Pharmaceutical industry & accredited laboratories
GxP-compliant environmental monitoring, IQ/OQ/PQ kit included, native ALCOA+ audit trail. Your data kept 100% in Switzerland — on Swiss infrastructure, outside any foreign jurisdiction.
Compliance that leaves no room for approximation
Your Swissmedic audits leave nothing to chance.
An incomplete audit trail, missing signatures, potentially editable data: no validation, no marketing authorisation. Many consumer-grade monitoring systems do not hold up to a rigorous audit.
A foreign cloud puts your data sovereignty at risk.
If your production data passes through a cloud outside Switzerland (American, European or Asian), clients who require strict data sovereignty can legitimately ask you to change. Better to be ahead than to react.
A platform built for regulated environments
Native compliance, ready-made documentation, fully Swiss infrastructure — with no dependency on a foreign cloud.
IQ/OQ/PQ kit provided
Complete validation documentation (Installation, Operational, Performance) ready for your Swissmedic audits. Initial package included for deployments up to 20 sensors.
Native ALCOA+ audit trail
Every measurement is traced, timestamped in real time, immutable, accessible and complete. The platform natively complies with the ALCOA+ principles required in regulated environments.
21 CFR Part 11 / EU Annex 11
Compliance with FDA rules (United States) and EU GMP for electronic records: access controls, signatures, verifiable audit trail.
Clear update policy
Scheduled half-yearly updates with a client-signed OQ (operational qualification) review. In the event of a security flaw or zero-day, an immediate patch is applied with an expedited OQ. Your initial IQ remains valid — no full revalidation with every update.
The interface, at a glance
A consolidated view of all your critical points — cleanrooms (differential pressure), stability chambers, raw-material refrigerators, finished-product cold chain. Complete audit trail for your Swissmedic validations.
| Name | Type | Status |
|---|---|---|
| Cleanroom A | DP | Out of range |
| Cleanroom B | DP | Active |
| Stab. chamber 25 °C | THP | Active |
| RM fridge 01 (2-8 °C) | THP | Active |
| RM fridge 02 (2-8 °C) | THP | Active |
| FP storage | THP | Active |
| Time | Sensor | Type | Severity |
|---|---|---|---|
| 10:14 | Cleanroom A | ΔP < 8 Pa (threshold) | Critical |
| Date | Sensor | Type | Severity | Duration | Escalation | Status |
|---|---|---|---|---|---|---|
| 28/05 · 10:14 | Cleanroom A | ΔP < 8 Pa | Critical | 7 min | Active | |
| 27/05 · 14:48 | Stab. chamber 25 °C | RH > 65 % | Warning | 12 min | Resolved | |
| 26/05 · 03:22 | RM fridge 02 (2-8 °C) | Temperature > 8 °C | Critical | 9 min | Resolved | |
| 25/05 · 19:11 | FP storage | Sensor offline | Info | 3 min | Resolved | |
| 24/05 · 08:54 | Cleanroom B | ΔP > 30 Pa | Warning | 5 min | Resolved |
| Created | Name | Type | Format | ||
|---|---|---|---|---|---|
| 2026-05-20 14:32:11 | Swissmedic — IQ/OQ/PQ | Report | |||
| 2026-05-18 09:14:25 | Swiss Pharmacopoeia | Report | |||
| 2026-05-12 16:42:08 | GAMP 5 — Category 4 | Report | |||
| 2026-04-28 15:29:39 | 21 CFR Part 11 — Audit trail | Sub-report | |||
| 2026-04-28 10:35:10 | ISO/IEC 17025 — Calibration | Sub-report | |||
| 2026-04-15 08:12:45 | Custom report | Report |
Interactive preview — 4 explorable views. Sample data for demonstration purposes.
Typical configuration for a pharmaceutical production site
A representative example to give you a sense of scale. Precise sizing is done together with you, on site.
The context
Pharmaceutical production site with a central pharmacy, GMP-controlled production areas, analytical laboratories, cold rooms for raw materials and finished products. Regular Swissmedic audits, EU GMP requirements for export.
The typical deployment
50 sensors deployed across the whole perimeter — medicine refrigerators, production areas, laboratories, cold rooms. 10 gateways to cover the different zones of the site. Initial IQ/OQ/PQ qualification package.
The outcome
Complete ALCOA+ audit trail for every Swissmedic audit. Up-to-date IQ/OQ/PQ documentation. Scheduled half-yearly updates with a signed OQ review — the platform stays auditable at all times, with no additional effort on your part.
Compliant with the strictest requirements
The standards the platform covers natively for regulated pharmaceutical environments.
Good Manufacturing, Laboratory and Clinical Practices. IQ/OQ/PQ qualification kit provided with your deployment.
US FDA rules for electronic records and signatures. Included in the Pharma subscription.
European GMP for computerised systems. Included in the Pharma subscription.
Validation of computerised systems according to category 4 (configurable). Documentation ready for your audits.
Data integrity principles: traced, timestamped, immutable, complete, accessible. Natively enforced by the platform.
Storage ranges of 2-8 °C and 15-25 °C required for medicines in Switzerland. Pre-set configuration and alerts.
Accredited calibration via an SCS-accredited laboratory. Evidentiary value of measurements for your internal and external audits.
Data kept 100% in Switzerland, on our infrastructure in Crissier (VD). No dependency on a foreign cloud.
Six steps to move forward together
From the first demo to ongoing operations — a clear path to build a long-term partnership.