Poland’s Leading Pharmaceutical Product Manufacturer Selects TrackWise Software as its Enterprise Quality Management System
HOLMDEL, N.J., Jan. 8 /PRNewswire/ — Sparta Systems, Inc., (Sparta), the maker of TrackWise(R), and the market leader in enterprise quality and compliance management software, today announced that Polpharma SA, Poland’s leading manufacturer of drug products and active pharmaceutical ingredients, has begun implementation of TrackWise as its enterprise quality management and compliance system.
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. It meets electronic record and signature requirements in the United States (21 CFR Part 11) and Europe. TrackWise helps organizations increase efficiency and achieve compliance by automating workflow and facilitating trending and reporting.
Polpharma’s goal of running lean quality operations and its dedication to continuous improvement led its quality assurance team to evaluate electronic systems that would replace decentralized, paper-based processes.
“Polpharma SA selected Sparta Systems’ TrackWise software because it offers a complete and integrated solution for all quality processes,” explained Andrzej Szarmanski, Quality Director, Polpharma SA. “The system can be deployed in any language, is fully configurable to support our business needs, and has a proven track record in the life sciences industries.”
The TrackWise implementation is already underway at Polpharma’s manufacturing site in Starogard Gdanski, Poland. The system will initially be used to manage internal Change Control, Deviations, Investigation, and Corrective and Preventive Actions. Later this year, Polpharma plans to deploy TrackWise for additional processes, including Audits, Observations, Document Management, and Customer Complaints.
“TrackWise will enable Polpharma SA to increase efficiency and improve decision making by capturing all quality related data in a centralized system,” said Tali Weinberg, Territory & Account Executive at Sparta Systems Europe, Ltd. “The system will allow Polpharma SA to proactively analyze information, identify potential trends, and prevent potential quality problems.”
“TrackWise not only provides us with cutting-edge technology, but also provides us with a great opportunity to improve management of key quality processes,” commented Szarmanski. “TrackWise will enable Polpharma to reduce cycle time, increase procedural visibility, and instantaneously enforce quality control. The system is a universal driver to support continuous improvement by helping the company become even more competitive in today’s complex business environment.”
About Polpharma SA
Polpharma is the largest manufacturer of drug products and active pharmaceutical ingredients in Poland. Founded in 1935, Polpharma combines tradition and experience with modern technologies and the highest manufacturing standards. Polpharma specializes in the production of cardiological, gastrointestinal, and neurological drugs. It manufactures solid forms such as tablets, film coated and sugar coated tablets, capsules, effervescent tablets, and liquid drug formulations which include injectable preparations in polyethylene and glass ampoules, single and multi-dose eye drops, nasal drops and fluids for topical use. Polpharma’s products are present in nearly 50 countries worldwide, with its primary markets in Central and Eastern Europe, and a strong position in Europe and the United States in the area of fine chemicals. Polpharma has representative offices in Russia, Lithuania, Ukraine and Kazakhstan. More information can be found at http://www.polpharma.pl.
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 12 years of experience and an extensive customer base in the life sciences and other highly regulated industries. Sparta Systems offers its customers a complete solution for global quality management needs, including the onsite support required throughout the project lifecycle. More information about Sparta Systems and TrackWise can be found at http://www.sparta-systems.com.
