Cold Chain Validation

Excursion investigations
take 8-14 days.
ProofKit takes 30 seconds.

Upload your data logger CSV. Get a GDP-compliant excursion report with MKT calculation, severity classification, temperature profile chart, and SHA-256 integrity hashing. No proprietary software required.

Validate Your Data → View Sample Certificate
The Problem

$35 Billion Lost Annually to Cold Chain Failures

Your data loggers collect millions of readings. Almost none become auditable proof. When an excursion happens, QA teams spend days stitching together reports manually.

"Teams still stitch together CSVs, PDFs, and audit binders to investigate a single excursion event."

-- Pharma cold chain operations, describing the current state of excursion investigation documentation
$35B

Annual pharma cold chain losses

Temperature excursions during storage and transport destroy billions in pharmaceutical products annually. Vaccines, biologics, and temperature-sensitive drugs are all at risk.

99.86%

Data blindness with manual logs

Twice-daily manual readings capture 2 data points out of 1,440 minutes. A freezer failure at 2 AM Sunday will not be discovered until Monday morning. CDC found up to 76% of VFC providers exposed vaccines to out-of-range temperatures.

10,000+

Hours per year processing alerts

Large pharmaceutical operations spend thousands of hours annually investigating temperature alerts. Each investigation requires executive summary, timeline, temperature plots, root cause analysis, and disposition decision.

8-14 days

Per excursion investigation

Traditional excursion investigations take 8-14 days. QA must manually dig through logs and spreadsheets, assemble reports, and obtain sign-offs. Product sits in quarantine, tying up inventory and delaying shipments.

Sound familiar?

How It Works

Three Steps. Thirty Seconds.

No software to install. No hardware to buy. Works with your existing data loggers.
1

Export CSV From Your Logger

Download the temperature data from your existing data logger as a standard CSV file.

Compatible: HOBO, EasyLog, MadgeTech, Sensitech, LogTag, Dickson, any CSV
2

Upload to ProofKit

Set your storage range (e.g., 2-8C), sensor uncertainty, and monitoring window. Or select a cold chain preset.

Pre-configured: USP 797, CDC VFC, GDP 2-8C, GDP 15-25C, custom
3

Download Compliance Report

Receive a signed PDF with PASS/FAIL verdict, MKT, excursion analysis, temperature profile chart, and SHA-256 evidence bundle.

Output: PDF certificate + evidence.zip with manifest
Certificate Contents

What Your QA Team Receives

Every certificate is a complete excursion investigation package, ready for GDP inspection.
  • PASS/FAIL verdict -- clear determination against specified storage range
  • Temperature profile chart -- time-temperature curve with storage range lines and shaded excursion intervals
  • Mean Kinetic Temperature (MKT) -- cumulative thermal stress per USP 1079
  • Excursion analysis -- duration, magnitude, severity classification for each deviation
  • Storage specification box -- target range, sensor uncertainty, monitoring window
  • Statistical summary -- min, max, mean, standard deviation, time in range percentage
  • QR verification code -- scan to verify certificate integrity online
  • SHA-256 evidence bundle -- manifest with per-file hashes and root hash for tamper detection
  • Original CSV preserved -- raw data included in evidence.zip for full traceability
ProofKit Certificate
Cold Chain Storage Validation
FAIL
fridge_unit_03_feb2026.csv
Storage Range
2.0 - 8.0 C
MKT
9.4 C
Excursion Duration
2h 14m
Peak Excursion
12.3 C
Time In Range
96.8%
Integrity
Verified
sha256:b7d1f3...
Standards Compliance

Documentation Your Regulators Expect

ProofKit validates against the standards that govern pharmaceutical storage and distribution.
USP 797
United States Pharmacopeia chapter on pharmaceutical compounding. Requires continuous temperature monitoring and documentation of storage conditions for compounded preparations.
CDC VFC
Vaccines for Children program. Requires continuous digital data logger monitoring with min/max readings, excursion documentation, and corrective action records.
EU GDP
Good Distribution Practice for medicinal products. Requires temperature mapping, continuous monitoring during storage and transport, and complete deviation investigation records.
21 CFR Part 11
FDA regulation on electronic records and signatures. Requires validated systems, audit trails, record integrity, and security controls. ProofKit provides SHA-256 integrity hashing and QR verification.
WHO PQS
World Health Organization Performance, Quality and Safety standards for immunization supply chains. Defines cold chain equipment performance and monitoring requirements.
Comparison

ProofKit vs. The Alternatives

Enterprise monitoring platforms cost $5K+ per year and require multi-month implementations. Excel investigations take 8-14 days each.
Feature ProofKit Excel (Manual) Vaisala viewLinc Sensitech / Eupry
Works with any data logger CSV Yes Yes No -- Vaisala probes only No -- vendor-locked
Report in < 60 seconds Yes No -- 8-14 days Hours Hours
MKT calculation Yes No -- manual calc Yes Yes
SHA-256 tamper evidence Yes No No No
AI-powered analysis Yes No No No
No hardware required Yes -- web-based Yes No -- Vaisala probes No -- vendor hardware
Implementation time Instant Instant Weeks to months Weeks to months
Price $149/mo Free (labor cost) $5,000+/year $5,000+/year
AI Analysis

ProofKit Doesn't Just Validate. It Explains.

Traditional monitoring systems give you alerts. ProofKit gives you the investigation narrative your QA team needs.
Before: Raw Alert Output
Result: FAIL
Min: 1.2 C | Max: 12.3 C
MKT: 9.4 C
Excursion: 2h 14m above 8.0 C
Time In Range: 96.8%
After: ProofKit AI Analysis

Excursion Investigation Summary: A sustained temperature excursion was detected between 02:14 and 04:28 on Feb 18, 2026. Temperature peaked at 12.3C, exceeding the 8.0C upper limit by 4.3C for 2 hours 14 minutes.

MKT of 9.4C exceeds the 8.0C specification, indicating cumulative thermal stress above acceptable limits for the monitoring period. 96.8% time-in-range suggests the excursion was an isolated event rather than systematic drift.

Recommendation: The excursion timing (02:14 AM) and pattern (rapid rise followed by gradual recovery) is consistent with a door-ajar event or defrost cycle failure. Inspect door seal and defrost timer. Product stability assessment is required for disposition decision.
Pricing

Pays for Itself After One Excursion

Start free. Upgrade when your volume requires it.

Professional

$149/mo
100 certificates per month
  • All industry templates
  • AI-powered analysis
  • MKT calculation
  • No watermark
  • SHA-256 evidence bundles
  • Priority email support
Get Professional

Business

BEST VALUE
$349/mo
500 certificates per month
  • Everything in Professional
  • Batch processing
  • API access
  • Multi-user accounts
  • Custom report branding
  • Phone support
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ROI Calculator: Cold Chain

1
excursion investigation
=
8+ hours
QA labor
×
$50/hr
QA analyst rate
=
$400+
per incident saved
→
ROI after 1 incident
at $149/mo
FAQ

Frequently Asked Questions

How does ProofKit calculate Mean Kinetic Temperature (MKT)?

ProofKit calculates MKT using the Haynes equation as defined in USP 1079. MKT is a single temperature value that represents the cumulative thermal stress on a product over the monitoring period. It accounts for the disproportionate impact of higher temperatures on product degradation, making it more conservative than a simple average. ProofKit computes MKT automatically from your CSV data and includes it in the certificate alongside min, max, mean, and standard deviation.

How does ProofKit determine excursion severity?

ProofKit classifies excursions by both duration and magnitude. A brief excursion (under 15 minutes, less than 2 degrees outside the specified range) is classified differently than a sustained excursion (over 1 hour, more than 5 degrees outside range). The severity classification is documented in the certificate to help QA teams prioritize investigations and make disposition decisions based on objective, repeatable criteria.

Is ProofKit compliant with 21 CFR Part 11?

ProofKit generates tamper-evident certificates with SHA-256 integrity hashing and QR-based verification, which aligns with Part 11 requirements for electronic records integrity. No system is Part 11 compliant out of the box -- compliance requires a documented program on top of the technology. ProofKit provides the technical controls (integrity hashing, verification, evidence bundles). Enterprise plans add retention policies and audit trail capabilities.

Can ProofKit generate stability assessment documentation?

Yes. ProofKit's AI analysis includes stability impact assessment based on excursion duration and severity. The certificate documents the thermal exposure profile, MKT, and deviation from specified storage conditions -- exactly the data your QA team needs to make a disposition decision. The AI narrative is formatted for inclusion in formal GDP investigation reports.

Does ProofKit support GDP investigation report format?

GDP investigations require executive summary, timeline, temperature plots, root cause analysis framework, stability assessment, and disposition decision documentation. ProofKit generates the data-driven components automatically: timeline, temperature plots, excursion analysis, MKT calculation, and severity classification. The AI analysis provides a narrative summary suitable for the executive summary section of formal investigation reports.

Which data loggers are compatible with ProofKit?

ProofKit works with any data logger that exports CSV files with timestamp and temperature columns. This includes HOBO (Onset), EasyLog (Lascar), MadgeTech, Sensitech TempTale, LogTag, Dickson, and any SCADA or BMS system that exports CSV. No proprietary software is required. If your logger exports CSV, ProofKit can read it.

Your next GDP inspection is coming. Be ready.

Upload your storage data. Download a report that holds up under regulatory review.

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