We offer a scalable and validatable solution designed
to be used globally across your organization
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As organizations grow by responding to emerging global market opportunities, their existing systems and processes may be too inflexible to adapt to support new product/business lines with specific functionality demands.
In addition, extending IT systems to new geographic regions, or scaling capacity or performance to support growing teams, may often be subject to technology barriers, delays or significant capital investment.
More importantly, entry into new markets or geographies may introduce new regulatory demands on an organization that need to be addressed quickly and efficiently.
How we helped one of our clients with this challenge:
- Indiana, USA based manufacturing organization with 20 sites
- Challenged with integrating acquisitions and time-to- market
- Implemented our centralized solution with all site users and 3rd party access to labeling
- Significant reduction in new acquisition on-boarding effort
- Huge reduction in time-to-market and minimized labeling error risks.
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OFFERING THESE PRODUCTS AND SERVICES...
This solution provides organizations with complete label integrity to meet the strictest compliance requirements for FDA & EU regulations, specifically FDA 21 CFR Parts 11, 810, and 820.
ENABLING EXPANSION LABELING RESOURCES
Discover how PRISYM ID helped Boston Scientific, one of the world’s largest medical device manufacturers, who was looking to standardize on a single labeling system.
The introduction of Unique Device Identification (UDI)regulations signals a seismic shift in the labeling of medical devices. Over the past twenty years, the development of labeling solutions for the highly regulated devices sector...