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TrackWise is a web-based tracking software tool for electronically logging, managing, and trending quality and compliance issues

and action items in accordance with cGxP standards. With its ability to centralize quality processes into a single, integrated system, TrackWise helps organizations increase efficiencies and achieve compliance by integrating related events and actions, automating workflow, and facilitating trending and reporting across quality systems. TrackWise is operating in over 150 organizations and has over 200,000 end users. The system provides all of the necessary features to implement 21 CFR Part 11 requirements. TrackWise was developed with the vision that all business organizations will benefit from using a versatile, powerful, and off-the-shelf management and tracking tool that is highly user-configurable. Highly regulated industries, such as pharmaceutical, biotechnology, medical device, food, and chemical, are faced with the need to accurately manage, track, and trend a vast number of quality (GxP) issues, such as deviations, investigations, out-of-specifications, corrective and preventive actions (CAPA), change control, complaints, audits, observations, commitments, Sarbanes-Oxley controls, environmental health and safety issues, HACCP and others. Managing, tracking and electronically routing these types of issues and actions requires a cross-functional and interdepartmental approach, as process management functions extend across the supply chain.

Key Features
Flexible: TrackWise is licensed as a single platform with the inherent ability to manage any type of

quality, regulatory or proprietary business process. There is no limit to the number of applications that TrackWise can manage. This unequaled extensibility out-of-the-box allows applications to be deployed systematically based on business criticality. Automated: From the time action items are logged in, to the time they are closed, TrackWise provides a

mechanism to automate and track the different activities that are part of this process. Authorized users can view activity histories and quickly determine not only the current state of a problem, but also who is involved and what has been accomplished within the process. TrackWise workflow tools automate and enforce both serial and parallel workflow processes. The system provides ad hoc query capabilities, as well as dynamic reporting to provide users with up to date information. Configurable: TrackWise is fully configurable to meet diverse, business-specific needs, enabling

organizations to implement their own custom-configured tracking system without requiring any customization of source code or changes to database schema. By design, a centralized

database can be divided into an unlimited number of organization-specific Divisions (site, division, department) and application-specific Projects (Complaints, Deviations, Corrective/Preventive Actions). This allows an organization to track as many types of issues, in as many sites as necessary, using a centralized software platform and database. One system manages all applications without requiring the separate purchase, installation, or validation of separate components. Each tracking application and organization area can employ its own workflow process and business rules without impacting other workflows. The built-in point-and-click configuration tools also enable the TrackWise administrator to create an unlimited number of user-defined fields, configure pr