Leading Canadian Blood Processing Facility Relies On Tour Andover Controls to Ensure Safe and Sufficient Blood Supplies

Dec. 21, 2004
DALLAS – December 21, 2004 – Hema-Quebec, a leading Canadian blood processor, has installed new facility management systems at its headquarters, laboratories, and donor centers in Montreal and Quebec City to ensure facility-wide accountability and traceability of the environmental conditions in the labs and donor centers. Hema-Quebec selected the Continuum(R) Facility Management System with CFR Compliance Pack(TM) from Tour Andover Controls, a world leader in building automation, security systems and energy solutions. The Tour Andover system, installed by ACS Montreal, plays a critical role in verifying that Hema-Quebec complies with both Canadian and United States regulations regarding the collection, screening, preparation, and delivery of blood components. The CFR Compliance Pack is an optional enhancement to the Continuum system that allows Hema-Quebec to generate electronic records of environmental conditions at each facility 24 hours a day.Created in 1998 as part of the reorganization of Canada’s blood management system, Hema-Quebec collected more than 256,000 units of blood and provided blood products for more than 80,000 hospital patients in 2003. The Continuum Facility Management system plays a comprehensive role in the proper handling of blood at all Hema-Quebec locations through monitoring and controlling the heating, ventilation and air conditioning (HVAC) of their labs, cold rooms, donor centers, and offices. The system enables Hema-Quebec to comply with requirements to collect extensive data regarding the environmental parameters at the blood collection and processing facilities with integrated supervisory control and data acquisition (SCADA) capabilities and fault alarms for critical lab equipment and room temperature monitoring. Because the Continuum system can integrate SCADA capabilities with control and monitoring, Hema-Quebec was able to eliminate the need for a separate stand-alone data acquisition system.“We were impressed not only by the amount of valuable experience ACS Montréal has in laboratory environmental controls,” comments Luc Pelletier, Hema-Quebec’s facility director, “but also that Continuum could provide us with a single integrated system for HVAC control, cold room control and monitoring, and data acquisition.”Continuum’s CFR Compliance Pack was developed by Tour Andover Controls to help regulated businesses meet the Food and Drug Administration’s (FDA) 21 CRF Part 11 requirements which outline the electronic record and signature standards required to provide proof of overall regulatory compliance. These records include operational and environmental conditions that affect product safety, efficacy, and quality along with the details of the confirmed operator identity and explanation of actions taken. The CFR Compliance Pack software provides Hema-Quebec with tracking, record keeping, archiving, and report generation capabilities, along with rigorous password management and operator prompting features for all system changes and alarm acknowledgments. In addition, trend logs, operator and alarm activity reports, and access events can be generated automatically from these electronic records and formatted as secure, read-only Adobe PDF files. After verifying a report’s information, a department supervisor at Hema-Quebec can sign off on it by applying their digital signature to the document.“With Tour Andover’s CFR Compliance Pack, chart recorders, stored reams of paper records, microfiche film archives, and other physical manifestations of a now outdated paper-based legacy, are obsolete,” says Clive Smith, Tour Andover Controls’ life sciences industry marketing manager. “The Compliance Pack’s feature set allows Hema-Quebec to meet the FDA’s 21 CFR Part 11 electronic records and signature standards and derive all the advantages of electronic record keeping.”

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