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:
- MasterControl Documents™ ? This core application manages documents in a secure environment. It automates task assignment/routing, scheduling, follow-up, tracking, escalation, review, and approval for all documents-based processes. It provides a single Web-based repository for all documentation, making search and retrieval easy.
- MasterControl Forms™ ? Automates and manages all forms-based processes. It makes the transition from a paper-based system to an automated solution easy because it allows users to create electronic forms identical to their existing hard-copy forms. Companies can also design new forms to suit their needs.
- MasterControl Training™ ? Automates assignment, monitoring, and verification of training tasks, and grading of online exams. Training control can be integrated with the rest of the quality system, so any change to a document or process that warrants new training will automatically invoke training tasks upon approval of the change.
- MasterControl CAPA™ ? Provides best-practice electronic forms and workflow routes that can be used as is, or customized based on a company's needs, including the "8D" process to guide a team throughout CAPA implementation. It provides the capability to launch a CAPA form directly from another form (e.g., audit finding) for a more streamlined operation. It can be integrated with other processes, such as training control, so training tasks will be invoked as soon as a CAPA is approved.
- MasterControl Change Control™ ? Automates and streamlines the entire change control procedure for faster turnaround. It offers a best-practice form that incorporates priority level and prompts risk assessment and classification of the change as low, medium, or high.
- MasterControl Audit™ ? Automates, streamlines, and effectively manages the audit process. It provides advanced tracking capability, from scheduling and planning to execution and completion. It automates scheduling of all recurring audit-related activities.
- MasterControl Customer Complaints™ ? Streamlines the complaint-handling process and reduces the lifecycle from submission to resolution. A simple, three-step process is incorporated in a pre-configured, multi-page form that starts with the processing of a customer complaint, automatically moving to internal investigation, and culminating with resolution of the issue.
- MasterControl Nonconformance™ ? Automates, manages, and streamlines the process for identifying, evaluating, reviewing, and handling of nonconforming materials, components, parts, and finished products. It provides a pre-configured, multi-page form that simplifies and accelerates disposition of nonconforming materials.
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.
MasterControl Inc. has been at the forefront of providing innovative electronic quality management systems since 1993. MasterControl provides a configurable, easy-to-use, and integrated system to help companies effectively manage document control, change control, training control, audits, corrective/preventive action (CAPA), customer complaints, and other processes under a single Web-based platform. The company offers comprehensive technical and customer support, including product training, installation, implementation, and validation services. Hundreds of companies use MasterControl to meet stringent FDA requirements, but many others also use it for compliance with ISO standards, Sarbanes-Oxley Act, and other regulations. For more information, visit www.mastercontrol.com, or call 800-825-9117.