NextDocs Corporation today announced the availability of Version 3.6 of its NextDocs Regulatory Document Management System. Version 3.6 will ship with pre-configured support and full validation documentation for the DIA Electronic Document Management (EDM) Reference Model. In addition, NextDocs provides a complete set of fully-configured sample implementations including folder structures, document types and metadata that embody best practices and standard deployment scenarios. With these innovations, Version 3.6 allows life sciences companies to deploy and validate Microsoft Office SharePoint Server-based document and quality management solutions very rapidly.
“Companies today do not have the time or resources available to start from scratch when implementing solutions for SOPs, regulatory documents or clinical documents, and it does not make sense to do so. Our customers are looking for guidance on implementing standard processes with industry best practices in the shortest amount of time and with the least involvement of resources,” said Matt Walz, the Chief Technical Officer at NextDocs. “With pre-built, sample implementations and ready-to-use validation scripts, Version 3.6 compresses the implementation schedule and allows customers to quickly validate their document management environment.”
“Life sciences firms want to deploy compliance solutions faster and more easily,” said Michael Naimoli, the U.S. life sciences industry solutions director at Microsoft Corp. “With incorporation of support for the DIA EDM Reference Model and a set of sample implementations, Version 3.6 of the NextDocs Regulatory Document Management System provides an out-of-the-box solution that can be implemented far more efficiently than traditional, legacy document management systems.”
“The DIA Reference Models represent a common approach to implementing regulatory and clinical content management solutions by standardizing system specifications and configurations,” said Chet Shemanski, Director of Product Management, NextDocs. “NextDocs is committed to helping our customers adopt the standard taxonomy provided by the reference model by providing pre-configured document inventories, metadata models, lifecycles, workflows and other artifacts that are in direct alignment with the Reference Model.”
The DIA EDM reference Model is an initiative being driven by a DIA committee driven by the belief that, according to its charter, “that the time has come for our industry to develop a taxonomy/metadata reference model for electronic document management.” NextDocs is a strong supporter of the initiative, because it allows customers to leverage a standard set of structures rather than developing their own information structures.
NextDocs (nextdocs.com) is the worldwider leader in providing Microsoft Office SharePoint Server-based document, quality and compliance management software for life sciences companies. By taking advantage of the built-in functionality in SharePoint and adding the needed functionality for process, workflow, auditing, document portability, NextDocs provides leading edge and innovative solutions to meet the changing needs of Life Sciences companies.
Designed specifically for life sciences, NextDocs is fully 21 CFR Part 11 compliant and adds features to SharePoint necessary for common business process functions and regulatory compliance. All of this is accomplished in an Internet/Extranet environment, to mirror the way companies collaborate and exchange content in today’s IT environment.