The FMMC’s annual Florida Medical Device Symposium is just around the corner!
I am attending the Florida Medical Device Symposium May 6th-7th in St. Petersburg. We will be co-exhibiting with our partner in the Tampa area, Prism Plus Consulting. This will be our third year as an exhibitor with Mary McCoy, President of Prism Plus Consulting. FMMC has put together a full agenda for the expected 150 attendees. Conference topics will include the state of the medical device industry, regulatory compliance, litigation, Unique Device Identifier System and contract manufacturing.
ColumbiaSoft has a growing base of bioscience customers that use our software for document control, workflow, and auditing. According to the latest Battelle Bioscience industry report Florida is one of the top five states in this sector.
Our exhibit this year will highlight the new document change control repository (DCC) we’ve created for the biotech market. It provides an out of the box structured methodology that automates the traditional manual document change control procedure. The system has been designed so that Process Owners have end-to-end responsibility for their documents. Process owners design the process, and process teams carry it out, overseeing their own work and making all the day-to-day operating decisions required to keep things moving smoothly. Process teams are composed of individuals who have broad process knowledge. The system manages the complete lifecycle of a document: template management, document change request, creation/edit, review, approval, training, distribution, archive and obsolescence, in compliance with ISO standards and 21 CFR Part 11. System validation is facilitated by a comprehensive set of validation scripts.