Orthovita Inc. Selects MasterControl™ Quality Software Suite to Facilitate 21 CFR Part 11 Compliance
SALT LAKE CITY January 3, 2006 MasterControl Inc. today announced that Orthovita Inc., a biomaterials company specializing in the development of novel products that help restore fractured bones, has selected the MasterControl™ integrated quality management suite to facilitate compliance with 21 CFR Part 11 and other FDA requirements.
Orthovita, founded in 1992, is a biomaterials company with proprietary technologies for the development and commercialization of synthetic, biologically active, tissue engineering products for orthopedic and neurosurgical applications. Their products are used in the regeneration of bone and soft tissue. Their product offerings include the Vitoss® Bone Graft Substitute technology platform, which is designed to address the non-structural bone graft market by offering synthetic alternatives to the use of autograft or cadaver-derived bone material to meet a broad range of orthopedic clinical needs in the spine, trauma, joint reconstruction, revision surgery and extremities markets, and Vitagel? Surgical Hemostat, which is a safe adherent matrix and an impermeable barrier to blood flow. The Cortoss® Synthetic Cortical Bone technology platform, which is designed for injections in osteoporotic spines to treat vertebral compression fractures is sold in Europe and in clinical trials in the U.S.
?After researching other electronic document management systems on the market, we selected MasterControl because it is well-suited for fast-growing med-tech companies like Orthovita. MasterControl is scalable as our company continues to grow and it provides a complete solution that meets the requirements of 21 CFR Part 11,? said Michael Leonard, Orthovita's vice president of quality assurance.
Orthovita, which is also covered by 21 CFR Part 820, will be implementing a fully integrated MasterControl quality management system, consisting of MasterControl Documents™, MasterControl Forms™, and MasterControl Training™. Using MasterControl to automate Orthovita's paper-based document control system, the company expects to save on compliance costs and improve document cycle times, said Leonard. ?We expect MasterControl to significantly enhance our quality system and improve efficiency, ? he added.
The FDA's 21 CFR Part 11 requires validation of any electronic record-keeping system. Orthovita will be utilizing MasterControl's comprehensive, full-cycle validation services, including IQ (installation qualification), OQ (operation qualification), and PQ (performance qualification) validation tests to make sure its system is Part 11 compliant.