration?
QUMAS offers an EDM Reference Model configuration. For more information or a demo contact us at info@qumas.com.