EMC Addresses Regulatory Communication Concerns in New Solution

September 16, 2014

Applied Clinical Trials

EMC announced Documentum Submission, Store and View, for simplified storage, search, and retrieval of submission documentation and all associated correspondence...

As part of the EMC Documentum for Life Sciences Solution Suite, EMC announced Documentum Submission, Store and View (SSV), for simplified storage, search and retrieval of submission documentation and all associated correspondence, which adheres to security and compliance regulations.

Documentum SSV links regulatory correspondence and communications to submission files, enabling a 360-degree view of regulatory activity. It also automatically stores electronic common technical documents (eCTD), non-eCTD electronic submissions (NeeS) and paper submissions into a scalable Documentum repository that delivers advanced security, audit trail, metadata and indexing capabilities.

In a conversation with Applied Clinical Trials, Lori McKellar, Director, Market Development, and Steve Scribner, Principal Consultant, both with Life Sciences at EMC, told us that the solution can be hosted or on-premise and offers leveled access controls for the sponsor and their affiliated regulatory representatives. Further, Scribner explained the need for a full-view of the regulatory communications as sponsors simultaneously file multiple submissions to different global regulatory authorities, primarily through local affiliates, a contracted service. “The sponsors and CROs need this local expertise. Submissions aren’t the same for each country and the affiliate carries on that level of detail,” said Scribner. The danger is that the agency will communicate to an affiliate, and that information will be misunderstood or not make it in a timely fashion to the sponsor.

More specifically, EMC Documentum SSV enables:

  • Regulatory submission and associated communications storage in a compliant and secure repository that includes audit trails and indexing for more efficient tracking of submissions and queries and a complete view for better clarity and understanding with regulatory authorities.

  • Easy access and view of regulatory correspondence that’s linked with submissions, which includes an out-of-the-box integration with Microsoft Outlook and follows a best practice document taxonomy for submissions and agency correspondence.

  • Quick search and retrieval of archived submissions and associated documents using a faceted navigation on metadata properties such as product, country, manufacturer, submission type and date.

  • Streamlined viewing of eCTD, including the full regulatory submission lifecycle, and even the navigation of inter-document hyperlinks.

Read the full release on their blog here.

 

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