Seamless EDMS Integration

The new ISI Solutions Platform is designed to help Life Science organizations make their regulatory applications more interconnected and interoperable. Through integration with DMS, documents compiled in the earlier stages of the drug life cycle can be used at later points in the submission process—automatically. Experience seamless integration with document management systems as you leverage the flexibility of integration without having to alter your existing processes.

To respond to the changing electronic landscape and organizations’ growing needs to simplify and streamline collaboration within their drug development process, ISI continues to be at the forefront of the regulatory publishing industry with the release of its integration with SharePoint Server 2007. The ISI Regulatory Solutions Suite (RSS) of eCTDXPress, ISIPublisher, and VLM offers a seamless, out-of-the-box integration with Microsoft Office SharePoint Server 2007 (MOSS 2007) that capitalizes on the benefits of SharePoint Server while providing truly refined publishing benefits for pharmaceutical and biotech companies.

ISI RSS/Sharepoint Server 2007 Integration highlights include:

• Browse SharePoint sites from within RSS
• Drag and drop from SharePoint to RSS
• Associate documents from SharePoint to RSS at the version level
• Visually differentiate SharePoint files from traditional files in the RSS building process
• Use SharePoint Columns and Content Types to create efficiencies in the submission building process
• Set file names and node titles
• Automate eCTD building process
• Automate creation of submission structures, including Study Tagging Files
• Place completed documents and publications into SharePoint sites, and navigate hyperlinks

FirstDoc Integration
Create and view eCTDs directly from FirstDoc’s FDRD environment. You’ll be able to drag-and-drop files directly into eCTDXPress, and conveniently generate “where used reports”.

Documentum and LiveLink Integration
Map your existing Documentum and LiveLink attributes to eCTDXPress to allow for appropriately specified metadata, such as file titles, study IDs, etc. This also enables the automatic tagging of study files and generation of STFs.

For even more control, you can also map specific values for attributes to match regional nomenclature (due to different spellings in EU and US). For example, if “synchronisation” is a value typically used in a file-title attribute, that can be mapped to change automatically to “synchronization”.

Finally, you can map eCTDXPress attributes to Documentum or LiveLink for archival and map any attribute to custom eCTDXPress attributes. eCTDXPress ensures that attributes being used as part of business processes in an EDMS remain intact. Browse repositories directly from eCTDXPress’ built-in file browser, drag files, import and archive from both.