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HemaCare Selects MasterControl™ Suite to Optimize Quality Management, Ensure FDA Compliance
SALT LAKE CITY March 1, 2006 MasterControl Inc. today announced that HemaCare Corp., a provider of blood products and services to 160 hospitals in southern California and the East Coast, recently selected the MasterControl™ quality management suite to optimize its quality processes and help ensure FDA compliance.
HemaCare and its subsidiary, Coral Blood Services, provide customized delivery of blood products, including collection and distribution of blood platelets and mobile whole blood collection operations. HemaCare, based in Woodland Hills, California, also provides therapeutic apheresis services to patients, both within a hospital and physician office environment.
"We manage a very extensive list of SOPs, forms, and other documents for our blood bank operations. With MasterControl, we will have greater control over these documents and the process itself," said Bob Chilton, HemaCare's executive vice president and chief financial officer. The organization also expects to promote efficiency and enhance its quality system with the help of MasterControl technology, he added.
HemaCare considered five other software solutions before making its decision. "MasterControl has the functionality that satisfies our needs at a favorable price," said Chilton. "Based on our interaction with the MasterControl staff, and based on the system's capabilities, we decided this is the right choice for us."
HemaCare, which is covered by the FDA's 21 CFR Parts 11, 210-211, and 606, will be automating its paper-based quality management system using a fully integrated MasterControl suite, consisting of MasterControl Documents™, MasterControl Forms™, and MasterControl Training™. HemaCare is accredited by the AABB (American Association of Blood Banks), an international association that promotes the highest standards for blood establishments.
FDA-regulated companies that choose to maintain electronic records to meet predicate rules are required under 21 CFR Part 11 to validate their electronic record-keeping systems. MasterControl will provide HemaCare with detailed, pre-written validation test protocols and scripts to help validate its system.