Pharmaceuticals and Biotechnology
Enhance safety and scalability with proactive quality and information management
Accelerate Digital Transformation in Quality
Why the top pharma and biotech companies choose Sparta
Top global brands rely on Sparta’s deep expertise and depth of quality management solutions with TrackWise Digital and TrackWise to bring products to market faster and simplify the complexity of managing quality across the supply chain.
Quality is our foundation. Sparta’s reputation for delivering quality management solutions and expertise to meet rigorous standards in the heavily regulated pharma and biotech industry is unparalleled.
TrackWise and TrackWise Digital set the standard for enterprise and digital quality management systems.
Leverage our Quality Process Accelerators (QPAs) for rapid value and process harmonization built on over 25 years of experience and best practice recommendations from our customer councils.
THE DIGITAL QUALITY EDGE
Connect quality across the value from the lab to the patient. Leverage advanced digital technologies – cloud, AI/ML and IoT for actionable, real-time insights and speed time to market.
Increasing complexity and a growing network of external suppliers require a smarter QMS with advanced digital capabilities to optimize processes, increase yield and rapidly scale up or transfer production lines to support factories of today and of the future.
Stakeholders and virtual supplier can collaborate on the latest quality documents and events with anywhere, anytime access using our cloud and mobile-enabled QMS.
Arbor has been able to improve both timeliness and efficiency with TrackWise Digital. The company has significantly reduced the length of time that change requests remain open with its CMOs.
“The availability of the system is fantastic,” says Emily King, All the change records are at our fingertips now. The search capability is our favorite feature; it’s much more robust than our old QMS. Plus, we can configure and customize TrackWise Digital workflows to meet our exact needs.”
Key QMS Capabilities
Investigate OOS and document results and initiate actions with integrated workflows.
Handle deviations and CAPAs in a centralized location, along with associated investigations, approvals, and resulting records.
Fully integrated CAPA system with automated routing, notification, delivery, escalation, and approval capabilities.
An integrated tracking system and a powerful workflow engine that automates audit findings, responses, corrective actions, approval, and reporting.
Manage changes from requests, through pre-approvals, change execution, follow-up approvals, and implementation.
Built-in templates comply with ICH Q9 to manage risks throughout the entire product lifecycle.