Evana Automation Specialists, a leading Systems Integrator and builder of custom, automated assembly and test systems, recently launched a new validation program to assist healthcare product manufacturers with meeting FDA regulations during the process of implementing automated manufacturing equipment. The Evana Validation Process (EVP) was designed to help healthcare product manufacturers avoid costly mistakes – such as overlooking critical requirements that could result in production downtime, bridge departmental silos, keep the entire product management team on the same page, as well as expedite time-to-market.
EVP is exclusive to Evana Automation customers. The process begins with the initial engagement, continues through the design and build process, and concludes with the Site Acceptance Test (SAT). In addition, Evana provides support with IQ/OQ/PQ (Installation Qualification, Operational Qualification, and Performance Qualification) initiatives upon request.
“Inadequate validations are one of the top reasons healthcare product manufacturers get issued an FDA Form 483,” said Oscar Ford, Healthcare Business Development Manager at Evana Automation Specialists. “Evana goes the extra mile to help healthcare product manufacturers align with FDA regulatory requirements and expedite time-to-market. Best of all, EVP has already proven to be a tremendous success with several high profile medical device manufacturers over the past 12 months.”
For more information about EVP, visit http://www.evanaautomation.