Guides Help Organizations to Prepare Regulatory Content Submissions Using Structured Content Management Best Practices
AARHUS, DENMARK and KING OF PRUSSIA, PA – 9 September 2015 – DitaExchange™ announced today the release of DxTemplates™ for Life Sciences to enable organizations in this highly regulated industry to quickly build key regulatory submission documents using Dx4™ and structured content management (SCM) best practices.
DxTemplates for Life Sciences help companies prepare regulatory submission documents for Modules 2, 3 and 5 of the Common Technical Document (CTD). Since its inception in 2003, the CTD has revolutionized the regulatory review process, led to harmonized electronic submissions, and enabled implementation of good review practices. It has also eliminated the need to reformat the information for submission to the different ICH regulatory authorities. DxTemplates guide authors by providing the required topic components and maps that are used to create the final regulatory submission.
“Life Sciences companies world-wide adhere to the ICH standards and submission guidelines. By using DxTemplates, they can start developing content for submissions immediately, drastically reducing start-up time while following industry best practices,” commented Jim Nichols, vice president, DitaExchange.
DxTemplates operate on the Dx4 Structured Content Management (SCM) Platform. Dx4 is an SCM solution that enables organizations to develop and store key content as components that can be written once and used over and over again across the organization.
“Creating regulatory documentation is at the heart of every Life Sciences organization. While much of the information required for submissions can be re-used, traditional content management solutions hinder this practice because information is stored within them as complete documents,” commented Nichols. “SCM enables users to develop and store content as components that can be approved and pulled into submission documents as needed, opening the door to true re-usability.”
Dx4 runs on the SharePoint platform – on-premise or in Microsoft Office 365 and Azure and uses a Microsoft Word interface extending the use of current technologies that many organizations are already using. Dx4 enables organizations to create and store content in a componentized way so that it is infinitely re-usable with the ability to consistently publish anywhere in the format recipients require.
DitaExchange is committed to simplifying the way regulated organizations create, manage, share and deliver important content though structured content management solutions that are built to run on the SharePoint platform. A leader in Structured Content Management, DitaExchange is a privately held company headquartered in Denmark with locations around the world. For more information, visit www.ditaexchange.com
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