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.