Temperature Excursion Adjudication

Reference Architecture: Remediating a cold chain monitoring spreadsheet into a validated system with automated file ingestion and real-time alerts.

The Archetype: The "Cold Chain Log"

In pharmaceutical logistics, the "Last Mile" is often the riskiest. When a shipment of temperature-sensitive biologics arrives at a warehouse, the standard operating procedure often involves a manual hand-off that breaks the digital chain of custody.

The typical workflow involves the "Cold Chain Log" spreadsheet.
Warehouse operators remove data loggers (e.g., TempTales) from shipping containers, download the data to a local PC, view the PDF report, and then manually transcribe the maximum temperature and duration into an Excel tracker. They then consult a separate paper SOP to determine if the excursion is acceptable based on the product's stability budget.

The Compliance Gap

While the data loggers themselves are validated devices, the human decision process surrounding them is fraught with risk.

  1. Transcription Error: 21 CFR 211.68 requires verification of input data. When a human reads "8.5°C" from a PDF and types "5.8°C" into Excel, the error is often undetectable until a later audit.
  2. Algorithmic Failure (MKT): Determining the severity of an excursion often requires calculating Mean Kinetic Temperature (MKT), a complex non-linear formula derived from the Arrhenius equation. Implementing MKT correctly in Excel cells is notoriously difficult and prone to corruption if a user accidentally modifies a range reference.
  3. Disconnected Evidence: The raw data (the CSV/PDF from the logger) sits in a folder on a shared drive. The decision ("Released") sits in a spreadsheet. There is no immutable link between the source data and the quality decision.

The Risk: Accepting a spoiled shipment due to a typo, or quarantining good product due to a calculation error.

The Solution: The ValidKeep™ Ingestion Engine

The ValidKeep remediation strategy for logistics focuses on removing human data entry from the loop. We replace the "Log" with a Validated Decision Engine.

Here is the Reference Implementation for this automated workflow:

Phase 1: Direct File Ingestion (Removing the Keyboard)

Instead of asking operators to type numbers, the ValidKeep application provides a secure "Drop Zone."

  • The Workflow: The operator connects the logger and drags the raw .csv or .txt export file directly into the browser.
  • The Logic: The system parses the file server-side. It extracts the Serial Number, Start/Stop times, and the 10,000+ individual temperature readings instantly.
  • Compliance: This eliminates transcription risk entirely. The system validates the file structure and checksum before processing.

Phase 2: Validated Algorithmic Assessment

We replace fragile Excel formulas with Frozen, Unit-Tested Logic.

  • MKT Calculation: The application applies a validated MKT algorithm to the raw data points. This code is locked and cannot be altered by the user.
  • Dynamic Stability Profiles: Instead of the operator looking up a PDF rule, the system looks up the "Validation Control Matrix" for that specific SKU.
    • Logic Example: "If Product = Vaccine X, Fail if > 8°C for 30 mins."
    • Logic Example: "If Product = Tablets Y, Fail if MKT > 25°C."

Phase 3: The "Original Record" Vault

FDA guidance on Data Integrity emphasizes the preservation of "Original Records."

  • The Archive: Upon ingestion, ValidKeep automatically uploads the raw logger file to the Cryptographic WORM Vault (R2).
  • The Link: The database record for "Shipment #123" is permanently cryptographically linked to that specific raw file. The evidence cannot be lost, deleted, or separated from the decision.

The Target State

By migrating from the "Cold Chain Log" to ValidKeep, the warehouse achieves Good Distribution Practice (GDP) compliance by design:

  1. Instant Adjudication: The system provides an immediate PASS (Green) or QUARANTINE (Red) signal based on the validated logic. The operator does not need to do math; they just need to follow the signal.
  2. Audit-Ready History: When an auditor asks, "Why was shipment #554 released?", the Quality Director clicks one link. They see the user who uploaded it, the timestamp, the calculated MKT, and the original raw file from the logger.
  3. Real-Time Visibility: Unlike a spreadsheet on a local drive, the ValidKeep Dashboard allows Central Quality to see excursion trends across all warehouse sites globally in real-time.

Conclusion

Manual data entry in 2026 is a compliance liability. By wrapping the raw data ingestion in a validated envelope, ValidKeep ensures that the physical reality of the shipment is accurately reflected in the quality record, untouched by human error.