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News

Ratiopharm selects TrackWise software as enterprise tools

Sparta Systems : 04 June, 2007  (New Product)
Ratiopharm has selected Sparta Systems' TrackWise as its enterprise tool for managing deviations, corrective and preventive actions (CAPA) and audits.
TrackWise is a web based tracking software tool for electronically managing, tracking, and trending quality, regulatory, and organizational compliance processes and action items across the enterprise.

TrackWise increases efficiency and ensures compliance by integrating data and processes into a centralised system, automating workflow, facilitating trending and reporting, and executing business rules.

Ratiopharm's global growth and quality initiatives led the company to evaluate enterprise quality management software systems to replace siloed databases and paper-based forms.

The company envisioned a powerful system that would eliminate errors, speed cycle time, increase record transparency, and reduce associated operational costs.

TrackWise was selected based on its features, flexibility, rapid implementation time, and Sparta Systems' recognised best practices in the life sciences industry.

ratiopharm will phase out its databases and manual processes and automate them with TrackWise.

The TrackWise system will streamline the company's deviations, CAPA, and audit management processes with an automated workflow engine, patented business rules engine, built-in workflow tools, integrated reporting and trending, and automated escalation features.
The initial implementation will encompass the ratiopharm production sites, and is slated for 2007 completion, with systematic expansion planned for other groups.

'Managing multiple quality related processes with disjointed office applications limits you in terms of data availability, data safety, accurate trending, and transparency of information', explained Britta Rotte, QA manager, ratiopharm.

'TrackWise will facilitate the needs of our corporate QA system by centralising QA processes and providing the data needed for tracking and trending quality issues to support improvement initiatives'.

'Furthermore, the extensive configurability of TrackWise will allow us to create detailed processes without touching the source code of the system, reducing validation and revalidation effort'.

'Selecting an electronic quality and compliance management system that is easily adaptable to business and regulatory change is critical for life science companies', explained Yaniv Vardi, vice president, operations, Sparta Systems Europe.

'TrackWise's ability to manage unlimited workflows on a centralised, vendor neutral platform will enable ratiopharm to meet its current and future compliance needs seamlessly without changes to code or the installation of additional modules, which will provide a significant return on investment'.

Subsequent planning for further QA processes at ratiopharm includes change control, validation, qualification, and SOP management.
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