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Liquent Regulatory Solutions for Life Sciences

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Liquent InSight® Foundation: Electronic Document Management Fully Configured with Industry Best Practices
 
By combining our extensive experience in life sciences document preparation and assembly with leading document management system (DMS) technology, Liquent is proud to offer a solution for organizations looking to gain firm control over their intellectual property: InSight Foundation.

As part of the InSight Suite , InSight Foundation is an electronic regulatory DMS (ERDMS) designed specifically for regulated content. It differs from a standard DMS because it is pre-configured with industry best practices and is delivered validation-ready, providing companies with a lower cost, rapid implementation alternative to highly customized document management solutions.

InSight integrates seamlessly with Liquent's proven, market-leading publishing solutions like CoreDossier, EZsubs, as well as the full suite of InSight products for next-generation publishing and complete lifecycle management.

Business Challenges
Regardless of whether you have one or multiple products in development, your organizations’ document production will reach high volumes. Emerging guidances such as the Electronic Technical Document (eCTD) increase the importance of having a firm control over regulatory documentation.

The challenges you face or will begin to face in the future include:

> Creating, gathering, assembling and tracking a high volume or wide-ranging documents
These documents may have been generated over years, in various formats, using various applications, by internal and/or external authors and stored in multiple repositories. This disparate environment is perhaps the biggest business driver for a DMS and also the biggest challenge for implementation.

> Securing and Standardizing Content
For optimum return on investment, one must empower authors, contributors and reviewers with DMS access across your organization but must also ensure that well defined security and consistent methods for content creation and review is in place.

> Integrated Publishing
Your controlled content must be readily available to submission management and publishing tools, so seamless integration between them is paramount.

> Meeting Regulatory Requirements
Life Science organizations are under increasing pressure to conform to agency requirements and audits when managing CRFs, SOPs, and submission ready documentation.
Standards such as the CTD/eCTD are fundamentally changing the way in which one must deal with documentation requiring a firm control over naming conventions, attribute capture, numbers of document types and more. Standard EDMS solutions will not be able to provide this level of control.

InSight Foundation is the only solution that combines validation-ready document management technology with industry best practices, providing you with a Web-enabled system from the beginning.