TrackWise keeps tabs on Polish pharma quality management

By Susan Gotensparre

- Last updated on GMT

Related tags: Management

Drug manufacturers have moved towards centralised data and
information management, following a trend to prevent human errors
and time-consuming tasks in response to increasing regulatory
requirements.

As an example of this trend, Polish pharmaceutical manufacturer Polpharma recently implemented TrackWise (from Sparta Systems) as its quality management and compliance system. Polpharma relies on the technology to improve quality processes, which should speed up decision-making, make trend analysis easier and prove cost-effective.

Data and information management is the challenge of current complex business environments, with Good Manufacturing Practice (GMP) requirements, ISO standards and industry best practices driving the industry away from manually managed and tracked processes. The laboratory information management systems (LIMS) market is forecast to increase from $307.4m (€237.5m) in 2005 to around $400m in 2010, according to a report by ARC Advisory Group.

"Continuous improvement in terms of quality and effectiveness is fundamental to the company's development and is considered as an important source of our competitive advantage,"​ Andrzej Szarmañski, Polpharma quality director, told In-PharmaTechnologist.com.

TrackWise is a web-based tracking software that centralises tracking and manages workflow and business processes without the need for separate servers. In addition, it meets electronic records and signatures requirements in both Europe and the US.

"Many companies waste unnecessary resources by searching for lost records, chasing down signatures and manually consolidating data for reporting. TrackWise automates these processes, reducing the effort required in addition to improving accuracy and ensuring compliance,​" said Steve Cagle, vice president of Sparta Systems. He added that TrackWise licenses have increased their sales in the 2005/06 fiscal year, by 40 per cent.

Polpharma intends to implement the system at two manufacturing sites in Starograd Gdanski, Poland, where TrackWise will manage the 'Change Control' and 'Corrective and Preventive Action' quality processes.

"These processes have a significant impact on our flexibility and time-to-market factors which are of paramount importance for generic manufacturers. After the first phase of the project we will be adding new processes and continue the roll out also to other sites,"​ concludes Szarmañski.

Polpharma specialises in gastrointestinal, cardiological and neurological drug production, operating primarily in Central and Eastern Europe.

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