Challenge: Paper-Based Document and Change Control System
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 redesign 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.
Goal: Transition to an Electronic System Suitable for Medical Devices Regulated by the FDA
BionX wanted to transition from its paper processes to an electronic system that would be able to efficiently manage a multi-level product structure/bill of material and engineering change orders with the ability to expand into other electronic records management such as training records, CAPA/quality issues, and supplier management. A key requirement was that the system met 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, senior director, quality & regulatory for 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.”
Smith added, “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.”
Solution: Time to Market, Compliance, and Efficiency
Adoption of Omnify Empower PLM was very well received at BionX Medical Technologies. The R&D group is very satisfied with the ability to work solely with electronic documentation rather than maintain paper records, and management has been pleased with the ability to approve changes electronically and remotely, along with the increased overall visibility into product design and development activities within the business.
The company chose to implement Empower in stages based on business needs, starting with document control, change control, and validation of 21 CFR Part 11 compliance. Shortly after, they executed Training Management, which enables employees to record training to procedures and easily see tasks assigned to them. The next stage was Supplier Management in order to manage Supplier Qualification documentation and link qualified suppliers to specific parts. Currently, the company is working on implementing Service Objects for maintaining device history records and service records, and quality/CAPA (corrective and preventive action) for non-conforming material.
“The Omnify Empower implementation has been extremely useful during business reviews with external parties in that information regarding testing, design, suppliers, marketing material, and training can be accessed in real-time in a clear and presentable manner,” stated Smith. “Several external reviewers have commented on how useful that has been and was particularly helpful with our recent ISO 13485 re-certification.”
- Time to market: A fast-paced development effort, which launched a completely overhauled product iteration from concept to sales in 15 months, on schedule, would never have been possible with an old paper system.
- Compliance: Electronic signatures and workflows with mandatory data requirements have improved documentation compliance. Also, the ability to efficiently pull up procedure, records, and approval history has been a great benefit in external compliance audits, such as a recent ISO 13485 re-certification resulting in no non-conformances.
- Efficiency: ECO cycle time reduced to less than five calendar days (not previously measured, but was much longer).
Alaine Portnoy is the senior marketing manager for Omnify Software.