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PRESS RELEASE
Date: September 20, 2006
Release Date: Immediate
Contact: Wei Huang, Marketing Manager
(800) 962-6776, ext 4112 |
DELTATRAK MODESTO PLANT ISO REGISTERED
Pleasanton, California, September 20, 2006. – DeltaTRAK Inc.’s U.S. manufacturing plant and distribution center located in Modesto, California has been registered to ISO 9001:2000 (see Certification of Registration attached).
BSI Management Systems, the ISO authorized system evaluator and registrar, recently performed an on-site quality system audit and certified the Modesto plant’s operation to ISO 9001:2000. Compliance with ISO 9001 demonstrates a commitment to quality in all activities relating to the manufacturing, processing, warehousing and shipping of products at the Modesto plant. The Modesto facility is DeltaTRAK’s primary distribution site that supplies cold chain management solutions and portable environmental test instruments, such as thermometers, pH meters, remote wireless data acquisition and reporting systems, to distributors and end-user customers throughout North America, Asia, Europe, Latin America and the Middle East.
ISO 9000 is a set of international standards for a quality-oriented system. The focus on these standards is meeting customer expectations and requirements by increasing customer confidence in the supplier’s quality systems. The ISO 9000 standards provide specific guidelines for establishing, documenting, and maintaining an effective quality system to ensure that its products and services meet customer needs. Organizations that are ISO 9001:2000 certified have demonstrated an ability to consistently meet customer and applicable regulatory requirements and have enhanced customer satisfaction through processes for continuous improvement and the assurance of conformity to changing market needs.
"Having registered to ISO 9001 provides the DeltaTRAK Modesto plant a competitive advantage over other suppliers’ manufacturing facility allows DeltaTRAK to better serve the present and future needs of our customers," said Fred Wu, DeltaTRAK Inc.’s president. "Being ISO 9001 registered also positions DeltaTRAK to be able to compete for new business in the heavily regulated pharmaceutical and specialty material markets as the opportunities arise. Together with our already ISO 9001 registered Shenzhen, China assembly organization, the Modesto plant will continue to deliver superior values to our customers worldwide."
Since 1989, DeltaTRAK has been manufacturing the highest quality portable test instruments, supporting software and cold chain management solutions that monitor and record temperature, humidity, and pH parameters. DeltaTRAK products and services are sold worldwide to customers in over 40 countries. Headquartered in Pleasanton, California, DeltaTRAK also has a research and development center in San Diego, California, a manufacturing and distribution facility in Modesto, California and 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. |
Safeguards Precious Pharmaceuticals
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“DeltaTRAK FlashLink Wireless System helps us monitor and significantly minimize loss of expensive, environment-sensitive pharmaceuticals. The system’s reporting functions assist us in preparing for rigorous state and FDA audits and meeting pharmaceutical compounding and dispensing regulations.” - Art Whitney, president of Pacific West Pharmacy (PWP) and owner of Advantage Pharmaceutical Inc. (API) of Rocklin, California.
Founded in 1987 and late 2004 respectively, PWP and API service Long Term Care facilities and hospitals throughout California. PWP dispenses prescription drugs and API specializes in compounding custom medications unavailable commercially. FDA and US Pharmacopoeia 797 regulate and annually audit environmental controls in pharmacies and pharmaceutical compounding facilities / cleanrooms, hence why accurate and reliable environmental monitoring solution is critical. |
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| "We used to hand note data on sheets of paper everyday including weekends, now the process is automated... with alarm-notification..." | |
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Flash Link Wireless System monitors Advantage Pharmaceuticals’ compounding lab and PWP pharmacy’s temperature & humidity levels
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FlashLink Wireless Sensor monitors PWP pharmacy medication refrigerator temperature & humidity levels
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Troy Whitney, PWP/API Information Technology Manager, began searching for an economical, real-time, wireless solution after regulatory audits found the manual method has shortcomings in tracking temperature and humidity data.
PWP/API chose DeltaTRAK’s FlashLink Wireless System. After carefully evaluating several other wireless monitoring products that proved to be unsatisfactory, Troy worked with DeltaTRAK to determine the best solution for meeting his regulatory, technical and financial requirements. PWP/API purchased the FlashLink Wireless System in July 2005 to record temperature / humidity in medication refrigerators and clean rooms. The FlashLink Wireless System installed by Troy in two separate buildings includes one 900 MHz receiver with PC interface unit and server software, three repeaters and seven wireless temperature & humidity sensors.
"We used to hand note data on sheets of paper everyday including weekends,” says Troy, “now the process is automated and I get real-time information displayed on my computer with multiple alarm-notification options. In addition, the data management and reporting capabilities make record compilation for regulatory audits simple. The DeltaTRAK wireless system not only makes my job much easier it, also quickly justifies our investment by helping us efficiently monitor the environmental conditions of compounded medications worth from $100,000 to $200,000. This leads to improvement in our overall operating efficiency."
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Since installation, the 21 CFR Part 11 compliant FlashLink Wireless System has performed, 24 x 7, to PWP/API’s environmental monitoring specifications. PWP/API is looking to expand the system to monitor other environment-critical areas of their buildings. The wireless system manages up to 100 temperature and/or humidity sensors and, with the addition of the new Wireless SP Manager software, provides users with 24 x 7 information access from anywhere in the world.
Established in 1989, DeltaTRAK, Inc. is a California-based leading manufacturer and marketer of portable environmental testing and measurement systems used in healthcare, food and other major industries. | | |
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