A GPS for Life Sciences: New Tools for Navigating the Information Management Highway

The life sciences industry is defined by its regulated content—massive volumes of regulated content.

With CRO, CMO, and HMO relationships extending the enterprise, information is multiplying faster than ever before. It’s being viewed on every mobile device imaginable and accessed from locations across the globe. So how should life sciences organizations find, control and maneuver through this flood of information? And still be compliant?

Latest enhancements to EMC Documentum Quality & Manufacturing (Q&M) and EMC Documentum Electronic Trial File (eTMF) solutions have you covered. These advancements further enable life sciences organizations to efficiently meet compliance requirements, increase productivity, and securely collaborate across the extended enterprise.

Just like a GPS can help you navigate quickly and efficiently to your destination, Documentum Q&M and Documentum eTMF, can do the same for control and regulated content.

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Here’s how:

Choose your settings and pre-programming upfront.

Do you want the most direct route or avoid highways? The same type of “upfront” work can be done in your organization to help personalize the user interface or navigate the set-up of clinical trials.

Part of the Documentum for Life Sciences solution suite, the newly enhanced solutions are built on the Documentum content management platform and leverage the latest EMC Documentum D2 client to maximize productivity.

Users can now personalize workspaces using the integrated client as easily as selecting a setting on your GPS.  With its modular layout and widget-based approach, users can personalize what information they view and how they view it.

Dealing with a complex clinical trial? Users can now easily define, maintain and process large, complex file plans using interactive and intelligent Microsoft Excel spreadsheets. In addition, file plans can be managed at the product, trial, country and site levels, and logically combined with the file system when the clinical trial is activated.  It’s that simple.

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Program your destination.

Is the address pre-programmed into your GPS? What’s your final destination? Maybe it’s an approved standard operating procedure (SOP).  If so, pre-program who within your organization needs to review and approve the document. Using the latest Documentum Q&M, organizations can easily automate the management of SOPs and process controlled documents through automated workflows across the enterprise.

Your final destination may be ensuring all necessary documentation is collected in order to complete the eTMF. Documentum eTMF now provides reusable file plan templates, including conditional and product-level artifacts, to ensure consistency and efficiency across clinical trials.

Arrive on time.

Arrive at your destination with the right settings and address programmed into your GPS. Similarly, Documentum Q&M and Documentum eTMF combine auditing and reporting support for compliance. New search capabilities leverage faceted navigation and the taxonomies and dictionaries of DIA reference models, enabling users to quickly locate and ensure the right documents are produced. What is the benefit of your solutions if they can’t ensure compliance and inspection-readiness?

Now that we are safely at our destination, let’s hear your thoughts on how life sciences organizations are navigating the information management highway.

About the Author: Rohit Ghai