UL’s ComplianceWire® Emergency Use Qualification is now available for vaccine developers and manufacturers to expedite the qualification of licensed or contracted manufacturers, helping them maintain the integrity and quality of their vaccine regardless of manufacturer. It is also available for governmental bodies to maintain public trust by providing proof that individual administrators are qualified to safely dispense COVID-19 vaccines.
ComplianceWire® Emergency Use Qualification are streamlined and purpose-built instances of ComplianceWire®, UL’s best-in-class, web-based platform designed specifically for medical device, pharmaceutical and biologics industries to effectively and efficiently automate the creation, delivery, and reporting of role-based training, qualification and compliance programs. ComplianceWire® was built from the ground up to be fully compliant with 21 CFR Part 11 and EU Annex 11 validation requirements. This time-tested technology is used extensively by U.S. and global medical device, pharmaceutical, and biologics companies as well as global regulatory authorities in the U.S., China and India.
ComplianceWire® Emergency Use Qualification features and benefits:
- Rapid implementation
- Part 11 compliant records and E-signatures
- Intuitive user interface
- Automated role-based assignment of training
- Version-controlled content with periodic review workflow
- Granular and flexible security role definitions
- Robust audit trails
- Real-time reporting and data visualizations
- External systems integration