Software manages production records for compliance.
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Press Release Summary:
Celltrack PRO(TM) enterprise software is designed for medical device manufacturers that need to comply with FDA's 21 CFR Part 11 regulation. It records, maintains, archives, retrieves, and transmits relevant manufacturing data, including batch detail and downstream processing, equipment settings, and measurements. Closed data chain, with high-level access control and record-validity checks, guarantees tamper-free data integrity from point of collection through reporting and archiving.
Original Press Release:
American MSI Announces Solution for 21 CFR Part 11 Compliance
Celltrack PRO(TM) provides production records management for compliance and product liability administration
MOORPARK, CA- Wednesday, October 2, 2002 - American MSI today announced Celltrack PRO(TM), an enterprise software application for medical device manufacturers that need to comply with the FDA's 21 CFR Part 11 regulation.
Celltrack PRO(TM) records, maintains, archives, retrieves, and transmits relevant manufacturing data. This includes batch detail and downstream processing, equipment settings and measurements, as well as who changed what, when, where and even why. A closed data chain with high-level access control and record validity checks guarantees tamper-free data integrity from the point of data collection through reporting and archiving.
"Unlike other solutions that are derivatives of resource planning or production monitoring applications, Celltrack PRO(TM) was designed entirely from the ground up to meet the stringent 21 CFR Part 11 requirements." says Tim Triplett, American MSI's President and CEO "American MSI provides an end-to-end solution that reduces the complexities involved with bringing operations into compliance".
"Celltrack PRO(TM) has tremendous appeal beyond 21 CFR Part 11 compliance" added Serge Jonnaert, Executive Vice President, Marketing. "Every year, thousands of products are recalled either voluntarily or by order of consumer protection agencies such as the Food and Drug Administration (FDA), the National Highway Traffic Safety Administration (NHTSA), or the Consumer Product Safety Commission (CPSC). Celltrack PRO(TM) can reduce a company's financial exposure by limiting recalls to production batches with specific fail criteria, and will contribute to improved product quality through increased visibility of production and employee activities."
Celltrack PRO(TM) is the latest addition to American MSI's Industrial IT portfolio of products which also includes iNet(TM), a three tier industrial networking solution, vNet(TM), an Internet based video production monitoring system, and a broad array of protocol converters to bring plastics conversion equipment into a networked environment.
Celltrack PRO(TM) will be available early Q1 2003. American MSI has several Celltrack PRO(TM) pilots under way with large pharmaceutical companies.
About American MSI Corporation
American MSI Corporation is a global provider of control, data acquisition and plant floor connectivity solutions for the injection molding industry. Since 1984, American MSI Corporation has focused on delivering advanced technologies that install rapidly and immediately deliver tangible results, even in the most stringent environments. American MSI Corporation serves the world's leading suppliers, including Abbott Laboratories, Becton-Dickinson, Gillette, Baxter Healthcare, SC Johnson Wax, 3M, Chrysler, Delphi, Colgate-Palmolive, Eastman Kodak, Schick, Nypro, TRW, Bose, Ciba Vision, Johnson & Johnson, Vistakon, Terumo Medical, Volkswagen, Mattel, Whirlpool, Nissan, and countless others.
CONTACT: Serge Jonnaert
(805) 523-9593 Ext. 111
serge_jonnaert@americanmsi.com
