“Since going live, we have successfully utilized the extensive data collection, analysis and reporting features to meet the needs of many plant areas, including Manufacturing, Facility Conformance, Maintenance, QC, and upper-management. The system has provided an excellent means for troubleshooting system failures and analyzing long-term process performance. Using this system, we have estimated that we detect and fix 'problems' before they become 'major problems' roughly 6 times per year. Analysis of system problems is often performed off-hours by our technical people from home using a laptop.

Use of the system to automatically analyze and create reports for parametric release of our terminally steam-sterilized product saves us hundreds of thousands of dollars each year in material and testing costs, reduces the time to review and document each product batch from 45 minutes to 3 minutes, and very obviously finds problems that would otherwise go undetected.

The system has been inspected by the FDA and meets all our 21 CFR Part 11 requirements (it even pulls our non-compliant systems within a Part-11 compliant umbrella -- which is great, considering that upgrading and revalidating these (perfectly good) control systems was not feasible or cost-effective).

Novinity Software has provided what we consider to be world-class support. Their programmers are among the best we've contracted. They never quibbled about price, their work was completed on-time, and their validation expertise is excellent.”

“We are extremely satisfied. And you can quote us on that....”

Bryan Petrofsky, Mark Spinelli, Tyco Healthcare/Mallinckrodt