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Producing labels and artwork which are accurate, up-to-date, and compliant with country-specific regulations is fraught with risk. As content changes, it needs to be revised, approved, released at the correct time and included in the correct labels/artwork.
As organizations within life sciences industry increasingly operate on a global basis, issues such as local language labeling – especially those where languages will have different character sets – accurate translation of IFUs (Instructions For Use), and ensuring both words and images comply with country-specific regulations all pose risks that traditional, silo-based systems may struggle to accommodate.
If these changes are not requested and controlled effectively, the risk that production labels, artwork, PILs (Patient Information Leaflets) or IFUs will contain errors is increased and will result in many recalls and huge cost to the business.
How we helped one of our clients with this challenge:
- New England, USA headquartered Medical Device company
- Significant cost overhead when implementing global label changes, with a minimum of 4 per year
- Centralized system implemented including impact analyses for change control reduced the time to find, and implement label changes
- Estimated cost savings of $350K per global label change equaling $1m+ per year
- Associated reduction in risk of the wrong label being printed at the time of production and faster route to market.
CHOSEN BY THESE CUSTOMERS...
OFFERING THE PERFECT OPTION FOR YOU
Label and Artwork Management Solution for Medical Device, Clinical Trials and Pharmaceutical sectors.
We offer tiers of deployment to suit your needs and size of the business. But our offer is much more than just deployment.
We are the only software vendor in life science industry who supplies in- house validation documentation and implementation support.
REDUCING RISKS LABELING RESOURCES
Discover how PRISYM ID helped Origen Biomedical, a growing medical device manufacturer, who was looking for a cost effective and easy to use label printing process.
The continual tightening of regulation around the packaging and labeling of medical devices has so far failed to stimulate a transformation of labeling infrastructure and approach among global device manufacturers.