The Role of the EDMS in the Regulatory Submissions Process

As someone who works for a vendor who is heavily focused on enterprise content management and who has significantly increased its market share in Life Sciences over the past 5 years, I am keenly aware of the increasing importance of tight integration between eCTD tools and the document management repository. Pharmaceutical and Biotechnology organizations are no longer satisfied with passive integrations between the technologies, and are driving vendors to make significant enhancements to the ways the two systems work together.

In addition, the requirements for eCTD submissions are being driven back into document management systems; document preparation, assembly and quality control are functions that need to be supported within the EDMS. A high-level of granularity, document cross-referencing, and parent-child relationships, although important in the past, have increasing value in the preparation of electronic submissions. And issues like submission sequence archiving are now a standard expectation for any EDMS.

As electronic submissions requirements evolve so will technologies that support them. I expect to see a strong importance placed on the EDMS in the preparation of “submission-ready” documents and greater cooperation between eCTD and ECM vendors over the next 3-5 years.