🚀  Currently in development — join the waitlist to get early access and founding pricing
AI-Powered · GxP Compliant · Built for Pharma

Catch calibration drift
before it becomes an
OOT or OOS event

The only CMMS built for pharma labs that turns your as-found and as-left calibration data into predictive intelligence — forecasting OOT events, enforcing TUR, and tracing impact across your entire calibration chain. Fully 21 CFR Part 11 compliant.

Designed for compliance with
21 CFR Part 11 FDA 21 CFR Part 820 ISO 17025 GMP / GLP / GCP USP <1058>

A Wake-Up Call

It's 2026. AI is writing code, diagnosing diseases, and driving cars.
So why is your lab still managing calibrations
in a spreadsheet?

Legacy CMMS platforms were built for work orders and schedules — not intelligence. They record what happened. They don't tell you what's about to happen. In a regulated pharma environment, that gap costs you batches, investigations, and audit findings. It's time for a CMMS that actually thinks.

The Problem

Calibration management is
broken in pharma labs

Spreadsheets, paper logs, and rigid intervals create compliance gaps and costly surprises.

📋

Data Entered, Never Used

Technicians diligently log as-found and as-left values — then that data sits idle. No trending, no predictions, no early warnings. Just a record of failures that already happened.

📂

Audit-Ready Chaos

Calibration records scattered across spreadsheets, binders, and siloed systems make FDA audit preparation a nightmare every single time.

⏱️

Manual Overhead

Lab teams spend hours chasing due dates, generating COCs, and reconciling instrument logs — time that should go toward science, not administration.

68%
of pharma labs still use spreadsheets for calibration tracking
$2.4M
average cost of a major calibration-related FDA recall
40%
reduction in calibration downtime with predictive scheduling
faster audit preparation with automated calibration records

The Platform

Everything your lab needs
in one intelligent system

01

Drift Trending

Every as-found and as-left value you log becomes a data point in a living drift model. Visualize how each instrument's bias shifts across calibration cycles and spot the ones quietly trending toward tolerance limits.

02

OOT Prediction

Using your manually entered calibration history, the AI predicts the probability and timeline of an Out-of-Tolerance event per instrument — so you can tighten intervals proactively instead of investigating failures reactively.

03

Reverse Traceability

When an instrument fails, instantly identify every batch, test result, and process that relied on it during its questionable period. Scope your investigation in minutes, not days.

04

TUR Enforcement & 21 CFR Part 11

Automatically validate Test Uncertainty Ratio compliance for every calibration event. Full electronic records, audit trails, and e-signatures — built to satisfy FDA inspectors on day one.

Instrument Status — Q2 2025
Mettler Toledo XSE205
INST-0041 · Analytical Balance
Calibrated
Agilent 1260 HPLC
INST-0078 · Chromatography
Due in 12 days
Thermo Fisher pH Meter
INST-0093 · Electrochemistry
Overdue
Sartorius BIOSTAT B
INST-0112 · Bioreactor
Calibrated
⚡ OOT Prediction
Agilent 1260 shows 14% drift acceleration over last 3 calibrations. 87% probability of OOT within 11 days. TUR ratio: 3.2 — below 4:1 threshold. Immediate review recommended.

How It Works

Up and running in days,
not months

No complex IT projects. No rip-and-replace. Designed to fit into how your lab already works.

01

Log Your Calibration Data

Technicians enter as-found and as-left values directly into the system. Clean, structured forms designed for how pharma labs actually work.

02

AI Learns Your Instruments

The model analyzes your as-found / as-left history to build drift profiles per instrument — the more data, the sharper the predictions.

03

Receive Smart Alerts

Your team gets proactive alerts ranked by risk — so you always know what to act on, and when.

04

Stay Audit-Ready

Every action is logged automatically. Generate full calibration histories and compliance reports in one click.

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