Is SharePoint Ready to Manage Controlled Content?

Microsoft SharePoint has a lot of momentum as an emerging enterprise content management (ECM) alternative. Since the release of a major upgrade in 2007, it is clear that SharePoint is ready to move beyond its limited role as a basic intranet and collaboration platform and into the content management arena. As a result, IT planners and executives are updating their enterprise content management strategies to determine the role for SharePoint in their ECM architecture.

It is much less clear whether SharePoint is ready to take on the especially challenging demands of managing enterprise content for pharmaceutical companies, which is subject to extensive regulation by the FDA and other health authorities around the world. The requirements for managing pharmaceutical “controlled content” are extensive and specific, and to date have been the focus of more specialized and extensive platforms from companies such as Documentum, OpenText and others. So the real question for the IT leaders at pharmaceutical companies is whether SharePoint is ready to take on that role.

For many organizations, this is not yet a pressing decision. Their initial plans for SharePoint are to use SharePoint to access – but not store and manage – controlled content. In this supporting role, SharePoint is positioned as a front-end for an ECM architecture that includes a more robust back-end ECM repository. This approach takes into account the ease-of-use of SharePoint for end users, and its effective integration with Microsoft Office, while leaving the “heavy lifting” for the traditional ECM products. It can also provide a very comfortable starting point for companies starting to work with SharePoint.

Use of SharePoint as a front-end can make a lot of sense, especially in cases where there are a large number of users of the content who simply need to search and access documents but not edit or approve them. And there are several connectors and data replication tools on the market to facilitate data exchange between SharePoint and traditional ECM platforms to facilitate this architecture (From Wingspan and EMC, for example), and this approach avoids the whole question of whether SharePoint has all the required capabilities to manage controlled content, since its role is limited to search and retrieval.

But what if you want to use SharePoint to manage and store, not just access, regulated content? Is it up to the task? The answer is a qualified yes, and the qualification is only that while SharePoint by itself may not address all the requirements for managing regulated pharmaceutical content, SharePoint-based solutions certainly can.

The pharmaceutical industry operates in an intensely regulated environment that often results in application requirements that go beyond what is easily addressed by SharePoint. Some examples of requirements driven by regulations such as 21 CFR Part 11 include complex versioning schemes, comprehensive electronic signature and audit trail requirements and controlled printing configurations.

To address these types of additional requirements, system designers may find they either have to extend the SharePoint platform with customized functionality or supplement SharePoint with additional tools or applications. The good news is that such tools and applications are now readily available, which is an indication that the whole partner ecology around SharePoint as an Enterprise Content Management platform is maturing rapidly as vendors rush to fill functionality gaps and address special requirements such as those in the pharmaceutical space.

Recognizing the market potential for SharePoint-based solutions and realizing that there are remaining gaps in SharePoint for managing regulated content for life sciences companies, software vendors have stepped in to fill the gap. With tools and applications that embed the required functionality directly in SharePoint, they deliver the extended functionality needed without breaking the fundamental SharePoint user experience.

Two of the leading contenders in this space are NextDocs, a young Pennsylvania company with a complete set of SharePoint applications specifically for managing regulated content, and First Consulting Group, with its FirstPoint product suite. These systems offer the great advantage of having all the required functionality to address typical requirements for managing controlled content as well as being preconfigured with appropriate document types and workflows for specific application areas such as managing Standard Operating Procedures and managing Submission Content.

The NextDocs solution is architected to directly extend the SharePoint environment and architecture. That approach preserves the benefits of SharePoints ease of use and integration with the familiar Microsoft Office environment. While adding the specific capabilities needed by pharmaceutical companies for controlled content. In addition, the NextDocs approach results in a very small IT impact and footprint since it works within the SharePoint architecture.

With the emergence of SharePoint as a viable ECM platform, life sciences companies are evaluating its role in their enterprise content management architecture and strategy. Some will determine that SharePoint’s role should be initially limited to accessing content stored in other environments, and there are tools available on the market to address that requirement. But some companies will determine that they are ready to make the move to using SharePoint to manage and store their regulated content, and for those companies, it is encouraging that the market is responding with solutions targeted specifically at managing controlled content in pharmaceutical companies.

About Ken Lownie, Glemser Technologies Corporation

Ken Lownie is the Chief Operating Officer at Glemser Technologies, located in Bethlehem PA. He is a frequent speaker and writer on topics relating to enterprise content management. Glemser Technologies designs and implements structured content solutions for pharmaceutical companies. Glemser offers proven, off-the-shelf solutions for pharmaceutical labeling, SOP management and promotional materials management as well as delivering full lifecycle projects for its clients. Find out more at www.glemser.com.