PLIVA-Lachema Selects Sparta GCP Software to Manage Trials

PLIVA-Lachema, the Czech affiliate of multinational specialty pharmaceutical manufacturer PLIVA, has chosen Sparta Systems’ TrackWise software to electronically manage its quality and regulatory processes.

This software was first introduced in 1998 and is intended for good clinical practice (GCP) needs, Yaniv Vardi, director of operations for Sparta Systems Europe, told PIR. “In a clinical trial, you need to track deviations from expectations. Out of these deviations you generate investigations and corrective or preventive actions, and do trending and statistical analysis,” he explained.

PLIVA-Lachema’s adoption of the software package marked a transition from a system that mixed paper records and disparate programs, said Sahaf Flam, managing director of Sparta Systems Europe. “In most of the cases, they are going from paper or an internal system based on Microsoft Word or Excel to electronic quality management,” he explained.

PLIVA had been relying on a hybrid system of paper records and Microsoft Excel and Microsoft Access-based “small applications” to keep track of regulatory events before it adopted TrackWise, said Marijo Volarevic, a member of PLIVA’s global IT organization. “The biggest implementation so far is in Brno [Czech Republic], which didn’t have much IT infrastructure,” he said. “When we prepared for the U.S. market, we needed a centralized infrastructure. TrackWise is quality-focused, and people liked it and adopted it very quickly.”

PLIVA also uses the system for complaints and audits in its East Hanover, N.J. facility, and the firm’s Krakow, Poland facility will adopt the system for close integration with Brno’s, he said. The software’s multilingual capability is critical in a company with facilities in the Czech Republic, Poland, Croatia, the U.S. and elsewhere. PLIVA users of TrackWise also liked the fact that the system is “quite light,” without a long history of multiple versions. This eases implementation, said Volarevic.

Integrating the quality control needs of various employees is a strength of TrackWise, Vardi explained. “Each corrective and preventive action is a separate process, with a separate person responsible,” said Vardi, adding that “all these clinical actions are related to GCP in one database.” Researchers and management can access the database to generate reports.

User-Configurable Software

Another distinguishing feature of TrackWise, according to Vardi, is “the ability to configure it without the need for developers to change the source code. The user can configure the business rules engine to set the due date or other field based on SOPs [standard operating procedures], with alerts generated automatically based on your SOPs.” Weekly reports can be generated, along with alerts when a certain number of deviations are exceeded, he said.

Quality control was the most important factor in PLIVA’s decision to adopt TrackWise, even outweighing the regulatory and financial aspects, Volarevic said. Nevertheless, “compliance is the driver of the whole story, conforming our procedures to what the regulatory agencies require.”

Good manufacturing practices (GMPs) are increasingly standardized, he noted. FDA requirements and those of the European Medicines Agency (EMEA) are “basically the same,” although their auditing procedures may differ, he noted.

The U.S. is PLIVA’s fastest-growing market, but the firm also does substantial business in Central and Eastern Europe, as well as in Russia. Vardi said TrackWise is compliant with FDA and EMEA regulations, as well as those of Japan and Canada.