PLIVA – Lachema Implements Sparta Systems’ TrackWise® Software for Nine Quality Applications
Sparta Systems, Inc., (Sparta), the market leader in enterprise quality and compliance management software for the life sciences and other highly regulated industries, announced today that PLIVA – Lachema a.s. Czech Republic, an affiliate of global specialty pharmaceutical manufacturer PLIVA, has gone live with Sparta’s TrackWise software. The TrackWise system is enabling PLIVA – Lachema to electronically manage quality and regulatory processes. TrackWise is currently deployed at PLIVA’s corporate Brno center of excellence for Oncology products in the Czech Republic, PLIVA – Lachema. The implementation itself, from planning to production, took less than four months.
TrackWise is an off-the-shelf, fully configurable, enterprise web-based tracking software platform used to electronically log, manage, query, report and trend quality and regulatory incidents and action items. TrackWise helps organizations increase efficiencies and achieve compliance by linking and consolidating related events and actions, automating workflow, implementing business rules, and facilitating trending and reporting across quality systems and related work areas. The system also complies with Title 21 CFR Part 11, which governs electronic records and electronic signatures.
PLIVA – Lachema selected TrackWise to replace several disconnected quality management applications. With its implementation of TrackWise, PLIVA – Lachema has efficiently centralized its quality processes to ensure compliance and identify opportunities for quality improvement. PLIVA – Lachema now uses TrackWise for management of its Deviation, CAPA, Change Control, Complaints, Task Management, Investigation, Internal Audit, Internal Audit Observation, External Audit and External Audit Observation processes.
TrackWise’s embedded multi-language functionality allowed PLIVA to translate system terminology to Czech and Polish through use of Sparta’s patent-pending multi-language functionality. Following the successful TrackWise implementation in PLIVA –- Lachema, PLIVA is now developing its next phase of TrackWise deployments for PLIVA-Krakow, Poland, and is considering the possibility of utilizing TrackWise for integration of corporate quality processes.
“PLIVA – Lachema’s project team, including Project Manager Leopold Bartos and Project Administrator Dita Burianová were instrumental in the planning and rapid deployment of the TrackWise system,” said Sahaf Flam, Managing Director, Sparta Systems Europe, Ltd. “They were able to immediately take on the administration and support of the system once Sparta’s Product Specialist completed the standard on-site assistance program. This can be credited to the dedication of PLIVA’s management, as well to the user-friendliness of the TrackWise configuration tools.”
About PLIVA
With 85 years of experience in the pharmaceuticals arena, PLIVA is a global generics company with operations in more than 30 countries worldwide and the leading pharmaceutical company based in Central and Eastern Europe (CEE). PLIVA is widely recognized for its R&D excellence – and most notably for the discovery of its blockbuster, new generation antibiotic azithromycin. Building upon its proud R&D history, the company specializes in the development, production and distribution of generic pharmaceutical products and has been listed on the London Stock Exchange since 1996.
About PLIVA – Lachema
The history of PLIVA – Lachema dates from 1951 when the national enterprise Lachema began the manufacture, finishing and packing of laboratory and specialty chemicals. The company joined the PLIVA Group in 1999, and currently focuses on the research, development and production of generic pharmaceuticals – especially cytostatics and support therapy. In 2004 PLIVA – Lachema was classified by the FDA as suitable for the production of Active Pharmaceutical Ingredients and Sterile Dosage Forms for the American market.
About Sparta Systems
Sparta Systems, Inc. is the industry leader for global quality and compliance management systems. Its TrackWise product is a web-based software application used by quality, manufacturing, and regulatory affairs professionals to manage quality and compliance issues across the enterprise. The company has more than 11 years of vendor experience, with over 120 accounts in the highly regulated life science industries. Sparta Systems offers its customers a complete solution for global quality management needs, including the onsite support required throughout the project lifecycle. Information about Sparta Systems’ products and services can be found at www.sparta-systems.com .
