B. Braun Medical AG, a supplier of health care products based in Switzerland, recently chose Sparta Systems TrackWise as its compliance and quality management system. TrackWise—Web-based tracking software for electronic tracking and trending, and the enterprisewide management of regulatory, organizational and quality compliance processes—meets European and U.S. electronic signature and record requirements, such as the Food and Drug Administration’s 21 CFR Part 11.

“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 fulfill,” explains Dr. Christian Audergon, head of quality, safety and environmental management for B. Braun Medical AG.

The company will implement TrackWise to manage and integrate internal quality and environmental safety and health processes, including investigations, deviation events, change control, batch usage decisions, action items, internal audits and observations, corrective and preventive actions, supplier audits, and observations and effectiveness checks.

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