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MasterControl Public Relations
BioMimetic Therapeutics, Innovator of Drug-Device Combination Orthopedic Therapies, Chooses MasterControl
SALT LAKE CITY Apr. 2, 2007 MasterControl Inc. today announced that BioMimetic Therapeutics Inc., a leader in drug-device combination orthopedic therapies, has chosen the MasterControl suite to facilitate compliance with FDA regulations and ISO 13485: 2003 standards.
BioMimetic Therapeutics, based in Franklin, Tenn., is developing biologically enhanced therapies to speed the healing of orthopedic, periodontal, craniofacial, and sports injuries. The company is uniquely positioned to develop a variety of enhanced therapies that combine synthetic and natural scaffold materials and a biologically active growth factor (rhPDGF-BB), designed to stimulate tissue regeneration and repair for faster healing and a better functional outcome for the patient.
BioMimetic's innovative products make it a unique company. The lead product and product candidates are being developed in the United States as medical device combination products, while in Europe they are being developed as medicinals. The FDA regulates BioMimetic Therapeutics' products through its medical device center. In the EU, the European Agency for the Evaluation of Medicinal Products regulates the rhPDGF-BB component, while the synthetic matrix is regulated separately as a medical device. In terms of regulatory compliance, the company complies with both FDA and European Union regulations. To maintain its ISO 13485 certification, the company also conforms to ISO quality standards for medical devices.
?We are a unique company with equally unique needs. We chose MasterControl because it met our business and complex regulatory compliance objectives,? said Tom Golden, manager of document control and learning services at BioMimetic Therapeutics. ?The company selected the MasterControl suite over seven other software solutions for a number of reasons: the software is easy to use; MasterControl has more than a decade of experience in regulated environments and is well-established; and MasterControl is attentive and responsive to its customers.?
By switching from a paper-based quality system to a Web-based MasterControl system, BioMimetic Therapeutics expects to achieve greater efficiency and traceability, as well as accessibility for senior staff members who need to travel and at the same time participate in quality processes.
BioMimetic Therapeutics will be implementing the MasterControl suite, consisting of the following:
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 BioMimetic Therapeutics with a comprehensive, full- cycle validation package that includes IQ, OQ, and PQ test protocols and onsite execution services.