The Single Source of Truth - Pharmaceutical Executive

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The Single Source of Truth
The regulatory load thrust upon pharma's shoulders in recent years has made compliance solutions a top budget priority for IT executives, and sent technology suppliers on a mission to uncover for pharma companies


Pharmaceutical Executive


In some cases, companies with substantial experience in other industries are adapting their products for pharma's needs. Take, for example, MRO Software, which provides asset-management solutions. The company, whose name stands for the industry abbreviation for "maintenance, repair, and operations," has its roots in heavy manufacturing, such as the auto industry. "All of the welding arms in GM plants in North America are tracked in our database," says Vaughn Harring, MRO's director of public relations. "We know, for example, that these motors need to be replaced every ten thousand or hundred thousand welds. At the right time, up pops a plan on the system. It says, 'We've got to replace the motor in this welding arm on this machine. Here are the parts required. We need a mechanic and an electrician.' Our system talks with the various other systems in the company."

The advantage of using technology to run such manufacturing-related functions as maintenance and calibration is that a computer system like MRO's Maximo Enterprise Suite can bring together a wide variety of information and place it at the disposal of the people who have to do the work. When the system flags a piece of machinery for maintenance, for instance, it can deliver blueprints, drawings, parts lists, maintenance records, and standard operating procedures directly to a laptop or handheld device. Because it is crucial to deliver only the latest, approved version of documents, Maximo, like many compliance-oriented software tools, has been designed to work with standard document management systems. "We interface with Documentum for more generic documents," says MRO's Eric Luyer, manager of industry marketing for global manufacturing industries, "but we do have interfaces with typical engineering documents, drawings, or blueprints of buildings or facilities, or engineering documents with the full details of an asset. We work with partners who are really focusing on those types of applications, and we are working on a strategic level to build integration between those tools."

In other cases, companies are partnering with ERP vendors to develop products that add pharma-specific features to existing systems. For example, content management is a key area for most pharma companies. The industry relies on a large number of documents that relate to compliance: standard operating procedures, recipes, clinical trial results, marketing materials, and many others. It is crucial for companies to be able to control who can change these documents, to track and archive versions, and so forth. Increasingly, companies are using electronic content management systems, such as Documentum, to do the job. But Documentum is industry neutral; it needs to be customized by building in best practices and document types, for example. Several companies have been developing software products that sit on top of Documentum, and adapt it to specific industry needs.

One of the most elaborate add-ons is FirstDoc Enterprise Suite, developed by First Consulting Group (FCG). FCG has been working as a consultant to the industry in deploying content management systems since 1993, and about five years ago decided to take what it had learned and turn it into a software tool, FirstDoc. The product has components for R&D, clinical trials, GMP manufacturing, marketing and sales, and medical information services, to ensure that specific document types are handled appropriately. "For example," says Sarah Powell, FCG's director of product strategy, "let's say you're in the clinical area. You write a clinical protocol, and it has been approved and distributed to your investigators. At that point, if you need to change it, the best practice is not to just modify that document but to create an amendment to it. We've put amendment functionality into the repository that allows them to do that in an automated fashion as opposed to in a manual fashion."

Converging Islands "In the past, says SAP's Sabogal, "pharmaceutical companies in particular have basically gone the route of individual IT islands. They have a different solution to R&D versus manufacturing versus financials. And now, as you try to roll these things up together, it gets to be a technology challenge that is quite expensive. So IT executives are really going to think what kind of investment they have to make now, so that two years from now, when the FDA is asking for pedigree information, they're in a position to deliver it.


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