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Community Blood Center of the Carolinas Selects MasterControl™ Quality Management Software Suite
SALT LAKE CITY May 15, 2006 MasterControl Inc. today announced that Community Blood Center of the Carolinas (CBCC), an independent, nonprofit organization, has selected the MasterControl™ quality management suite to facilitate FDA compliance and enhance efficiency.
CBCC supplies blood and blood products to 14 hospitals serving residents in 11 North Carolina counties and three South Carolina counties. The center, based in Charlotte, N.C., emphasizes regulatory compliance and quality assurance standards in its organizational mission.
CBCC was looking for a quality management solution with powerful document management, revision control, and training control features. The center needed a solution that will accurately capture the history of document revisions as well as employee training requirements and competency, said Beth Kinard, director of operations at CBCC. The center chose MasterControl over four other software providers.
Kinard said MasterControl's competitive edge included reasonable pricing, robust functionality, good reputation, and positive comments by other users. ?We also were able to do an onsite visit and see the program in action,? said Kinard, referring to CBCC's pre-selection audit of MasterControl's operations in its Salt Lake City headquarters.
Blood establishments are covered by the FDA's Current Good Manufacturing Practice (CGMP) regulations found in 21 CFR Parts 606 and 210-211. The center will be implementing a fully integrated MasterControl suite, consisting of:
CBCC expects to strengthen its compliance and accreditation efforts and foster efficiency with the help of MasterControl, said Kinard. The center is accredited by the American Association of Blood Banks (AABB), an international group that promotes the highest standards for blood establishments.
Under 21 CFR Part 11, FDA-regulated companies such as CBCC, which choose to maintain electronic records to meet predicate rules, are required to validate their electronic record-keeping systems. MasterControl will provide IQ and OQ protocols and a Validation Toolkit, which includes SOPs, templates, and risk assessment forms, to facilitate the center's validation efforts.
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