TrackWise, is a QMS software tool implemented by over 75 FDA-regulated companies for management of cGxP issues. Tracking applications include management of Corrective and Preventive Actions (CAPA), Customer Complaints, Deviations/Nonconformance, Investigations, Change Control, Audits and Observations, Regulatory Commitments, and many other quality process issues. Today, TrackWise is recognized as the de-facto standard for management of quality issues in the FDA-regulated arena, and is being used successfully by the industry to meet the requirements for cGxP, FDA, and other Regulatory Authority requirements.
TrackWise is used by the industry as a one-stop solution for tracking all quality issues. By way of design, TrackWise is a fully user-configurable system that enables our customers to configure an unlimited number of projects, e.g., workflows, using a single centralized database. This facilitates centralized implementation of all the above mentioned applications, and addresses all specific regulatory and business requirements in a user friendly and effective manner.

Using TrackWise, all departments, such as Quality Assurance, Quality Control, Regulatory Affairs, Customer Relations, Research and Manufacturing have an efficient way to access all relevant issue and action item data in real time. From the time records are logged in, to the time they are resolved, TrackWise provides an easy-to-use mechanism to track the different activities that took part in this process. Authorized users can view the activity history and quickly determine not only the current status of a problem, but also exactly who is involved and what has been accomplished.

Key Benefits:

Completely configurable - enabling your organization to set-up TrackWise to mirror your workflow process and business rules without requiring any code changes

Ability to manage an unlimited number of tracking areas for ALL quality management needs without the need to purchase additional software or additional modules

Reduced validation efforts and validation costs: Using one software solution, rather than purchasing and implementing separate software or modules for CAPA, customer complaints, change control, and other quality applications saves time and dollars. Further, configurable software requires less validation efforts than customized software

Proven solution for FDA-regulated companies - with an estimated 90% market share, TrackWise has become the industry accepted and proven solution to help organizations meet their compliance requirements

Quality - Sparta Systems internal quality systems are based on GMP processes. The company has been audited by nearly 40 FDA-regulated customers, and has passed 100% of its audits. Sparta Systems has also passed a PDA-based audit which is on file in the Audit Repository Center.

Rapid implementation - Experienced professional services group with over 75 major implementations in validated environments

Integration to other systems ERP, MES, LIMS, and others