TempEZ™ offers clients a single database to store temperature data from product manufacture to patient administration, as well as providing a platform to ensure compliance to cGXP and GDP regulations.
TempEZ™ is designed to upload temperature data from numerous monitor brands. It also allows any stakeholder in the client’s clinical or commercial supply chain to upload temperature monitor data and record planned and unplanned excursions at a lot or serialized level.
These features allow clients to use their preferred vendors and monitors.
High level features of TempEZ™ include:
- Create and manage monitor profiles and product stability data
- Program monitors
- Register shipments (Almac and non-Almac)
- Collect temperature data from in-transit and site monitors
- Record, report and adjudicate in-transit and site excursions
- Tracking of excursions at a lot or serialized level
- Record planned excursions
- Integration with IRT providers
- Reporting and advanced analytics
Benefits of TempEZ™ include:
- Temperature data from manufacture to patient administration is all in one place
- Easy to use platform to support GDP compliance
- Ability to build a complete temperature history for a product at a lot or serialized level
- Controlled, quality approved process for adjudication
- Ability to expedite the removal of out of specification drugs
- Ability to run analytics across key performance factors and make changes to improve internal and vendor performance
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