Achieving Regulatory Compliance

COMPLIANCE READY

FDA UDI, EU MDR, FDA 21 CFR Part 11, EU Clinical trials
regulations compliance can be easily achieved 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 , FDA 21 CFR Part 11 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.

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

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OFFERING THE PERFECT OPTION FOR YOU

LABELING SOFTWARE

Labeling Software icon - Achieving Regulatory ComplianceLabel and Artwork Management Solution for Medical Device, Clinical Trials and Pharmaceutical sectors.

DEPLOYMENT

Deployment icon 02 - Achieving Regulatory ComplianceWe offer tiers of deployment to suit your needs and size of the business. But our offer is much more than just deployment.

SERVICES

Services icon - Achieving Regulatory ComplianceWe are the only software vendor in life science industry who supplies in- house validation documentation and implementation support.

REGULATORY AND COMPLIANCE LABELING RESOURCES

EU MDRS 12 Month Reprieve Thumbnail - Achieving Regulatory Compliance EU MDR’s 12 Month Reprieve Posted in: Achieving Regulatory Compliance, Medical Device, Regulatory & Compliance, Whitepaper -

Due to Covid-19, on 17th April 2020, the European Parliament gave Medical Device companies a 12-month reprieve on EU MDR.

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