The emPOWER Ankle is a complex active prosthetic foot and ankle solution that replaces muscle and tendon function, supporting users with additional energy while they walk. Because of the devices’ complexity, even slight changes to the product or documentation result in large amounts of paper documentation, which must be manually compiled and routed for review and approval. With a major re-design project on the horizon, BionX Medical Technologies Inc.’s engineers began evaluation solutions to replace the paper-based document control and change the control system that was becoming unmanageable.
Company officials wanted an electronic product lifecycle management (PLM) system that would efficiently manage a multi-level product structure/bill of material (BOM) and engineering change orders, with the ability to expand into other electronic records management such as training records, corrective and preventive actions (CAPA)/quality issues, and supplier management. The system had to meet the FDA 21 CFR Part 11 compliance requirements for electronic records and electronic signatures.
“We went through a discovery process during the course of several months, evaluating about five different solutions,” says Rick Smith, Sr. director, quality & regulatory, BionX Medical Technologies. “The system needed to be flexible, without being overly complex, with a fairly intuitive administrative interface. Pricing and ongoing licensing costs were also a factor, given our small size and limited resources. A matrix of requirements was created and the different solutions were ranked on how well they solved our particular needs, and Omnify Empower PLM was our choice.”
The software offers the ability to work solely with electronic documentation rather than maintaining paper records. BionX research and development (R&D) group gained the ability to approve changes electronically and remotely, along with the increased visibility into product design and development.
The company chose to implement Omnify Empower PLM in stages. They began with document control, change control, and validation of 21 CFR Part 11 compliance. Shortly after, they executed Training Management. Next, they managed supplier qualification documentation and linked their qualified suppliers to specific parts by implementing Supplier Management.
The company is in the process of adding Service Objects to maintain device history records, service records, and Quality/CAPA for non-conforming material.
“The Omnify Empower implementation has been extremely useful during business reviews with external parties. Information regarding testing, design, suppliers, marketing material, and training can be accessed in real-time, in a clear and presentable manner,” Smith says. “Several external reviewers have commented on how useful that has been; particularly helpful with our recent ISO 13485 re-certification.”
BionX Medical Technologies Inc.