Press Release
IQ/OQ Protocol for In-Transit FlashLink® Data Manager Software
Pleasanton, California, April 7, 2006 — DeltaTRAK, Inc., a Pleasanton, California-based leading manufacturer and marketer of cold chain management systems and test instruments, is announcing the availability of IQ/OQ (Installation Qualification / Operational Qualification) Protocol for the In-Transit FlashLink Data Manager Software, a proven tool for the world of in-transit environmental data validation and reporting developed by DeltaTRAK. The In-Transit FlashLink Data Manager Software, with the IQ/OQ Protocol, greatly enhances the overall manageability and reporting capability of data gathered by the DeltaTRAK In-Transit FlashLink Data Loggers. This enables users to better meet data integrity and security requirements defined by FDA 21 CFR Part 11 and in support of their cGMP (current Good Manufacturing Practice). Trip data and reports can now be compiled, analyzed, validated and presented in much simplified and guided ways not previously possible.
The In-Transit FlashLink series software and hardware provide a significant cost savings to users who require convenient and cost effective “fail-safe” trip data collection and recording.
“Customers with the new DeltaTRAK IQ/OQ Protocol will appreciate the step-by-step guide to software validation and data management offered by the Data Manager Software because it eliminates the time consuming process of developing your own software validation protocol from scratch. With the DeltaTRAK IQ/OQ Protocol, the Data Manager Software is assured with robust data categorization, validation and reporting in compliance with 21 CFR Part 11 and cGMP requirements,” said Fred Wu, President of DeltaTRAK, inc.
The IQ/OQ Protocol comes complete with software setup instructions, data validation verifications and references. The IQ/OQ Protocol, which comes in hardcopy form and on a CD ROM, is packaged in a dark blue business 3-ring binder cased in a durable presentation box.
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, 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.
The In-Transit FlashLink series software and hardware provide a significant cost savings to users who require convenient and cost effective “fail-safe” trip data collection and recording.
“Customers with the new DeltaTRAK IQ/OQ Protocol will appreciate the step-by-step guide to software validation and data management offered by the Data Manager Software because it eliminates the time consuming process of developing your own software validation protocol from scratch. With the DeltaTRAK IQ/OQ Protocol, the Data Manager Software is assured with robust data categorization, validation and reporting in compliance with 21 CFR Part 11 and cGMP requirements,” said Fred Wu, President of DeltaTRAK, inc.
The IQ/OQ Protocol comes complete with software setup instructions, data validation verifications and references. The IQ/OQ Protocol, which comes in hardcopy form and on a CD ROM, is packaged in a dark blue business 3-ring binder cased in a durable presentation box.
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, 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.