The launch follows a comprehensive customer engagement exercise between PRISYM ID and medical device manufacturing stakeholders – and is a focused direct response to the growing number of significant exposures and challenges that companies in the sector are facing.
As organizations seek to reduce the number of voluntary recalls caused by labeling and packaging defects – and in the process, mitigate the inherent damage to productivity, profitability, brand reputation and patient safety – companies are sometimes too slow in recognizing the need to take a more centralized approach to data management as the strategic solution to solving the Label Lifecycle challenge.
“Label design and delivery can no longer afford to sit in isolation,” says Darren Atkinson, CTO at PRISYM ID. “It is only one aspect in a 360° process – and to meet the highest standards of quality, accuracy and efficiency, it needs to be built upon a 360° view of all the variable data components that influence its content. In the highly regulated medical device environment, these variables include product specifications, country and product-specific regulations, market destination and local language requirements. What’s more, the regulatory landscape is constantly evolving. Label Lifecycle Management Systems must therefore evolve rapidly with it or face being a significant barrier to brand and market penetration.”
Alongside this, the globalization of the industry’s customer-base including the emerging BRIC countries is driving an increase in demand for multiple-page booklets, IFUs, and e-labeling. This is not only generating the need to meet additional country-specific language and regulatory requirements, it is exposing flaws in traditional labeling methodology and extensive incremental costs at a time when companies are seeking to control expenditure. These trends are placing emphasis on the need for solutions such as ‘on-demand’ printing to reduce wastage and build more flexibility into labeling processes.
“Research amongst our global client-base confirmed a more strategic approach to the management of data is required,” says Darren Atkinson. “Many spoke of the need for an integrated Label Lifecycle Management system that can capture, store and disseminate data safely, quickly and accurately. The release of PRISYM 360 embraces these needs; allowing companies to mitigate the costly risk of product recalls, expedite delivering local language labeling on demand and take control of label data across the enterprise.”
PRISYM 360 is a true web-based solution that supports multiple browsers and provides organizations with a holistic view of all their data assets. It provides a scalable platform designed to be rapidly deployed and validated without custom development due to its blend of pre-configured and configurable features.
The new solution helps companies consolidate, control and capture all instances of production label prints across manufacturing lines, distribution centers and third party manufacturers. This enables companies to manage electronic reconciliation across all printing operations within the system to satisfy regulatory auditors and management accountability ensuring a ‘single version of the truth’ to meet current and evolving regulatory requirements including UDI.
Darren Atkinson concludes, “PRISYM 360 promises to transform Label Lifecycle Management; delivering significant operational, productivity and efficiency gains to the medical device market. It will empower medical device companies to be agile and flexible in an ever-evolving marketplace.”