Orthovita Taps MasterControl to Boost Part 11 Compliance Program
Orthovita, a biomaterials company specializing in the development of products that help restore fractured bones, just selected Master- Control's integrated quality management suite to facilitate compliance with 21 CFR Part 11 and other FDA requirements.
"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," said Michael Leonard, Orthovita's vice president of quality assurance (QA). "MasterControl is scalable as our company continues to grow and it provides a complete solution that meets the requirements of 21 CFR Part 11."
Flexibility With Control
Orthovita, which is also covered by 21 CFR Part 820 for medical devices, 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.
Part 11 requires validation of any electronic record-keeping system. Orthovita will be using MasterControl's comprehensive, full-cycle validation services, including installation qualification, operation qualification and performance qualification validation tests to make sure its system is Part 11 compliant.
Fresh from winning the client, MasterControl's Director of Marketing Jason Clegg shared his best advice for how an FDA-regulated life sciences company should vet any Part 11 vendor it is considering. When looking for a compliance solution, life science firms expect vendors to meet the following requirements:
Proven Experience -- Have successfully implemented solutions in their particular industry and environment for a number of years. Customer references and case studies should be readily available.
Audit Readiness -- The vendor should be willing to allow the firm to perform a vendor audit internally or through a reputable third party auditor.
Integrated Solutions -- Vendors need to have a product strategy that integrates key compliance and quality processes under a single web platform. These include, Corrective and Preventive Actions (CAPA), document change control, training/standard operating procedures enforcement, audits, customer complaints and any process specified in the FDA's good manufacturing practices. Such processes must be connected so that one triggers the next, until the entire loop is closed. This can be explained by the initiation of a customer complaint, deviation or out-of-specification result that would trigger the start of a CAPA process that if deemed necessary, would automatically initiate document control, change management and training control subsystems. These automatic triggers help life science firms ensure that problems don't fall through the cracks, as the completion of one subsystem automatically launches the next subsystem until the CAPA loop is closed.
Sustained Compliance -- Vendors should have a product development strategy to ensure that a system can be validated in a timely fashion. The cost to validate a system in an FDA environment typically costs just as much, if not more, than the actual software purchase price. Upgrading to a new release every year is usually not an option for life science firms unless one of the following two drivers is addressed:
The new version provides benefits that are so undeniable that the firm is compelled to upgrade. The vendor develops the product architecture and the validations tools in a way that validation is performed easier, more reliably, and in a cost-effective manner. -- Michael Causey