Packaging Digest , 05/01/2003 40 5
Pharmaceutical validation package. (Product News).
COPYRIGHT 2003 Reed Business Information, Inc. (US)
The co.'s validation package includes information such as design and functional specifications, as well as standard operating procedures required to ensure consistent operation. Package also outlines product performance tests that can be conducted by customers to verify that design and performance meet the established specifications. This package of tests gives pharmaceutical customers a vendor-approved base from which to begin creating their internal testing procedures, saving them development costs and allowing them to create the FDA's required documentation. A tailored reliability engineering plan consisting of a preventive maintenance plan, an installation plan and an employee-training plan are also available. Current devices covered under the package include the SmartDate [R] family of thermal-transfer coders and the SmartLase [TM] laser coder. Markem Corp., 866/263-4644.
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