Forensic temperature excursion analysis for pharma batches that may or may not be compromised.
ColdChain Coroner reconstructs the complete thermal history of pharmaceutical shipments after an excursion event — ingesting raw IoT sensor logs, carrier manifests, and warehouse dwell-time data to produce stability impact assessments and FDA-ready deviation reports. It turns a 2am crisis into a defensible, documented decision. You either release the batch or you reject it, and either way you have evidence.
- Full thermal history reconstruction from fragmented, multi-source sensor data
- Correlates excursion windows against 47 pre-loaded ICH Q1A stability degradation profiles
- Native integration with MedTrak carrier manifest exports and EPCIS event streams
- Generates deviation reports pre-formatted to 21 CFR Part 211 and Annex 15 requirements
- Batch release/reject confidence scoring. Because someone has to make the call.
Sensitech TempTale, Controlant, Berlinger Smart, MedTrak, EPCIS 2.0, ColdStream Vault, AWS IoT Core, Salesforce Health Cloud, PharmaLedger, TraceLink Opus, NeuroSync Sensor API, SAP EWM
ColdChain Coroner is built as a set of loosely coupled microservices — an ingestion layer, a reconstruction engine, a scoring service, and a report renderer — all communicating over a hardened internal message bus. Thermal histories are persisted in MongoDB, which handles the complex nested excursion event documents far better than anything relational ever could. Redis stores the long-term stability profile reference data for sub-millisecond lookup during batch scoring. The whole thing runs containerized and can be deployed on-prem inside an air-gapped GxP environment in under an hour.
🟢 Production. Actively maintained.
Proprietary. All rights reserved.