Software offers FDA-compliant document management.

DeltaTRAK Dec 22, 2005

Press Release Summary:

Used in conjunction with In-Transit FlashLink Data Loggers plus Shadow Log(TM) Technology, FlashLink Data Manager allows users to manage documents electronically in compliance with FDA 21 CFR Part 11 guidelines. Program automatically tabulates and graphs data. Each record is then analyzed and given PASS or FAIL status based on degree-minute and other test criteria. All trip data is stored in secure database, allowing future queries and analytics.

Original Press Release:

DeltaTRAK Launches New FDA 21 CFR Part 11 Compliant Software

PLEASANTON, CA - DeltaTRAK, Inc., a leading manufacturer of cold chain monitoring solutions used by Life Sciences, Industrial and Food industries for over a decade, announces the new FDA 21 CFR Part 11 compliant In-Transit FlashLink Data Manager Software supporting all DeltaTRAK In-Transit FlashLink data logger models.

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(TM) 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.

FlashLink Data Manager 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. Beyond mere compliance, it has an innovative, built-in utility to corroborate organizational SOP (Standard Operating Procedures) in accordance with cGMP (Current Good Manufacturing Practices). The software provides data retrieval and analysis tools that are easy to use and visualize, saving critical-decision-making time. "The FDA 21 CFR Part 11 governs the modern electronic data management system used by the life sciences industry from data security and integrity standpoint," says Fred Wu, president of DeltaTRAK. "Providing data logging and management in a dependable manner is our specialty, and adding 21 CFR Part 11 to our software brings compliance to our Life Sciences customers. We are very excited to launch this innovative software solution that provides critical data and statistical analysis tools designed to simplify and expedite management decision-making process for quality control."

Since 1989, DeltaTRAK has been manufacturing the highest quality portable test instruments and software that monitor and record temperature, humidity, and pH parameters. Products and services are sold worldwide to customers in over 40 countries. Headquartered in Pleasanton, California, DeltaTRAK also has R & D offices in San Diego, California, a manufacturing and distribution facility in Modesto, California, as well as an electronic assembly operation in Shenzhen, China. DeltaTRAK can be reached by calling 1-800-962-6776, or by email to salesinfo@deltatrak.com. Detailed product information is available at www.deltatrak.com, or visit deltatrak.com/datamanager.shtml for additional information about FlashLink Data Manager Software.