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Platform architecture

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
INTEGRATIONSEnterprise systemsLIMS · ERP · SCADADEPARTMENTSWho uses itQA · QC · MicroSOFTWAREControlling & monitoringAudit · RBACCONNECTIVITYAny instrument, any protocolModbus · OPC-UA

Layer 1 — Connectivity

Any instrument, any vendor

Nothing above this layer is sector-specific. The same interfaces that connect a microbial air sampler connect a flow transmitter or a plant-floor controller — which is why the platform moves between pharmaceutical, industrial and automotive work without being rebuilt.

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

IoT & Industry 4.0

For plants moving to a unified data layer.

OPC-UA MQTT Bluetooth

On-device sensing

What our own instruments measure and identify at the point of use.

Agar plate detection Mass flow QR / barcode Pressure Temperature Humidity Leak detection Weight Direct printing

Software & API

For instruments and systems that expose an interface of their own.

REST API Custom protocol File-based Webhook

Layer 2 — Controlling & monitoring software

Where the record becomes defensible

The part an auditor actually opens. Every feature below exists because a real inspection question needed answering.

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.

Automatic trend reports

Six-month trend reports generated on their own, across every instrument and every site. Inspection-ready without manual compilation.

Calibration tracker

Alerts before expiry and locks the instrument out on lapse, with the full IQ / OQ / PQ history retained for each unit.

Backup & restore

Twice-daily automated server backup with a hash-verified integrity check, and one-click restore to any point in time.

Bidirectional data transfer

Configuration and recipes go software → instrument; results and audit records come instrument → software. Fully automated, no manual sync.

Online device monitoring & control

Live instrument status from any networked device, remote start and stop, and live result streaming to a multi-device dashboard.

Digital, paperless workflow

Electronic batch records and fully digital approvals, with e-signatures carrying a mandatory reason and comment.

Layer 3 — Departments

Who works in it

One platform, with each department seeing the part of it they are accountable for.

QAAudit · CAPA · SOPs · deviation management
QCTesting · batch release · method validation
MicrobiologyEnvironmental monitoring · air sampling
IT / CSVValidation · data integrity · security
ProductionManufacturing · GMP compliance
EngineeringCalibration · preventive maintenance
RegulatorySubmissions · inspections · audits

Layer 4 — Integrations

What it feeds

Monitoring data is only useful where the rest of the business already works. These are the handoffs.

LIMS / MODADirect API plus encrypted file push
ERP / QMS / MESBi-directional enterprise sync
EMS / FMSEnvironmental and facility management
OPC-UA serverSCADA · DCS · Industry 4.0
MQTT brokerCloud · IoT · edge analytics
REST APIThird-party and custom applications
WebhookEvent-driven notifications

Model tiering

One design, three commercial tiers

Any product we develop can ship at three levels of record keeping. The instrument does not change; what it does with the result does.

01

Core

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

02

Memory

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

03

CFR

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

Designed against

Regulatory frameworks

Design inputs, not a claims list. Each one shapes something concrete in the schema, the login flow or the time source.

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

Want this behind your instrument?

The platform is available for OEM integration. If you manufacture instruments and need this capability inside your own product, that is a conversation worth having.

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