INTEGRATED, AUTOMATED PRINT INSPECTION FOR MEDICAL DEVICE AND CLINICAL TRIAL LABELING
PRISYM 360 Vision to help remove risk of print errors, reduce costs and ensure compliance
We are announcing the general availability of PRISYM 360 Vision, a new automated print inspection module for our flagship PRISYM 360 labeling platform. PRISYM 360 Vision delivers the industry’s only label lifecycle management software to be fully integrated with print inspection hardware, reducing costs and removing risk whilst ensuring regulatory compliance.
As regulations tighten, the need for medical device manufacturers to examine their systems, processes and operations is intensifying. The roll-out of Unique Device Identification (UDI) requirements is placing unprecedented levels of scrutiny on the labeling of medical devices; companies must ensure that label content is aligned with FDA requirements.
Simon Jones, VP Global Product, PRISYM ID, comments: “Despite advances in labeling technologies, a surprisingly high percentage of companies still rely on either manual inspection of medical device labels, or disparate systems for label production and print inspection, both of which are clearly time and resource intensive, and leave organizations open to risk of print error and non-compliance.”
As a fully integrated solution, PRISYM 360 Vision overcomes these constraints by automating the creation of inspection masks through the label design software, which in turn also makes the training of the print inspection hardware a significantly easier process. In doing so, PRISYM 360 Vision allows organizations to perform inspections on both label design and specific label content in real-time through the PRISYM 360 user interface, whilst inspection results are automatically recorded in a single, secure electronic audit log. The result is a seamless process for verifying the accuracy, quality and compliance of the printed medical device and clinical trial label.
Jones adds, “With a recent PRISYM ID survey indicating that only 40% of companies polled are confident that they are ready for an FDA inspection that includes UDI activities, the need for organizations to be assured of their label compliance has arguably never been greater. PRISYM 360 Vision removes all the constraints of traditional print inspection processes. It reduces the cost, effort and expertise associated with the management, configuration and testing of disparate print hardware solutions, making them truly viable for widescale adoption. This reduces risk as more errors will be detected and rectified; and, critically, improves compliance and auditability.”
“At PRISYM ID, we take pride in delivering real-world technology that addresses our clients’ most pressing needs. We have made a significant investment in understanding the specific workflows and processes involved with the print inspection process, and are very pleased to present PRISYM 360 Vision as our latest solution to help medical device and clinical trial organizations achieve compliance.”