Built for Pharma GxP & Vaccine QC

GxP cleanroom sterility & vaccine lot verification.

Execute 21 CFR Part 11 sterility audits, monitor cold-chain temperatures, record pre/post vaccine delta titer readings, and log breakthrough infections.

Cleanroom Sterility, Cold-Chain Temperature, and Vaccine Lot Efficacy

GxP cleanroom sterility & vaccine lot verification.

How iNSPECS works

A pharma gxp & vaccine qc workflow your teams can follow on mobile or desktop.

Step 1

Vaccine lot registration

Record manufacturer lot numbers, expiration dates, and target dosages.

Step 2

Cold-chain temp audit

Verify ultra-low freezer storage and transport temperature logs.

Step 3

Delta titer lab reading

Input baseline and post-vaccine antibody titers to compute efficacy.

Step 4

21 CFR Part 11 sign-off

Digital signature sign-offs for FDA GMP compliance audits.

Core modules

Cleanroom Sterility Log

Monitor air particulate counts, differential pressure, and surface swabs.

Titer & Efficacy Tracker

Analyze post-vaccine immune response and log breakthrough infections.

Vaccine Lot Registry

Full chain-of-custody tracking from pharmaceutical lab to clinic.