AWS Professional Services is really ahead of its competition in fielding consultants with life-sciences expertise, who understand not only the technology but also the realities of operating in the regulated world.
Steve Bird Director, Informatics Strategic Marketing, Waters

It’s an achievement any company would be proud of: a software application that solves a critical problem for customers and then earns a reputation for excellence, steadily expands its user base, and achieves industry-standard status.

That’s the story of Waters Corporation’s Empower Chromatography Data Software (Empower CDS). Chromatography—a technique for evaluating the potency and purity of materials that are being studied or manufactured—is crucial to the operations of pharmaceutical companies, biotech firms, and other highly regulated laboratory-dependent organizations. CDS solutions help them capture, analyze, store, and share the huge volumes of generated chromatography data. Since its introduction 25 years ago, Empower Software has been widely adopted by laboratory-dependent organizations worldwide—including all the top 50 pharmaceutical companies—for data integrity, repeatability, and accurate reporting, and has helped Waters attain the market-leading position it holds today.

Waters observed that many of its customers were experiencing rapid evolution in their scientific operations that led to significant challenges related to IT costs, maintenance, and operations. The majority of large Waters customers use on-premises data centers for most IT solutions, including for their Empower deployments, and this kept them from operating as flexibly and cost-effectively as they wanted to.

“Putting Empower—or any other complex software deployment—into production in an on-premises data center can cost millions,” explains Steve Bird, director, informatics strategic marketing at Waters. “There are huge upfront capital costs, gambles on how much capacity to purchase, and ongoing personnel costs for IT maintenance and operations.”

Waters knew that the cloud could address these issues but wondered how best to help its Empower customers unlock the cost savings and other efficiencies available there. Right away, Bird and his team knew that one possibility—offering Empower as a subscription web service—would not appeal to Waters’ regulated customers.

“Changes to Empower would have to take our customers’ compliance policies into account, and a subscription web-service version of Empower would have been too disruptive for those policies,” says Leonard Weiser, director of strategic programs at Waters. The team’s concern about offering Empower as a software-as-a-service (SaaS) model arose from the fact that businesses and organizations in regulated life-sciences industries must comply with extensive government regulations and related Good Laboratory, Clinical, and Manufacturing Practices (GxP). Demonstrating compliance requires documenting that all equipment, facilities, processes, and systems support GxP compliance, a process called “validation.”

The costs of noncompliance—including fines, license revocations, and distribution embargoes on top of the damage to brand equity—can be devastating. If a regulatory health agency expresses concerns about the integrity of laboratory data, the regulated company needs to conduct a wide-ranging investigation and potentially replace existing non-compliant laboratory applications, incurring capital, deployment, validation, and training costs that could be in the order of $200 million for a medium-sized company.

For help showing its customers how to unlock the potential of the cloud without upending their existing validation, procedures, and training investment, Waters turned to Amazon Web Services (AWS) Professional Services consultants. “AWS Professional Services is really ahead of its competition in fielding consultants with life sciences expertise, who understand not only the technology but also the realities of operating in the regulated world,” says Bird.

As a result of its collaboration with AWS Professional Services, Waters released Empower Cloud on the AWS Cloud in January 2018—not as a subscription web service, but packaged as one of the deployment models for Empower 3 Feature Release 4. Empower Cloud functions identically to past versions for the customer, while taking advantage of the power and flexibility of the AWS Cloud. “Customers have the best of both worlds,” says Jeffrey Mazzeo, vice president of marketing at Waters. “With Empower Cloud, the capabilities and user experience are unchanged, but our customers can now realize the cost savings, efficiencies, and security available on AWS.”

Customers can deploy Empower Cloud in their own AWS user accounts, with existing Empower customers incurring no new costs except for any AWS services needed for the deployment. To build new validated Empower instances in AWS, customers use Waters Empower Templates built with AWS CloudFormation to launch the AWS services that Empower Cloud relies on, including Amazon Elastic Compute Cloud (Amazon EC2), Amazon Elastic Block Store (Amazon EBS), and Amazon Simple Storage Service (Amazon S3). Waters Professional Services consultants can provide assistance, such as helping deploy the Amazon WorkSpaces virtual desktops with which Empower Cloud users access the application.

“They can sign on to Empower Cloud from any online computer or device, inside or outside of their organization’s network, using the same Empower credentials they would use at their desks or in their laboratories,” says Bird. “This change significantly enhances their business continuity and data security capabilities while also ensuring their compliance and validation requirements are met.”

By deploying Empower Cloud on AWS, Waters is able to help its customers take advantage of the flexibility and cost-effectiveness of cloud computing—not only for scientific research but also to meet GxP requirements. “Empower Cloud in the AWS Cloud brings global speed and agility, plus flexible integration with external partners, ensuring data traceability and added security,” says Bird. “By deploying Empower Cloud on AWS, our customers know that they can adapt to rapidly changing research needs and still meet their goals for GxP data integrity and computer-system validation.”

Empower Cloud also lowers barriers to entry for customers that lack advanced IT capabilities. “Because AWS resources are so simple and flexible, organizations can take advantage of the power of Empower Cloud without taking on the costs and other challenges of running their own data centers,” says Weiser.

Mazzeo says Empower Cloud will help even more organizations develop new medicines, increase food and materials safety, and perform other vital research. “By offering Empower Cloud on AWS, we are able to deliver even more value to our customers so they can keep making the world a better place.”

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Empower architecture diagram.