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Waters Corp. meets rigorous compliance demands with requirements management

Pharmaceutical, food industry service provider Waters Corp, boasts admiration on recent requirements additions to IBM's Rational software, which has allowed them to go paperless.

Ask Don Cunningham about IBM's recent enhancements to the Rational Software products specifically targeted at engineering teams building complex products with embedded software, and he describes himself as "a kid in a toy store."

It wasn't always that way, said the business analyst, who works in the engineering services group at Waters Corp. When IBM first acquired Telelogic and its products, which the Milford, Mass.-based company has been using for about six years, Cunningham said there was concern about ongoing support and innovation for the tools. "Our business depends on the tools," he said.

But now he has confidence in IBM, is happy about the fact that a lot of Telelogic people are still with the company, and is "excited about a lot of the [new] tools."

Waters Corp.'s road to adopting a rigorous requirements management tool began when the company acquired two companies overseas and set about integrating the development groups. "Rather than three software development groups we wanted one, with collaboration between the groups, sharing, cross training." And, he added, they needed a way to deal with time zone differences.

Waters sells and services products for the pharmaceutical and food industries, which use the instruments for drug research as well as quantitative/qualitative analysis, respectively. Both industries have rigorous compliance requirements.

"We came to the realization that we needed a requirements management tool, a change management tool and configuration management tool all tightly integrated," he said, to facilitate communication around data product design—the software that collects data from the instruments to present to the user. Up to that point, Waters had used separate tools for defect tracking and configuration management, and Microsoft Word to capture requirements.

Cunningham said they chose Telelogic DOORS because of its traceability capabilities, from requirements to code. "It was something we had been asked by a number of customers in terms of audits, to show traceability," he said. "It was difficult to do that with our existing technology. Telelogic makes that a no-brainer."

DOORS also enabled Waters to go paperless, Cunningham said, "which is a key thing for us. Just the logistics of managing paper at remote sites was impossible. Also maintaining a traceabilty matrix between documents was difficult using a paper-based system. DOORS gave us that right out of the box."

Today, Cunningham said there are about 450 people using the DOORS tools in five sites: the U.S., U.K., Germany, Romania and India.

Now with the new enhancements to DOORS Web access, Cunningham said the ability to open access to others in the organization would "really increase the acceptance of DOORS in our organization" and address a hurdle the company has had with sharing requirements documents.

"DOORS Web access and Rational Publishing Engine, I'm very interested in both," he said. "We have a large number of people who want to consume DOORS documents, and we would like to give them access as read only without incurring the full license price. And the publishing engine, the capability is unbelievable in terms of formatting documents and document generation."

For example, he said, with the ability to generate a document to pdf format, they would be able to move that pdf into their SAP software to see a final version. "We are a SAP house," Cunningham said. "Everyone has a SAP license; not everyone has a DOORS license."

"System engineering needs are fairly rigorous to track requirements, and safety is critical in some cases," said Greg Sikes, director of Enterprise Architecture and Systems Modeling for IBM Rational. "You might have teams working together scattered around the world. DOORS now has a very nice Web-based access, and now you can not only consume requirements information, but you can input and edit; so you can make sure all [project contributors] are singing from the same hymnal."

All of the enhancements IBM Rational announced in December are designed to help engineer products with built-in intelligence, Sikes said. "At the heart of the innovation going into these products is software," he said. "The days are gone by when products were made more innovative [just] through different manufacturing techniques or materials; today a lot of innovation is due to software. The companies that make these products have challenges. A lot of them are global, and they may have a different set of partners on a product by product or project by project basis."

Among the announcements, IBM also made enhancements to Rational Rhapsody to increase collaboration between development and quality assurance teams, and improve the specification, capture and documentation of systems engineering designs. And IBM added Japanese as a native language for Rhapsody. In addition, Rational System Architect is now integrated with Rational Focal Point, a product and portfolio management tool.

"We're looking at Rhapsody," Cunningham said, "more in terms of simulation capability. It would be an excellent enhancement to the product lifecycle, to model and exercise it first before committing to code. On the other side, I'm always interested in system architecture, from the standpoint of business processes, to better support your business. If you have a multibillion dollar business, it's a good idea to model the business process so you can see that if something goes wrong, what is the effect? You can have the answers a lot sooner as opposed to reacting to them."

For other organizations looking to implement requirements management and other lifecycle products, Cunningham suggests a phased approach—the opposite of how his group did it. "I'm from New England—I like lobsters. You get a big pot hot and throw everything in. That's kind of what we did: We have the tools, so start using them, and we're going to develop a new business process at same time, so we gave users the opportunity to play with the tools. There were a multitude of things going on at the same time. Having a more phased approach would be better, but in reality that's not the way business works. We made the investment, so let's get the most out of the tools right now."

Implementing requirements management is a big leap forward in terms of knowing what your coverage is regarding requirements and testing, Cunningham said, but he advised organizations not to stop there. "It's a beginning step, but as your business matures you need to continually look at your processes. Business processes are not static. But [requirements management] is a great first step in terms of developing a better process."

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