Real-Time Data Streaming
Replace manual data collection that lands months after the campaign with live capture from instruments, MES and Zometric Edge. The data is in the dashboard before the batch is released.
Module 03 · Quality
Will your next APQR be ready the moment the inspector walks in?
For regulated pharma. The APQR stops being a months-long sprint and becomes a living document the inspector can open today. 21 CFR Part 11 e-signatures and audit trails on every action — compliance becomes the byproduct of doing the work.
What it does
Continuous Process Verification & APQR — what you actually get.
Six capabilities, each tied to a decision your team is already trying to make.
Live Control Charts
Continuous monitoring replaces offline statistical studies. CPV becomes a state you observe, not a study you run once a quarter.
Dynamic APQR
The static annual PDF becomes a living document that updates as the process runs. Always-audit-ready, always traceable to the underlying records.
Audit Trail on Every Action
21 CFR Part 11 e-signatures, complete user-action history per record. The audit trail isn't a deliverable — it's the byproduct of the system working as designed.
Digital Archive
Replace expensive paper archives with searchable digital storage. Retrieval that took weeks now takes seconds, with full lineage to the source measurement.
Anytime Inspection Readiness
When the inspector arrives, you do not prepare — you open the dashboard. Every record, every signature, every trend is one click away.
Standards & Compliance
Built for the standards your regulators and customers already require.
- 21 CFR Part 11
- ICH Q10
- US FDA cGMP
- ISO 13485
- 21 CFR 820
Better Together
Modules that work alongside this one.
Zometric's modules share a single data backbone — adopting more of them compounds the signal-to-noise advantage.
Module 02
In-Process Quality & SPC
Catch process deviations before they become defects.
Module 01
Statistical AI
The analytical brain — comprehensive statistics engine with AI-generated plain-language interpretations on every output.
Module 04
Gauge & MSA
Ensures measurement integrity across all sites and instruments.
Module 05
Inspection
Statistically valid lot acceptance — replacing paper and Excel inspection.
See CPV & APQR running on your line.
A 30-minute discovery call. A 2–3 week pilot on real factory data. Then scale at your pace.