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Neutron Technologies

Presence · Pharmaceutical

Instruments whose data
survives an audit

Microbial air samplers and the compliance software behind them, installed across Indian pharmaceutical sites. Built against 21 CFR Part 11 and EU GMP Annex 11 from the first line of code, not fitted with them afterwards.

21 CFR Part 11 EU GMP Annex 11 LIMS / MODA ALCOA+
Pharmaceutical workTalk to engineering
01 / 05

Product development

We design the product, and everything that makes it work

Mechanical design, PCB and electronics, firmware, touchscreen software and the server application behind it — under one roof, in one team. That is why an instrument we build can be traced from a QA signature all the way back to the sensor that produced the reading.

Solutions that drive transformation across multiple industries, starting with pharmaceuticals. Design and development runs out of Maharashtra, Gujarat and Telangana.

Model tiering

Any product, three commercial tiers

The same instrument can ship at three levels of record keeping. This is how a single design covers a wide range of budgets and obligations.

Core

The instrument on its own. An operator sets a run and reads the result. No electronic records.

Memory

Partial CFR. User login, on-board record storage and an on-device audit trail, with records exported from the instrument.

CFR

Networked. Records land on the server as they are taken, with a server-side immutable audit trail and synchronised timestamps.

Sectors

Three industries, one engineering team

The disciplines transfer. A compliant audit trail and a plant-floor data logger are the same problem wearing different clothes — capture it accurately, hold it safely, hand it on cleanly.

Pharmaceutical

Instruments whose data survives an audit

Our longest-running sector and where the platform was hardened. We design microbial air sampling instruments and the server software that holds their records — user management, immutable audit trail, electronic signature and review workflow, built against 21 CFR Part 11 and EU GMP Annex 11 rather than retro-fitted to them. LIMS and MODA integration is standard, not a project.

21 CFR Part 11 EU GMP Annex 11 EU GMP Annex 1 ALCOA+ USP <1116>

Shipping · installed across Indian pharmaceutical sites

Automotive

CAN-based products for the aftermarket

We build customised CAN-protocol products for the automotive aftermarket segment, and take on tailored OEM work where a client needs a specific module designed rather than sourced. The work spans video interfacing between cameras and head units, vehicle bus integration, and the per-vehicle configuration that makes an aftermarket part behave like a factory one.

CAN / CAN-FD LIN Serialiser / deserialiser links LVDS AHD / CVBS

Active development · aftermarket and OEM engagements

Industrial automation

Bespoke instruments for the plant floor

Data loggers, HMI panels and the software behind them, designed for a specific process rather than bought off a shelf and bent to fit. The same connectivity layer that carries a pharmaceutical instrument carries a plant-floor one — Modbus, analog and digital I/O, OPC-UA and MQTT are in the platform already.

Modbus RTU / TCP / ASCII RS-232 / RS-485 4–20 mA 0–10 V OPC-UA

Active development · bespoke and retrofit projects

Sector detail

Neutron Platform

Any instrument · Any protocol · Any interface — one platform

A server-based platform that connects instruments of any vendor over any interface, holds their records, and hands them to the systems the rest of the business already runs on.

GAMP 5 Category 4 Multi-instrument Multi-site Multi-protocol

Network

Site network, with synchronised time and encryption in transit.

Wi-Fi Ethernet NTP sync SSL / TLS

Serial & fieldbus

The interfaces most plant and lab instruments already speak.

RS-232 RS-485 USB Modbus ASCII Modbus RTU Modbus TCP

Analog I/O

Direct sensor and transmitter signals, no gateway in between.

0–20 mA 4–20 mA 0–5 V 0–10 V

Digital I/O

Interlocks, alarms and control lines.

DI · 24 V DC DI · TTL DI · dry contact DO · relay DO · open collector DO · 24 V DC
Full architecture

Compliance software

Designed against the regulation, not around it

These frameworks are design inputs. They shape the database schema, the login flow and the time source — not just the documentation pack at the end.

Six-dimension audit trail

Who, when, what, where, the value before and the value after — with the reason recorded. Held server-side and immutable: no administrator account can delete an entry.

Full ALCOA+

Attributable, legible, contemporaneous, original, accurate, complete, consistent, and enduring & available. All eight dimensions, designed in rather than argued for.

Role-based permission groups

Analyst, supervisor, QA manager and administrator, with department-wise permissions. Access is granted by role, not by sharing a password.

Multilevel electronic authorisation

Analyst → supervisor → QA manager → department head. Each level electronically signed and time-stamped, with a mandatory reason field.

LDAP / Active Directory login

One corporate login across every instrument, with automatic session lockout. No separate instrument credentials to manage or share.

Alert & action limit detection

A limit breach is flagged the moment it happens and raises a deviation record carrying the timestamp, user, location and result.

21 CFR Part 11 EU Annex 11 EU GMP Annex 1 (2022) Schedule M 2023 ALCOA+ USP <1116> EN ISO 14698 WHO TRS 996 PIC/S PI 041 MHRA GxP DI ICH Q9 / Q10 GAMP 5 Cat. 4

Patents & IP

Two filings, both on the same weak point

India · 202321074566 Filed — under examination

Smart Air Sampling System and Method

A sampling system in which the aspirating head communicates with the instrument wirelessly, so the head can be identified, tracked and validated as part of the sampling record rather than treated as an anonymous accessory.

India · 202421076066 Filed — under examination

Real-Time Agar Plate and Sampling Head Closure Detection Mechanism for Microbial Air Sampler

Sensing that tells the instrument, in real time, whether an agar plate is actually present and whether the sampling head is properly closed before and during a run.

Read the IP position

Engagement

Documented from the first review

The sequence matters, so it is numbered. Each stage produces documents the next one depends on.

  1. 01

    Requirement & design

    URS review, design specification, risk assessment and a traceability matrix that survives an audit.

  2. 02

    Build & verification

    Prototype, design verification testing, EMC and safety pre-compliance, and pilot production.

  3. 03

    Qualification

    IQ, OQ and PQ protocols and execution, with factory and on-site calibration certificates.

  4. 04

    Support & change control

    Release notes, version control, CAPA handling, AMC/CMC contracts and recalibration.

Technical insights

Making an instrument audit-ready

How to make an instrument audit-ready — attribution, audit trails, signatures and integration. Written by the engineers who had to make it pass an inspection.

All 13 articles
Architecture

One compliance architecture, any instrument

Most instruments in a regulated facility face the same problem: the measurement is fine, the record around it is not. That problem is not specific to any one instrument, and neither is the solution.

4 min read Architecture

One design, three compliance tiers: matching record-keeping to obligation

Full 21 CFR Part 11 capability on an instrument that does not need it is money spent on a finding you were never going to get. The tier should be chosen by obligation, not by budget.

3 min read Data integrity

What 21 CFR Part 11 and EU Annex 11 actually require

Both regulations are short, readable and widely misquoted. Most of what gets sold as compliance is a login screen and a log file, which is neither of the things the text asks for.

3 min read

Have a product that needs building?

Bring us a requirement document, a rough sketch, or a problem your current instrument will not solve. We will tell you honestly whether it is something we should take on.

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