FDA UDI, EU MDR, FDA PART 11, EU Clinical trials
regulations can be easily implemented with the right
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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.
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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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.
REGULATORY AND COMPLIANCE LABELING RESOURCES
EU MDR Labeling Compliance: Learn the Lessons from UDI. Date: 05 December 2017; 3PM GMT / 4PM CET
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.
READ OUR LATEST REGULATORY AND COMPLIANCE LABELING BLOGS
- Survey reveals that only 17% of the respondents are aware of the changes that come with the EU MDR
- Clinical Trials: Managing Labeling Approvals with Multi-Language and Multi-Region Regulations
- Clinical trials: when the label became more significant than the drug itself…
- Top three challenges in clinical trial packaging and labeling operations