Brian Wong, Pharm.D. and Director of QuadraCare, was looking for an alternative to a wireless temperature monitoring system, made by a well-known data logger vendor, which had serious reliability issues that led to costly and troublesome maintenance and unsupportive of QuadraCare’s regulatory requirements. Brian searched online with the expectation that the replacement wireless temperature monitoring system should be affordable, dependable, quick to install, easy to use, met FDA 21 CFR Part 11 requirements and would aid in QuadraCare’s regulatory audits.
Brian chose DeltaTRAK’s FlashLink Wireless System. After investigating several other wireless monitoring products that failed to meet the selection criteria, Brian worked with DeltaTRAK to determine the best solution for meeting QuadraCare’s regulatory, technical and financial requirements. QuadraCare bought the FlashLink Wireless System in January 2006 to record temperature in medication refrigerators, clean room and a temperature-controlled warehouse. The FlashLink Wireless System installed by Brian included one 900 MHz receiver with PC interface unit and server software, one repeater and four wireless temperature sensors.
"Helping QuadraCare pass regulatory audits, especially JCAHO, is the primary objective for us to acquire and use the DeltaTRAK FlashLink Wireless System. Secondary concerns were cost and the simplification of temperature monitoring…DeltaTRAK offered me the option of a trial system before use and helped me work out any operational issue prior to purchase…The FlashLink Wireless System helped us pass the JCAHO inspection with flying colors..."
Since installation, the 21 CFR Part 11 compliant FlashLink Wireless System has performed, 24 x 7, to Brian’s environmental monitoring specifications. QuadraCare is planning to build a second production area and expand the use of the FlashLink Wireless System to this facility. The FlashLink 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 accessible from any offsite location.
Established in 1989, DeltaTRAK, Inc. is a California-based leading manufacturer and marketer of cold chain management solutions and portable environmental test instruments used in healthcare, food and other major industries.
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Example of a temperature-sensitive infusion therapy ingredient used by QuadraCare
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FlashLink wireless sensor monitors temperature in QuadraCare’s clean room
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