Everybody's got a problem staying up-to-date with whatever still-wet ink on paper has just been printed to alleviate (or fuel?) an ongoing compliance crisis. Even life science companies have trouble keeping the US Food and Drug Administration (FDA) happy, and that's why they've enlisted the aid of ECM goliath Open Text.
At the Summit '07 conference in Huntington Beach, Open Text announced they'll be introducing a new solution for managing the regulated documents (like new drug or medical device proposals) that life sciences companies manage. The platform will operate in a controlled environment built on Microsoft Office 2007 technologies.
The introduction of this solution is one part of Open Text's ongoing strategy to build universal solutions based on ECM infrastructure technology provided by major platform providers like Microsoft.
To build the solution Open Text drew from its experience with Livelink ECM, a successful Regulated Documents offering that appeared for life sciences enterprises back in 2002.
With experience in the life sciences industry under their belt, they merely expanded on it. And the result is a mouthful: Open Text Regulated Documents for Microsoft Office SharePoint Server 2007. While companies use stock Office apps to manage, review, author and approve content, the content management environment will comply with FDA guidelines like 21 CFR Part 11 regulations.
Microsoft GM of Healthcare and Life Sciences Steve Shihadeh says Open Text uses Office to increase user effectiveness in highly regulated spaces. This is unique among standalone regulated document management applications.
"Because this solution taps Open Text's extensive pharmaceutical and life sciences expertise, it will offer companies using SharePoint Server 2007 immediate productivity benefits by working in a system that is already FDA-compliant, while also stepping up to meet enterprise-wide scalability," he explains.
Indeed, the Open Text system plays well with SharePoint's existing collaboration tools. These include:
* Windows Workflow Foundation
* A document information panel
* InfoPath Forms
* A hodgepodge of content management capabilities
Integrating the strengths of these, rather than working around them, improves complete user experience and enhances productivity instead of just tacking on one more cumbersome compliance step.
Brett Shellhammer, Senior VP of Business Solutions at Open Text, also points out the solution's use of user-supplied metadata information to auto-populate content in a document. It then uses the same metadata for ongoing records management and archiving.
"By building this solution on the 2007 Microsoft Office system, we were able to hide the heavy lifting in managing the complicated workflows and review processes for regulated documents, resulting in a superior user experience," he says.
Microsoft content types typically classify documents and associated workflows so processes referring to each doc type can be easily, consistently followed. This solution is now part of a user's daily experience.
Shellhammer also hopes Open Text Regulated Documents for Microsoft Office SharePoint Server 2007 becomes a universal way of solving similar problems outside the life sciences industry and the jurisdiction of the FDA. "As Microsoft points out in its white paper 'Enterprise Content Management in Regulated Industries,' the challenge of working with Regulated Documents goes beyond the life sciences industry. Our new Regulated Documents solution provides a platform for creating compliant applications."
As 2007 progresses Open Text expects to release additional SharePoint-based solutions for the pharmaceutical and life sciences industries, as well as others.
Open Text Regulated Documents for Microsoft Office SharePoint Server 2007 will be available in March '07.