Pharma · Global · 28 protocols
Clinical-trial chain-of-custody, proven to the regulator.
A top-5 global pharma needed defensible chain-of-custody and cold-chain integrity across 28 trial protocols.
The challenge
What they were up against.
Paper chain-of-custody
Custody for trial kits was paper-based and slow to reconstruct for audit.
Cold-chain risk
Temperature excursions risked the loss of high-value batches.
Weak audit readiness
21 CFR Part 11 audit readiness was inconsistent across protocols.
Our approach
Vendor-neutral, outcome-led.
We delivered continuous temperature, shock and location logging with sealed chain-of-custody and 21 CFR Part 11 electronic records, sharing events via EPCIS across 28 protocols.
How we solved it
What we delivered.
- Continuous temperature, shock and location logging
- Sealed chain-of-custody from depot to site to patient
- 21 CFR Part 11 e-records plus EPCIS sharing
Results
The outcome the board saw.
28
Trial protocols
21 CFR
Part 11
Global
Distribution
Audit
Defensible
Technology used
The stack behind it
RFID loggersCellular trackersEPCIS