FDA UDI, EU MDR, FDA 21 CFR Part 11, EU Clinical trials
regulations compliance can be easily achieved with the right
Let us help you
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
CHOSEN BY THESE CUSTOMERS...
OFFERING THE PERFECT OPTION FOR YOU
Label and Artwork Management Solution for Medical Device, Clinical Trials and Pharmaceutical sectors.
We offer tiers of deployment to suit your needs and size of the business. But our offer is much more than just deployment.
We are the only software vendor in life science industry who supplies in- house validation documentation and implementation support.
REGULATORY AND COMPLIANCE LABELING RESOURCES
Join industry experts from PRISYM ID and GS1 to learn about the new GS1 Clinical Trial barcode standards and the benefits of adopting AI (7240).
Changing regulations, such as Annex VI clinical trial regulation, need to be incorporated into the label and artwork processes in time for when the regulation takes effect.