This important addition to the Total Regulatory Solutions portfolio enhances regulatory submissions operations
Standalone submissions-viewing tool gives diverse user groups real-time access to content generated and stored on multiple platforms.
CSC Life Sciences has announced the release of TRS Viewer, a multi user,Web-based solution for viewing electronic Common Technical Document (eCTD), non-eCTD submission (NeeS) and volumized PDF-based applications and publications. Part of the recently rebranded Total Regulatory Solutions (TRS) suite, TRS Viewer is a standalone utility for enabling any user with access rights to view regulatory submissions content — irrespective of how or where the content was created.
This important addition to the Total Regulatory Solutions portfolio enhances regulatory submissions operations, as life sciences organizations increasingly look to phase out paper-based submissions in response to demands by national and international regulatory authorities.
The Web-based TRS Viewer provides the ability to view in progress those submissions that are in eCTDXPress as well as final submissions, whether they’re located on a file share platform or held within commonly used document management and collaboration systems, based on Documentum or Microsoft SharePoint, including FirstDoc and FirstPoint. Key features include intelligent search and views of selected sequences or all sequences across the life cycle of a submission. Submissions can also be viewed by market, related products or other required groupings. Both electronic and NeeS or paper submissions can be viewed and navigated.
Electronic dossiers not only are requirements now but also present opportunities for considerable operational efficiencies for life sciences organizations. By enabling submissions to be collated, processed and approved more swiftly and accurately, this reduces the associated administrative overhead and expedites a companies’ speed to market with new products.
With the TRS suite, CSC offers companies a comprehensive, integrated portfolio of end-to-end solutions for business processes around the creation, review, approval, consumption and exchange of regulated content.
“The challenge of achieving and maintaining regulatory approval and compliance is becoming increasingly complicated, time-consuming, inefficient and expensive,” said Marty Magazollo, Solution Practice Director of the Life Sciences Software Solutions Group at CSC. “Those challenges must be faced at the same time as the industry attempts to deal with declining R&D productivity and the imperative to optimize the product portfolio in both existing markets and newly emerging international markets. With the increasing pressure on pricing and reimbursements, ever-higher regulatory hurdles and stronger competition, it becomes clear that a solution as comprehensive as TRS is timely and needed.”
Coupled with TRS’s innovative technology and a range of flexible delivery options — including a software-as-a-service proposition — CSC offers complementary business services solutions comprising business process outsourcing that enables clients to shed costly, tedious and time-intensive regulatory operations businesses so that they can focus on their core business activities.
CSC is a global leader in providing technology-enabled business solutions and services. Headquartered in Falls Church, Virginia, CSC has approximately 93,000 employees and reported revenue of $16.2 billion for the 12 months ended July 1, 2011. For more information, visit the company’s website at www.csc.com
Carina Birt, Sarum PR
PR for CSC Life Sciences
+44 1722 411150
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