Achieving Regulatory Compliance

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

Schedule a Phone Consultation

CHOSEN BY THESE CUSTOMERS...

Almac - Achieving Regulatory ComplianceBaxter Logo 2 - Achieving Regulatory ComplianceBD logo - Achieving Regulatory Compliancelogo1 - Achieving Regulatory Compliancelogo2 - Achieving Regulatory ComplianceBristol Myers Squibb 2020 - Achieving Regulatory ComplianceCSL Behring - Achieving Regulatory ComplianceDepuy Synthes - Achieving Regulatory ComplianceDentsply - Achieving Regulatory Compliancegetinge logo rgb 3000px - Achieving Regulatory ComplianceIntuitive - Achieving Regulatory ComplianceIvoclar Vivadent - Achieving Regulatory ComplianceJanssen logo - Achieving Regulatory ComplianceJohnson Johnson 1 - Achieving Regulatory ComplianceLeica Biosystems - Achieving Regulatory ComplianceMedtronic - Achieving Regulatory ComplianceNox Medical logo 1 - Achieving Regulatory ComplianceOriGen Biomedical - Achieving Regulatory CompliancePCI 1 - Achieving Regulatory ComplianceParexel - Achieving Regulatory CompliancePfizer - Achieving Regulatory CompliancePhadia - Achieving Regulatory CompliancePiramal Healthcare - Achieving Regulatory ComplianceSharp - Achieving Regulatory ComplianceTeva - Achieving Regulatory ComplianceUCB logo - Achieving Regulatory ComplianceSmith and Newphew 1 - Achieving Regulatory ComplianceSmiths Medical 1 - Achieving Regulatory ComplianceStryker 1 - Achieving Regulatory ComplianceThermoFisher Scientific 1 - Achieving Regulatory ComplianceZimmer 1 - Achieving Regulatory ComplianceAllergan Logo - Achieving Regulatory Compliance

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.

Read More