Stay on track

Sparta Systems provides a centralised solution for enhanced quality management for life sciences organisations. European managing director Yaniv Vardi explains the significance of the software for pharmaceutical companies.

TrackWise® is enterprise quality management QMS software that enables companies to ensure compliance, improve control, reduce risk and lower costs by consolidating the management of quality and compliance issues and actions, automating workflow and facilitating trending and reporting.

How can TrackWise help pharmaceutical companies with GRC?
The development and production processes in the life science industry requires companies to implement meticulous procedures to ensure compliance with global regulatory authorities and with internal SOPs. Often these procedures are in the form of error-prone, paper-based models, point –solutions, making it difficult for companies to reconcile and monitor pharmaceutical quality across more complex global supply chains.

Streamlining these processes, proactively identifying root causes of these quality issues and reducing the cost of compliance while maintaining the highest quality standards is a top priority. For example, Menarini Group, the world’s leading Italian pharmaceutical group, selected Sparta’s TrackWise Enterprise Quality Management System (EQMS) in May 2009. It wanted to simplify quality processes throughout its distributed manufacturing sites, replacing a previously time-consuming, paper-based and spreadsheet model to better track and manage all its corporate quality assurance processes.

Sparta Systems’ TrackWise software successfully managed a multitude of QA processes, including deviations, change control, complaint handling and audits. By deploying TrackWise, the company harmonised the quality procedures between its sites, reducing the time spent validating efforts, and improved the availability of critical information for its organisation-wide compliance.

The key to compliance is ‘say what you do and do what you say’; in other words, be in control. TrackWise provides a single gateway for the entry of quality processes. It will ensure the proper handling and routing of these events throughout the organisation in a compliant manner with the requirements of manufacturers and regulatory bodies. A key component of the system is the TrackWise Coordinator, a state-of-theart, 24/7 business rule engine, which implements automated escalations, alerts, routing, trending, distribution of reports and much more. TrackWise ensures compliance 100% of the time in different quality and compliance processes, for example, the handling of complaints and their ‘reportability’ to the agencies is done automatically – following a process of assignment, routing to regulatory departments and continuous monitoring to ensure compliance with corporate SOPs.

What do you believe makes Sparta better than the competition?
In one word, experience. TrackWise has been developed using constant feedback from our customers, EMEA and FDA since 1994. Today, TrackWise is being used by more than 250 life science companies, which over the past 15 years have contributed features to the software. According to a recent study, TrackWise is being used by 72% of the life science market.

The software is fully configurable and can be scalable to the needs of the customer. Once the customer purchases TrackWise, they can add more and more processes via configuration in a phase approach and the configuration can be done internally by the customer.

What backup and followup consultancy do you provide?
Sparta provides a complete solution. TrackWise is only one critical part of its solution offering. Sparta provides turnkey solutions, providing project management, configuration and implementation support, validation reports design and training for administrators and end-users. The global Sparta community continuously interacts online, via regional seminars, the TrackWise User Group and an annual user conference in the US and Europe.

How do you add value in terms of regulation and compliance?
There are two schools of thought for implementing TrackWise: (a) compliance to regulations; and (b) achieving control. Sparta adds value to pharmaceutical organisations by eliminating regulatory risk.

Sparta and TrackWise are known entities to the regulatory bodies. By being in control, our clients are streamlining operations via the TrackWise collaborative platform, reducing costs (IT and maintenance) and increasing profitability.

Company profile

Sparta Systems, Inc is a leading provider of enterprise quality management software. In addition to its US operations, the company provides sales and services to Europe, Asia and Australia through its subsidiaries Sparta Systems Europe Ltd and Sparta Systems Asia Pacific Ltd.

For more information, visit: www.sparta-systems.com.