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The release of v3.6 of NextDocs (news, site) Regulatory Document Management system continues the company’s move towards establishing itself as the principal provider of document management systems for the Life Sciences.

It comes with pre-configured support and full validation documentation for the DIA Electronic Document Management (EDM) Reference Model.

Targeting Life Sciences with DIA

The DIA (Drug Information Association) Reference Models represents a common approach to implementing regulatory and clinical content management solutions by standardizing system specifications and configurations.

This new version also comes ready to install with a full set of implementation samples including folder structure, document types and metatdata.

In effect, it is a ready-to-use MOSS based document management system, which the company says can be up and running in the time it takes you to say – as NextDocs consistently remind us – ‘Built in SharePoint’.

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NextDocs Regulatory Document Management system
 

So what is it that you get? First of all, NextDocs builds all their products using SharePoint. They then extend its functionality and features to satisfy the individual needs of businesses operating in highly regulated industries, including those regulated by the Federal Drugs Administration (FDA).

And they do it very quickly. “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,” said Matt Walz, the Chief Technical Officer at NextDocs.

V3.6 For Life Sciences

The result is a document management system applicable to clinical documents (v3.5), or life sciences (v3.6). Features include:

  • Complete Document management from creation to destruction
  • Major and minor versioning
  • Task logs that track every activity performed
  • Check in and check out controls
  • Configurable document numbering.

Worried About Compliance?

Meanwhile, if all the talk of regulatory compliance is making you nervous, then NextDocs is holding a webinar this week as part of their Compliance Without Complexity Seminar Series.

The webinar is entitled Beyond Compliance: Connecting CAPA and Quality Processes with SharePoint.

For those that don’t know CAPA stands for Corrective Action and Preventive Action. Corrective Action is based on a non-conformance event that has happened in the past. Preventive Action is based on preventing a non-conformance event in the future.

Sign-up on the NextDocs website if you think it is for you.