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

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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REGULATORY AND COMPLIANCE LABELING RESOURCES

EU MDR EU MDR’s Impact on Labeling: UDI in Europe and Other Changes Posted in: Achieving Regulatory Compliance, Business Analysis, Medical Device, Operations & Labeling, Project Managers, Reducing Risks, Regulatory & Compliance, Supply Chain, Webinar -

Join medical device labeling and data experts from PRISYM ID and Reed Tech to learn about what the EU Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) mean for labels in this free webinar.

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EU MDR Infographic 10 Sticking points Infographic - Medical Device Label Before and After EU MDR – 10 Sticking Points Medical Device Label Before and After EU MDR – 10 Sticking Points Posted in: Achieving Regulatory Compliance, Business Analysis, Infographic, Information Technology, Medical Device, Operations & Labeling, Project Managers, Regulatory & Compliance, Supply Chain -

EU MDR introduces additional information that needs to be included on labels, forcing organizations to design new label templates that make room for data not previously part of the labeling system.

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