Sound Document Management Lays the Groundwork for Life Sciences Regulatory Publishing

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Published 12 May 2011 | By QUMAS

When publishing a dossier, life sciences companies typically struggle with efficiently compiling supporting documentation. Usually, this is the result of dealing with paper and electronic documents, legacy versions and incomplete or inaccurate data due to human error. This does not need to be the case. To prevent documentation from becoming a costly issue, companies can take steps (on the front end and throughout the entire document lifecycle) to enable a smooth submission process.

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R&D Submission Documents Package QUMAS offers a number of Packaged Solutions providing pre-defined and pre-tested configurations of Document content management or Process management for specific, common industry problems. This Package addresses document management requirements around documents used in Global Regulatory Submissions, particularly CTD and eCTD submissions. The pre-defined configuration supports the creation, approval, and ongoing lifecycle management of documents used in functions such as Clinical, Nonclinical, Quality, Manufacturing, Regulatory Affairs, and Safety. Products

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