Navigation Links
TrackWise(R) Electronic Regulatory Reporting Solution Enables Companies to Meet Current and Future Mandates
Date:12/9/2009

HOLMDEL, N.J., Dec. 9 /PRNewswire/ -- 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."

For more information on TrackWise eReporting, please contact insidesales@spartasystems.com

About Sparta Systems

Sparta Systems, Inc., is an 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 15 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 www.spartasystems.com.

Sparta Systems and TrackWise are trademarks or registered trademarks of Sparta Systems, Inc. All other marks are trademarks of their respective companies.


PR Contacts:
Jon Rabinowitz
Director of Marketing
Sparta Systems, Inc.
Tel: 732.203.0400, ext. 121
jon.rabinowitz@sparta-systems.com

Kate Corcoran
Articulate Communications Inc.
Tel: 212.255.0080, ext. 18
kcorcoran@articulatepr.com

SOURCE Sparta Systems, Inc.


'/>"/>
SOURCE Sparta Systems, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Sparta Systems Unveils TrackWise(R) Clinical Quality Management Solution
2. Leading Italian Pharmaceutical Group Deploys TrackWise(R) Solution to Improve Quality Processes
3. Global Therapeutics Manufacturer Selects TrackWise(R) to Reduce the Cost of Compliance
4. Sparta Systems Strengthens TrackWise(R) Enterprise Class Quality Management Solution with Robust Web Services Capabilities
5. Netherlands Vaccine Institute Chooses TrackWise(R) Solution for Enterprise-wide Compliance with Good Manufacturing Practices
6. Moses Cone Health System Selects Streamline Health to Enhance the Electronic Medical Record
7. Union Hospital, Hong Kong, Selects First DataBank's Electronic Drug Information in Medication Safety Initiative
8. Secure-24 and ATMP Consulting Group Launch Partnership for Private Practice Physicians to Meet IT and Electronic Medical Record Standards
9. A Smokeless Holiday Season? Premium Electronic Cigarette Announces New Disposable Smokeless Cigarette Product
10. Stop Smoking Cigarette with Electronic Cigarette (E-Cig), Today You Can Quit Smoking Too
11. U.S. Healthcare Efficiency Index(TM) Launches Primary Data Collection to Measure Current State of Electronic Adoption and Potential Cost Savings
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... Creek, Michigan (PRWEB) , ... June 26, 2016 , ... ... joined as sponsor of the 2016 Cereal Festival and World’s Longest Breakfast Table in ... in honor of the city’s history as home to some of the world’s leading ...
(Date:6/26/2016)... Carolina (PRWEB) , ... June 26, 2016 , ... ... of a new product that was developed to enhance the health of felines. The ... centuries. , The two main herbs in the PawPaws Cat Kidney Support ...
(Date:6/26/2016)... , ... June 26, 2016 , ... ... once they have been diagnosed with endometriosis. These women need a treatment plan ... require a comprehensive approach that can help for preservation of fertility and ultimately ...
(Date:6/25/2016)... TX (PRWEB) , ... June 25, 2016 , ... Austin ... of the American College of Mohs Surgery and to Dr. Russell Peckham for medical ... and highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX ... Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over ... Cut Pro X . Simply select a ProHand generator and drag it above media ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... OTTAWA, Ontario , June 27, 2016  VMS ... the Company,s Board will take whatever measures required to ... the Company,s stock which is currently listed on the ... S Wexler, Company Chairman and CEO, "We are seeing ... be difficult to understand, not only by the Company, ...
(Date:6/24/2016)... June 24, 2016  Collagen Matrix, Inc., ("Collagen ... and manufacturing of collagen and mineral based medical ... that Bill Messer has joined the ... further leverage the growing portfolio of oral surgery, ... Bill joins the Collagen Matrix executive team ...
(Date:6/24/2016)... DUBLIN , June 24, 2016 ... and Markets has announced the addition of the ... their offering. ... products and provides an updated review, including its applications ... covering the total market, which includes three main industries: ...
Breaking Medicine Technology: