12 July 2012

Regulatory Submissions: Filling the Critical Gaps in EDM Systems - By Patricia Santos-Serrao

It's been said that electronic document management (EDM) systems for the management of submission documents are "a dime a dozen." However not all EDM systems are created equal, at least not when it comes to the management of final submission documents. Many of us are familiar with the standard functionality that most EDM systems provides particularly in the life sciences space such as: document types, taxonomy, version control, lifecycle management, securities, PDF rendering, watermarks, and electronic signatures just to name a few.

Although the challenges of migrating from paper-based submissions to electronic are numerous, they are also subjective based on a company's current infrastructure and culture. The top challenges faced by a pharmaceutical or biotech company looking to transition to electronic common technical document (eCTD) format for regulatory submissions often include: select a vendor / solution, configure system to support specific needs, train users on system, and roll-out/implement the tools.

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