Feature-Rich, Integrated Quality, and Regulatory Compliance Management Software for Biopharmaceutical Companies

Abstract: Sparta Systems' TrackWise quality and compliance management software (QMS) helps global biopharmaceutical companies reduce risk, achieve compliance, and lower costs. TrackWise streamlines processes by improving visibility, traceability, and accountability through structured workflow, escalation and reporting.

Methodology: TrackWise enables highly regulated organizations to implement their own custom-configured, web-based, integrated tracking systems without requiring any programming or changes to the database schema. TrackWise is an all-in-one solution that manages any type of quality, regulatory, or proprietary business process, including, but not limited to: deviations, audits, observations, change control, complaints, adverse events, regulatory commitments, CAPA, training management and employee qualification, and EH&S Incidents.

Configuration: Point-and-click configuration tools enable the TrackWise administrator to create an unlimited number of user groups, user-defined fields, workflow rules, security permissions, system flags, and notification rules. TrackWise utilizes Universal Time Code (UTC) for global time synchronization and supports an unlimited number of languages. TrackWise Integration Manager allows integration with existing enterprise systems, including ERP, EDMS and ECM, LIMS, and MES.

Workflow Engine: The TrackWise workflow engine automates complex business processes and removes non- value-added activities. Workflows can follow a serial or parallel processes based on application requirements. TrackWise provides a mechanism to automate and track the activities that are part of these processes.

TrackWise Dashboard: The Dashboard allows users to view, organize, and perform tasks, while providing managers a highly effective overview of compliance status across the company. Users can launch reports from their Dashboard to track open items such as tasks due or pending approvals.

Querying and Reporting: TrackWise querying features make finding information fast and easy. Any query can be used to send data into a validated report template. Reporting capabilities provide the ability to display simple information in summaries and tables, and detailed information in a hierarchical parent-child report.

Document Management: TrackWise Document Management software enables organizations to manage controlled documents in a secure repository. SOPs, engineering specifications, device history records, investigation and lab documents, supplier quality records, and other objects may be maintained and versioned electronically in accordance with industry best practices.

Training Management: TrackWise Training Manager enforces compliance requirements by effectively managing training curriculums, employee profiles, and their respective training histories and requirements.

Solutions for Emerging Companies: Sparta offers cost-effective, turnkey compliance solutions for biotechnology and pharmaceutical companies based on the same core TrackWise product. Companies can take advantage of TrackWise's powerful features and pre-configured workflows developed from best practices to enable rapid deployment cost effectiveness.

Conclusion: TrackWise addresses all areas of quality and risk management as an integrated system that relates events and actions, automates workflow and facilitates closure of compliance related issues.

Company info

Sparta Systems

Holmdel Corporate Plaza

2137 Highway 35

Holmdel, NJ 07733

Tel: 732.203.0400

Fax: 732.203.0375

Email: sales@sparta-systems.com

Website: www.sparta-systems.com