Until recently, pharmaceutical researchers took notes and kept records in spiral-bound notebooks. The result? A tedious, inefficient and expensive system in which research data was effectively lost once books containing data were filed away. In response to customer demand, Milford, Massachusetts-based Waters Corporation, already an innovator in the design of laboratory equipment, started working with Oracle. The goal? One suite of products set up and ready to go, that provides compatibility, interoperability and scalability. The result? A service-oriented architecture based on Oracle Application Server and Oracle Database 10g and utilizing Waters' products, that provides a stable, secure environment in which researchers can capture, index, search and share data.

As Published In November 2005

Business Elements
By Karen J. Bannan

Precision measuring tools from Waters help customers refine their products—one ingredient at a time.

When a child is born, that child, to its parents, looks as close as you can get to a perfect baby. But sometimes even the most beautiful baby may have physical problems that are not readily apparent.

Genetic defects are at the root of serious metabolic disorders that, if left untreated, may cause long-term complications or even death. Today, every state in the U.S. and most developed nations offer or require newborn screening programs that ferret out hidden illnesses, such as phenylketonuria (PKU), hypothyroidism, and cystic fibrosis. All that is needed is a single drop of blood and access to equipment called mass spectrometry instrumentation to find these genetic needles in a haystack.

"We are in the business of making tools for the separation sciences, where you put a product onto one of these instruments and it will separate the sample into its component pieces," explains John Swallow, principal engineer at Waters, the world's leading manufacturer of tools for mass spectrometry. "For example, if you took something like a can of soda—say, orange soda or something—and you put it into our instrumentation, it would separate out the flavors, sugars, and additives and tell you the concentrations of each," he says.

When that same technology is applied to a drop of infant blood, the chemical and genetic material that make up that new human being are open for scrutiny—potentially saving lives.

In June 2005, the Milford, Massachusetts-based Waters embarked on a collaboration with PerkinElmer to create, deliver, and support advanced newborn screening tools that will be increasingly in demand as states increase the number of required screenings. Today, some states screen for only two disorders, while others check for more than ten. But those numbers are expected to go up as testing becomes easier, more accessible, and less expensive.

The new Waters screening product joins a long line of Waters products designed for the laboratory space—such as highly sensitive tools that measure contaminants in drinking water, detect performance-enhancing drugs in athletes and impurities in food, and assist in the purification of drugs. All of the company's products strive for the same goal—to turn raw lab data into results that are usable.

At Your Service

What does this mean for the consumer? A lot, explains Swallow. In the real world, for example, when a consumer has a cold, he or she might head over to the local drugstore and pick up an over-the-counter cold medicine. Years ago, if consumers were given the choice between a name brand and a generic version, they probably grabbed the name brand, perceiving it to be of higher quality.

Today, as more and more daily prescription drugs—such as allergy medicine Claritin and heartburn medication Prilosec—are sold over the counter and there are more and more generic prescription drugs available, consumers are more confident in choosing the generic equivalent, says Swallow.

"The ability for the generic companies to put out a quality product that is quality checked, relative to the name brand products, using probably the same software that the name brand pharmaceuticals use, and being able to present this data to the FDA, allows the general populace to have a choice as far as feeling confident in the products that they see on the shelves."

Bottom line: Consumers now have better choices, some of which can save them money.

Science for Fun

Waters customers are also using their technology for nonmedical applications as well. While the majority of Waters customers are part of the pharmaceutical market, increasingly other industry sectors are reaping the benefits too. For example, a global soft drink manufacturer uses Waters technology to analyze its soft drinks, helping the company find the perfect balance of sweet and refreshing flavors. Company employees go out and visit the many retail stores that sell their products, buying sample bottles and cans from each location. Once they have accumulated a broad sample size, they run the soft drink samples through a Waters spectrometer—a product that performs structural analysis—analyzing the samples for content balance and identifying the component parts. The machine breaks down a soda and returns the exact amount of each ingredient that's been mixed in. This is important because there are many different bottlers across the country, each licensed to make soft drinks according to a prescribed recipe and each relying on different ingredient suppliers and employees to come up with the final beverage. With so many different variables, there's always a possibility of making mistakes.

"The soft drink company compares the samples' spectrometer readings to the company's standard," explains Swallow. "They pay the bottlers based on how close their products are to the perfect product, which encourages them to produce a uniform soft drink." This means that consumers can count on their favorite drink tasting the same whether they are in New York or California or somewhere in between.

Making the Grade

Often, Waters customers have needs addressed before they even know about them, says Swallow. In September 2003, the U.S. Food and Drug Administration (FDA) announced a new initiative called 21 CFR Part 11 (or Code of Federal Regulations Title 21 Part 11), which is designed to modernize the regulation of the pharmaceutical manufacturing industry. Part of this initiative requires stringent adherence to the maintenance of electronic records and signatures.

Waters recently added a component to its product called NuGenesis SDMS (Scientific Data Management System). With Oracle's help, Waters was able to make any Microsoft Office document fully searchable and part of the overall data warehouse related to a drug trial. By laying a template over individual documents creating metadata out of each field, users could search any field in a printed report. The same concept extends to incoming faxes.

This means that pharmaceutical drug trials—at least on the paperwork side of things—may go more smoothly than they have previously. For example, if a doctor faxes back a company- supplied form, it is immediately fed into an e-fax machine where it can be stored digitally in the data warehouse. This makes the document instantly searchable and secure. "It never goes to paper," says Swallow. "It is loaded into the data warehouse automatically, so that you can search against results."

The same process happens with forms or documents that are e-mailed or created by anyone related to the study. "If I had an Excel spreadsheet or something, I would put it in a location that says I want this to go to the warehouse. The data transport engine would poll all of the different systems that it was told to look at, and it would grab the data automatically and insert it into the warehouse," says Swallow.

These functions make record-keeping more exact. There's never a worry that a signature or document is lost or unaccounted for, because everything is not only in the database but also searchable. Researchers have an electronic paper trail, and there are fewer chances for data entry mistakes, since the only human interaction comes from a document's originator. And the security features inherent in Oracle Database also ensure that the data is secure from unauthorized access.

Helping Hand

Customers are also reaping the benefits of a new Waters innovation called eLab Notebook Software, a collaboration tool that simplifies laboratory processes and progress. A few years ago, chemists and researchers would take notes the old-fashioned way: using a pen and a spiral-bound notebook. As work progressed, observations, test conditions, chemical structures, and details about compounds were jotted down. Every so often, the book would be submitted to a laboratory manager who would review the book, sign off on it, and return it to its original owner. All of the work that went into the book was the intellectual property of the company; so when the book was filled, it would be taken down to the corporate library and placed on a shelf along with volumes and volumes of other lab notebooks.

This system was ineffective for a variety of different reasons. Most important, researchers couldn't share information, and searching for data was nearly impossible. "If somebody said, 'Well, did anybody ever do any work on some compound that was kind of like this,' or any similar question that you would want to look back [at], it was a lost cause," says Swallow. "In truth, the probability is that the knowledge is going to be lost, since nobody is going to sit and go through hundreds of notebooks looking for a piece of information that may or may not be there."

The eLab Notebook, which is based heavily on core Oracle technology, takes a researcher's notes and makes them fully searchable. It also indexes information from a company's data warehouse, allowing users to cross-reference data for more-efficient research and development. It also keeps users from losing something that could potentially benefit thousands or millions of people, says Swallow.

You Gotta Have Friends

According to Swallow, Waters started working with Oracle in the early 1990s for one reason: All of its customers were Oracle database users. Overwhelmingly, he says, they were asking for compatibility and interoperability. There was no other option since, without software, the end users simply couldn't do their jobs the same way.

Snapshot Waters www.waters.com Location: Milford, Massachusetts-based Waters creates high-performance liquid chromatography, mass spectrometry, thermal analysis, and rheology products and services. 2004 revenue: US$1.1 billion No. of employees: 4,200 Oracle and partner products and services used: Oracle8i Database, Oracle9i Database, and Oracle Database 10g; Oracle Fusion Middleware

"If I were doing sugar analysis and I didn't have any software and I had to do it all manually, I'd run it through the machine and it came out with a peak [result] of a given size," says Swallow. "Then I would turn around and say, 'OK, I know that that weighs this much.' Then I would run the sample and weigh the paper again on the unknown. Having the weight of a known, I could do a calculation that says that all of these things are equal," he explains.

Sound confusing? It would be, and time consuming, too.

Today, all Waters applications are based on a perfect mesh of Oracle technology, such as Oracle Application Server and Oracle Database 10g, and Waters' own instrumentation and analysis software. At least in the case of Waters' chromatography technology, one couldn't address all of the end user's needs without the other. Waters, says Swallow, has a clearer development path because of the integrity and solid product development at Oracle. These characteristics—especially the stability of Oracle development—also help Waters sell its own products.

"The scalability of the Oracle product allows us to manufacture a single code base for our product, with a single instance for the data acquisition component, the data warehouse component, and the electronic laboratory notebook component," says Swallow. "The big plus for the customers then is that, whether they have one Waters product or the entire suite of Oracle products, they're already there, set up, and ready to go should their business needs change."

For More Information Oracle Solutions for Life Sciences Oracle Database 10g Oracle Fusion Middleware

Oracle's technology vision is also helping Waters with its own software innovation. Waters is following Oracle's example as it moves forward, moving from client/server to service-oriented architecture (SOA), where Waters applications are Web services that can be accessed from any type of computing product. This is especially significant in the pharmaceutical market, since PDA and wireless technologies are becoming the standard in the laboratory setting.

"We'll be able to, using the Oracle Workflow Engine as an example, take a look at [chromatography] results in real time and then determine if something is out of specification by setting an alarm to your PDA," says Swallow. "You'll be able to see the issues in real time, and then be able to address that so that you can have the concept of being able to do more with less. Individual chemists and analysts at different companies could manage a larger number of instruments."

By virtually enlarging the number of studies and research, Waters, in conjunction with Oracle, is changing the world and benefiting humankind one molecule at a time.