Medical device firm extends BIO-key deployment
01 September 2020 11:57 GMT

BIO-key, a provider of identity and access management (IAM) solutions powered by biometrics, today announced that its long-time customer, global medical device manufacturer ICU Medical, Inc., has expanded its use of BIO-key biometric authentication to its new staff training program, streamlining check-in and automating FDA compliance recordkeeping.

ICU Medical has been successfully using BIO-key biometric authentication solutions since 2005, initially to streamline and automate an FDA-regulated Quality Control (QC) signoff process within Oracle ERP during product manufacturing. This lean-process innovation shaved significant time off the production of their infusion products while ensuring in real-time that the signing QC staff member was properly authorized and trained to perform the specific QC process, compliant with Code of Federal Regulations (CFR) 21 part 11.

As ICU Medical has grown over the past 15 years, BIO-key biometric authentication has enabled the company to seamlessly add users and worldwide locations without having to buy, issue, or track any physical tokens for each staff member. The integration of BIO-key has greatly simplified ICU Medical’s onboarding and offboarding process.

Recently, ICU Medical wanted to add a secure, user-friendly method to authenticate access to iLearning, a staff training platform from Seertech that incorporates content, accounting, and reporting functions. They leveraged the existing successful BIO-key authentication platform for a larger group of users and are seeing the benefits in terms of faster training sign-ins, simplified accounting, and a better user experience.

“We are thrilled to see ICU Medical finding new ways to streamline operations using their investment in BIO-key’s one-touch, strong authentication,” stated Jim Sullivan, BIO-key SVP of Strategy and Chief Legal Officer. “By adding BIO-key efficiency to their digital learning initiatives, the company simplified the process of maintaining its training requirements, while providing its employees with the tools to make their jobs easier.”