Transmission log

Compliance & cold chain, in practice

Working notes from the engineers who build Abhilekh — what the regulations actually ask for, how the arithmetic works, and where monitoring programmes go wrong. No gated PDFs.

compliance21-cfr-part-11validation

21 CFR Part 11 for temperature monitoring: a clause-by-clause checklist

No product can be sold as 'Part 11 certified' — compliance is a property of a validated system in use, not a badge on a datasheet. Here is what each clause of Part 11 actually asks of a temperature monitoring system, and how to test it before an inspector does.

8 min read
compliancemktwarehouse

Mean kinetic temperature, worked through by hand

MKT is not the average temperature, and treating it as one is how warehouses pass every monthly report and still fail a Product Quality Review. Here is the equation, a worked example you can check with a calculator, and the four mistakes that make an MKT number meaningless.

5 min read
complianceschedule-mdata-integrity

Revised Schedule M is live: what inspectors now expect from your computerised systems

The extension expired on 31 December 2025 and the DCGI has said there will be no more. Here is what the computerised-systems and data-integrity parts of Revised Schedule M actually ask of a manufacturing site — and the seven questions an inspector will put to your temperature records.

7 min read
validationtemperature-mappingwarehouse

Temperature mapping: how many sensors, where, and for how long

Mapping is the study that tells you where your permanent sensors belong. Get the sensor count, positions and duration wrong and every monitoring decision downstream inherits the error. A practical guide to designing a study that survives an audit.

8 min read
companyannouncement

Welcome to Neodrics

We're building the new generation of connected intelligence. Here's what you can expect from us.

1 min read