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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 About Sparta Systems 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. Sparta Systems maintains an extensive installed base in pharmaceutical, biotechnology, and medical-device organizations.
The Challenge For most of its history, Sparta Systems provided on-premises quality-management-system QMS software to large enterprises.
The company has long helped Cisco systems case analysis 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 GLPGood Clinical Practices GCPGood Manufacturing Practices GMPand 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. 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. That process is error prone, inefficient, and limits the visibility and transparency needed to identify and resolve quality issues.
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. By using cloud services to solve the problem, we can offer a more secure and compliant solution than traditional methods could deliver.
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.
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. 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. 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.
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.
The result is a solution that meets business and compliance needs across the entire technology stack. The Benefits 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. Through protocols represented in the user interface, it guarantees that the controls are continuously enforced.
Log files are monitored. 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.
This automates IT processes, avoids hardware outlays, and eliminates the needs for hands-on infrastructure management.Cisco is the worldwide leader in IT, networking, and cybersecurity solutions.
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