Rather than just capturing point-in-time results, the service-oriented nature of the AWS platform allows validated workloads to be continuously monitored, audit trailed, and secured for compliance. 
Bruce Kratz Vice President of Research and Development

For 20 years, Sparta Systems has been helping customers bring products to market safely and efficiently by delivering quality-management software solutions that provide control and transparency throughout both the enterprises and their supplier networks. Based in Hamilton, New Jersey, with locations across Europe and Asia, Sparta Systems offers platforms for ensuring the products and services of its customers—mostly life sciences companies—adhere to processes that conform to standards of the U.S. Food and Drug Administration (FDA) and other agencies around the world. Sparta Systems maintains an extensive installed base in pharmaceutical, biotechnology, and medical-device organizations.  

For most of its history, Sparta Systems provided on-premises quality-management-system (QMS) software to large enterprises. The company has long helped its customers in the life sciences industry—among other regulated industries—with the tools to help achieve and maintain compliance for GxP-regulated workloads.

The term GxP encompasses a broad range of compliance-related activities such as Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), and others, each of which has product-specific requirements that life sciences organizations must implement based on the type of products they make and the country in which their products are sold. When life sciences organizations use computerized systems to perform certain GxP activities, they must ensure the computerized GxP system is developed, validated, and operated appropriately for the intended use of the system.

Sparta Systems delivers QMS software solutions that are vital to product development and production. To help its customers comply with the regulatory requirements of agencies around the world, Sparta Systems offers TrackWise, a quality management system that is deployed on premises in an enterprise IT environment. The solution guides customers in executing quality processes such as recording deviations, identifying root causes, documenting corrective and preventative actions, and mitigating recurrences by implementing improvements.

TrackWise customers include the top 50 pharmaceutical companies and the top 20 to 30 medical-device companies. Of its 700 on‑premises implementations, 100 are for billion-dollar companies. Until four years ago, TrackWise was the core product offered by Sparta Systems.

As pharmaceutical companies have increased their work with external suppliers and contract manufacturing organizations (CMOs) across the world, their risk has increased. In the eyes of the FDA and other regulatory authorities, a mistake anywhere in the production ecosystem is ultimately the responsibility of the primary manufacturer. This expands the problem of quality management beyond a single company.

“The traditional quality systems in place at CMOs are separate and disconnected from the manufacturers they serve,” says Mark DeBellis, director of cloud operations at Sparta Systems. “Many of them rely on manual intervention and the transposing of data via fax and email. That process is error prone, inefficient, and limits the visibility and transparency needed to identify and resolve quality issues.”

Sparta Systems sought to create a solution that could help companies extend quality management to their production networks and remain connected throughout the manufacturing life cycle. Because the company wanted to exchange quality data securely across a distributed network of companies while allowing quality professionals to collaborate efficiently, cloud technology was an obvious choice.

“I’m still amazed how many life sciences professionals believe you can’t run a GxP workload in the cloud,” says Bruce Kratz, vice president of research and development at Sparta Systems. “The fact is that regulations do not dictate what technology must be employed. By using cloud services to solve the problem, we can offer a more secure and compliant solution than traditional methods could deliver.”

Several years ago, Sparta Systems began to look for a cloud provider to be the foundation on which to build the company’s vision for a quality business network. This platform would serve as a collaboration solution that would incorporate quality, security, and data integrity into the entire life science production network in a cost-effective and scalable way.

Sparta Systems decided to run its Stratas quality management platform on Amazon Web Services (AWS). “A lot of our customers in the biopharma and medical-device industries had already started to use Amazon for GxP and non-GxP workloads,” says Kratz. “That history is meaningful. We believe AWS is well ahead of its competitors when it comes to working with life sciences industry leaders to ensure their services meet regulatory scrutiny.”

The company’s cloud-based Stratas platform is an organizational ecosystem called the Quality Business Network. It comprises Stratas Quality Management, which enables organizations to manage and report on quality-related activities, and Stratas Supplier Collaboration, a data communication network that extends quality processes to suppliers, CMOs, and partners.

The Stratas QMS platform is scalable and highly secure. It connects distributed quality systems with a patent‑pending messaging format that makes it easy for its customers to communicate with entities in their supply-chain networks. Because life sciences organizations are required to maintain records and logs needed as GxP evidence, Sparta Systems standardizes data and employs automated AWS monitoring and validation tools. It protects quality data by using a layered security strategy and assigning controls available with AWS to safeguard data integrity.

The Sparta Systems solution eliminates the points of disconnect found in traditional methods of managing a pharmaceutical quality process across the globe. It picks up where the TrackWise on‑premises solution ends—by replacing email, fax, and paper-based data exchanges to and from suppliers with an electronic system that digitally captures all steps and delivers them to the system of record anywhere in the world, in the cloud or on premises. Supported quality processes encompass incident management, investigation, change control, corrective and preventative action, and complaint handling, to name a few. This whole-ecosystem approach promotes compliance and collaboration in real time.

New and enhanced AWS services, coupled with a compliance-aware approach, have lowered the barrier for regulated industries to bring their mission-critical systems to the cloud. Third-party auditors conduct assessments of AWS controls regularly, with compliance reports on each regulation made available to customers. When designing its platform for the AWS Cloud, Sparta Systems mapped its GxP application requirements to AWS service specifications and SLAs.

“The incredible pace of innovation at AWS is a big reason why we are able to achieve our goals on that platform,” says Kratz. “With that superior provider for our cloud infrastructure taken care of, we can concentrate on what we do best and apply our 20 years of experience in quality management to a new breed of solutions.”

The relationship between AWS and Sparta Systems highlights the success of a shared responsibility model that takes advantage of the expertise of both companies. The result is a solution that meets business and compliance needs across the entire technology stack.  

The benefits of moving to a distributed quality system connected through a highly secure cloud platform include and extend beyond scalability, flexibility, and cost. The Stratas Quality Business Network can help a company modernize to match the distributed nature of its business. In adopting the AWS Cloud, with its global reach, Sparta Systems resolves the challenge of managing process transactions across multiple companies by applying end-to-end traceability and security.

To test its cloud-based QMS platform’s efficacy, Sparta Systems conducted a study in which participants using the solution were able to reduce the average life cycle time needed to address quality-compromising events from 137 days to 66 days—a 48.2 percent decrease—over a two-year period.

“Stratas provides transparency across the worldwide quality ecosystem, which ultimately enables our customers to maintain the highest standards for their important lifesaving products,” says Kratz. ”Rather than just capturing point-in-time results, the service-oriented nature of the AWS platform allows validated workloads to be continuously monitored, audit-trailed, and secured for compliance.”

By standardizing business transactions, the platform facilitates using data for benchmarking, fine-tuning business processes, and responding to regulatory investigations. “Our collaboration network on AWS can support machine learning and data analysis on data aggregated throughout a customer’s partner ecosystem,” says Kratz. “Such data-sharing features replace inefficient relics such as email and fax.”

Instead of using documents, the cloud platform captures information in coded digital workflows, which essentially enforces users to comply with regulatory policies. Through protocols represented in the user interface, it guarantees that the controls are continuously enforced. “Audit readiness is a strength of a networked cloud solution,” says DeBellis. “Time-stamped audit trails are generated. Log files are monitored. Metrics are tracked. The AWS Cloud platform stands up to rigorous scrutiny. In fact, our customers audit our offerings to make sure we meet the same standards they must meet.”

The company employs AWS services to manage its infrastructure as code, meaning that it uses a high-level descriptive coding language to provision the infrastructure it obtains from AWS. This automates IT processes, avoids hardware outlays, and eliminates the needs for hands-on infrastructure management.

Because of the automated and multi-tenanted nature of the cloud solution, Sparta Systems needs only 25 percent of the time it took with on-premises implementations to set up and administer the platform for a customer. “We do it once and everybody benefits,” says Kratz.

Sparta Systems now has new customer opportunities with midsize life sciences organizations that previously could not afford to deploy on-premises QMS software to manage their quality processes. For emerging biopharma and medical‑device companies, it’s now possible to integrate with a supplier ecosystem and exchange cogent quality data that addresses compliance needs.

“AWS is doing important work in the life sciences community,” Kratz says. “It has liaised with leading life sciences organizations, evangelized the validated workload, and distributed case studies and white papers. These are the proof points that give our customers confidence that they can take advantage of advanced technologies without jeopardizing their standing with the regulators.”

Learn more about AWS and life sciences compliance.