Operations & Labeling

IS YOUR ROLE OPERATION OR LABELING?

Being on the operational side of the business, the onus is on you to ensure all regulations are met. Attention to detail is essential from you and your team, from printed labels and leaflets to data sheets and more.

We provide labeling solutions designed to:

  • streamline procedures
  • reduce risks by discovering defects in manufacturing
  • simplify design approvals
  • give a single source of the truth

By using our labeling solution, your legal requirements and regulations will be met; and the number of product recalls, system failures and technical challenges will diminish. Our solutions safeguard against human error, simplifying the process of monitoring compliance.

We guarantee speed and accuracy. All label design and production will be implemented in single process; the business insight that come with our software will give you full control and visibility of content, design workflows and labeling output.

“Since implementing a single solution strategy, we have started to see an improvement in the process – not only do we have the assurance of regulatory compliance but we now have a robust platform to drive operational efficiency and increase productivity. The team has also been good at listening to our feedback – particularly in terms of functionality. The support and ongoing maintenance has made the project very successful.”

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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OPERATIONS AND 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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