Three years ago, Oliver Medical, a leading medical packaging provider developing innovative sterile-grade packaging materials headquartered in Grand Rapids, MI, set out to find a solution to their ever-growing paper problem.
Lora Keena, Vice President of QA/RA, understood the importance of operating at the highest possible level of efficiency while not sacrificing safety, so she set out a goal to find an electronic solution to help establish real-time procedures that were easy to understand, train and update anywhere, anytime Oliver Medical personnel needed to do so.
She knew they had to move everything – forms, testing, and all quality systems – from paper to electronic. “Our old way was time consuming and cumbersome…we were faxing hard copies back and forth and it took forever,” Lora recalls.
There were four key requirements for a new electronic system:
- Reasonable price
- 21 CFR Part 11 compliance
- It had to meet their needs for document control
- Fast implementation
“We didn’t have 12 – 18 months implementation time. I didn’t want that kind of delay” said Keena.
Lora and her team narrowed down their search to four vendors and AssurX’s Software as a Service (SaaS) solution quickly rose to the top.