Enabling Expansion

ENABLING EXPANSION

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.

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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.

CHOSEN BY THESE CUSTOMERS...

OFFERING THESE PRODUCTS AND SERVICES...

PRISYM 360

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.

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PRISYM SaaS

This solution enables organizations to address the challenges of complying with FDA and other regulations by delivering access to a compliance ready platform in the Cloud.

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SERVICES

Our team of in-house compliance and validation subject matter experts and professional services and support teams can support you from implementation through beyond delivery.

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ENABLING EXPANSION LABELING RESOURCES

Aligning For Growth whitepaper 2 - Aligning For Growth: The Evolution Of Medical Device Labeling Aligning For Growth: The Evolution Of Medical Device Labeling Posted in: Assisting With The Consolidation, Business Analysis, Enabling the Expansion, Medical Device, Operations & Labeling, Supply Chain, Whitepaper -

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...

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