HOLMDEL, N.J., Jan. 23 /PRNewswire/ -- Sparta Systems, Inc., (Sparta), the maker of TrackWise(R), and the market leader in enterprise quality and compliance process management software, today announced that B. Braun Medical AG, Switzerland, a subsidiary of B. Braun Group, one of the world’s leading suppliers of healthcare products, has selected TrackWise as its 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 of Europe and the United States (FDA’s 21 CFR Part 11). TrackWise helps organizations increase efficiency and achieve compliance by automating workflow and facilitating trending and reporting.
B. Braun Medical AG will implement TrackWise to integrate and manage internal quality and environmental health and safety (EH&S) processes, including deviations, batch usage decisions, investigations, events, corrective and preventive actions (CAPA), change control, action items, effectiveness checks, internal audits and observations, and supplier audits and observations. The TrackWise system will be utilized by B. Braun Medical AG’s headquarters location and its four other manufacturing, service, and warehouse locations in Switzerland.
B. Braun Medical AG selected TrackWise based on its extensive benefits: a configurable architecture (to reduce validation and revalidation effort), the ability to eliminate manual processes and increase system utilization, the ease of integration with other quality applications, and the powerful analysis and trending capabilities.
“In addition to the impressive functionality, it was also important to see that TrackWise is widely used in the pharmaceutical, biotechnology, and medical device industries, and that Sparta understands the requirements that these manufacturers have to fulfil,” explained Dr Christian Audergon, Head of Quality, Safety, and Environmental Management, B. Braun Medical AG, Switzerland.
“TrackWise will streamline B. Braun Medical AG’s productivity by providing a web-based enterprise system that consolidates quality information and eliminates manual processes,” explained Tali Weinberg, Account Executive & Territory Manager, Sparta Systems Europe, Ltd. “The combination of increased collaboration, real-time reporting, and integration of electronic workflow processes, such as Deviations and CAPA, creates a dynamic quality management system that will reduce cycle time and effort, and provide secure, compliant data for real-time trending and reporting.”
“The TrackWise implementation by all sites of B. Braun Medical AG, Switzerland answers to not only a integrated strategy of compliance improvement in order to enter to new markets but also to strong expectations to increase the efficiency of our internal quality and EH&S management processes,” added Dr. Audergon. “We shall gain transparency and communication speed while we decrease our administrative workload to focus more on added- value activities. This shall bring benefits in terms of product quality, personal safety, environmental protection, and cost reduction.”
Sparta Systems’ subsidiary, Sparta Systems Europe, Ltd., will work collaboratively with B. Braun Medical AG, Switzerland throughout the TrackWise planning, implementation, and deployment phases.
About B. Braun Medical AG, Switzerland
B. Braun Medical AG, Switzerland, a subsidiary of the B. Braun Group, has five locations and over 750 employees throughout Switzerland, with its corporate headquarters located in Melsungen, Germany. B. Braun Medical AG is responsible for the production of disinfection and hygienic products, infusion accessories, solutions and volume replacement, and the reprocessing of sterile supplies. More information can be found at http://www.bbraun.ch or http://www.bbraun.com.
About B. Braun
B. Braun is one of the world’s leading suppliers of healthcare products with almost 31,000 employees in more than 50 countries around the world. The company’s four divisions orient their products and services toward different medical fields: hospital, surgery, private practice (medical care and doctors’ offices), and extracorporeal blood treatment. By networking divisional knowledge and developing solutions for the healthcare system, B. Braun transforms products and services into integrated systems. More information can be found at http://www.bbraun.com.
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.
Media Contact: Tracy R. Orlick Phone: (732) 203-0400 x119 Email: tracy.orlick@sparta-systems.com
Sparta Systems, Inc.
CONTACT: Media Contact: Tracy R. Orlick, Sparta Systems, Inc.,+1-732-203-0400 x119, Email: tracy.orlick@sparta-systems.com
