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Data Logger Software Is Now 21 CFR Part 11 Compliant

The FlashLink Data Manager desktop application is a comprehensive data management tool for use in conjunction with the In-Transit FlashLink Data Loggers plus Shadow Log Technology. It automatically tabulates and graphs data downloaded from a FlashLink data logger. Each data logger record is then analyzed and given a “PASS” or “FAIL” status based on degree-minute and other test criteria, making shipment acceptance or rejection decision easy. All trip data are stored in a secure database, allowing future queries and analytics. The software is fully password protected with individual access rights to each key function. It offers complete activity audit trail, making record management easy and secure. Software allows users to manage documents electronically in compliance with FDA 21 CFR Part 11 guidelines. Key areas of the guidelines include authentication, access control, audit trail, data protection, signature manifestation, etc.




DeltaTRAK, Inc.
P.O. Box 398
Pleasanton, CA, 94566




 
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