COMPLIANCE CAN BE EASY TO ACHIEVE
FDA UDI, EU MDR, FDA PART 11, EU Clinical trials
regulations can be easily implemented with the right
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IS YOUR ROLE REGULATORY OR COMPLIANCE?
Ensuring that your company is fully compliant with all required laws and regulations, is not only fundamental but also incredibly time-consuming. However, as important, is ensuring you remain fully up-to-speed on all aspects of legal change.
Our internal regulatory experts quote: “If you cannot prove it, it did not happen.”
We understand that you need to be supported by highly efficient Label Management Software and documentation for all aspects of compliance - from FDA 21 CFR Part 11, Audit logs, Approval Workflows, Language and Phrase Controls, Print Inspection, and Versions Control to Regulatory Rules and Security.
We support every element of validation - from initial installation to final performance testing. Our software can be supplied as a validated package, including auditable security protocols and lifecycle documentation, based on the GAMP 5 model.
“Security and regulatory compliance is of paramount importance in medical device manufacturing. PRISYM ID’s labeling system is able to provide us with the correct level of service and security we require, whilst being userfriendly.
The install of the system into our clean room went smoothly and we have been pleased with the results.”
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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.
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 BLOGS
- What to do if you get an FDA Recall
- 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…