Achieving Regulatory Compliance

VALIDATION READY

FDA UDI, EU MDR, FDA PART 11, EU Clinical trials
regulations can be easily implemented with the right
labeling solution

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ACHIEVING REGULATORY COMPLIANCE

The regulatory requirements for the life sciences industry create specific operating challenges. All label and artwork production systems and processes/output need to comply with regulations for each country or region in which products are supplied.

Changing regulations, such as evolving UDI, EU MDR and the EU clinical trial regulations, need to be incorporated into these label and artwork processes appropriately, and in time for when the regulation takes effect.

Finally, the label and artwork systems and operating procedures are subject to audit by regulators to ensure compliance.

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How we helped one of our clients with this challenge:

  • Tier 1 Global Medical Device manufacturer
  • Experienced issues with incorrect data on production labels which resulted in multiple recalls
  • Implemented our enterprise label lifecycle management solution
  • Automated label production with integrated data feeds and handling data once! Giving one source of the truth
  • Achieved zero-defect labels with full compliance and realized $19m savings in

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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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REGULATORY AND COMPLIANCE LABELING RESOURCES

PRISYM ID 10 Steps to EU MDR Labeling Implementation Guide 10 Steps to EU MDR Labeling Implementation Posted in: Achieving Regulatory Compliance, Medical Device, Operations & Labeling, Project Managers, Regulatory & Compliance, Whitepaper -

Whether you’re producing medical devices within Europe or supplying to Europe, as a manufacturer or supplier, you will need to adhere to the new EU MDR.

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