Enabling Expansion

SCALABLE SOLUTION

We offer a scalable and validatable solution designed
to be used globally across your organization

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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

EU MDR infographic - EU MDR – Is the Industry Planning for It? Are You? EU MDR – Is the Industry Planning for It? Are You? Posted in: Achieving Regulatory Compliance, Business Analysis, Infographic, Information Technology, Medical Device, Operations & Labeling, Project Managers, Regulatory & Compliance, Supply Chain -

Whether you’re producing medical devices within Europe or supplying to Europe from the rest of the world, as a manufacturer or supplier, you will need to adhere to the EU MDR by May 2020.

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