News | June 1, 2010

TrackWise® Electronic Regulatory Reporting Solution Enables Companies To Meet Current And Future Mandates

Source: Sparta Systems, Inc.

Sparta Systems Solution Simplifies Compliance and Reduces Quality-Related Risk for Organizations in Regulated Industries

Holmdel, NJ – Sparta Systems, Inc., the maker of TrackWise® software and the market leader in enterprise quality and compliance management solutions, is pleased to announce new additions to the TrackWise Electronic Regulatory Reporting (eReporting) solution to support ClinicalTrials.gov reporting and Medical Device Vigilance reporting. The addition of ClinicalTrials.gov reporting enables companies conducting clinical trials to streamline protocol registration and trial results reporting in accordance with FDA requirements. The solution also supports Medical Device Vigilance reporting to European health authorities that will become a mandate in the first quarter of 2010 for the German BfArM, (Federal Institute for Drugs and Medical Devices) with other European agencies to follow suit.

The TrackWise eReporting solution provides a single platform to meet the increasing electronic regulatory reporting needs of global health authorities. Through a flexible and intuitive mapping interface, data fields are linked to reporting data elements, eliminating the need for complex, lengthy and often costly customizations to ensure compliance with new or changing regulations. The eReporting solution in TrackWise offers a scalable platform well suited for the increase in electronic reporting obligations that organizations in highly regulated industries are facing today.

With more aggressive regulatory oversight arising across many industries, companies are now required to implement systems for ensuring quality, mitigating risk and maintaining regulatory compliance while protecting their business, consumers and the industry at large. Sparta Systems customers can use TrackWise software for electronic reporting to maintain compliance with key regulations, including

  • Electronic medical device reporting (eMDR) to the FDA
  • Electronic Medical Device Vigilance reporting to BfArM, France, UK and Ireland
  • Electronic clinical trials registration at ClinicalTrials.gov
  • Individual case safety reporting via E2B to health authorities worldwide

"With electronic reporting established as a strategic product imperative, Sparta has made the investment in a standards-agnostic electronic reporting platform fully integrated into the core product. This approach allows rapid support of both changing regulations and emerging standards, efficiently and without requiring code changes or customizations," said Mike Jovanis, vice president of product management, Sparta Systems. "Our eReporting solution helps ensure that those companies responsible for submitting reports do so in a timely and accurate manner, while integrating their reporting with a complete enterprise-wide quality management system to mitigate quality- and regulatory-related risk and achieving operational efficiencies."

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 14 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.

SOURCE: Sparta Systems, Inc.