As a small developer and manufacturer of a complex robotic prosthetic device, maintaining a paper-based document control and change control system was becoming unmanageable. The complexity of the device meant that even a small change to the product or documentation resulted in a large paper documentation package which had to be manually compiled and routed for review and approval.
With a major re-design project on the immediate horizon, it was essential to identify and implement a more efficient document control solution ahead of the large volume of new product design documentation that was expected. BionX wanted an electronic system that would be able to 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, CAPA/Quality issues and supplier management. The system also had to meet the FDA 21 CFR Part 11 compliance requirements for electronic records and electronic signatures.
"We went through a discovery process over the course of several months, evaluating about five different solutions," stated Rick Smith, Sr. Director, Quality & Regulatory for BionX Medical Technologies. "A matrix of requirements was created and the different solutions were ranked as to how well they solved our particular needs and Omnify Empower PLM was our top choice."
We use cookies to help provide you with the best possible online experience.
By using this site, you agree that we may store and access cookies on your device.
You can find out more and set your own preferences here.
