AI-Native Enterprise Intelligence

The intelligence layer for
regulated operations

Real-time visibility into your facility. Patterns your team would miss. Answers in seconds, not days. We connect physical measurement to operational intelligence — something no monitoring company, no QMS platform, and no consulting firm currently provides together.

See it in action

The problem nobody talks about

Your sensors generate data. Your team generates paperwork. But nobody generates answers.

No intelligence from the data

Sensors measure. Dashboards display. But nothing connects what your sensors see to what your business needs to know — until something goes wrong.

No historical context

"What was the temperature in the storage area three weeks ago?" Nobody can answer without pulling logs. Your compliance team spends hours compiling what should take seconds.

No real-time visibility

Your team operates on "we think everything is okay." No live view across zones. No pattern detection. No early warning before a small drift becomes a costly problem.

Manual documentation

Deviation reports take 25–40 hours to write. Environmental data is copied manually into compliance records. Your most expensive people spend their time on paperwork instead of decisions.

What changes when you have intelligence

Every problem above disappears when your sensors connect to an intelligence layer.

✓

Live view across all zones — real-time environmental status for every room, every sensor, one dashboard

✓

Pattern detection — spot trends across days and weeks before they become costly problems

✓

Early warning — AI alerts you before a small issue becomes a costly problem, not after

✓

Instant historical context — "What happened in the storage area 3 weeks ago?" answered in seconds

✓

Compliance reports in minutes — deviation investigations, environmental monitoring reports, regulatory documentation generated automatically in the format your regulator reads

✓

Inspection readiness on demand — "Are we ready for an audit?" answered with data, not guesswork

✓

Alerts with context — AI diagnostics tell you what happened, why, and what to do next

✓

Your QP's time freed up — senior staff make decisions instead of compiling data

How the platform works

Four layers that transform raw sensor data into action, documentation, decisions, and records.

SENSORS The Right Action The Right Documentation The Right Decisions The Right Records Primathera INTELLIGENCE LAYER

The Right Decisions

A conversational AI that answers operational questions in seconds. Operational status across all zones. Risk assessments in real time. 30-day compliance summary. "What was the humidity spike in Zone B last Tuesday?" — answered instantly, not after hours of log-pulling.

The Right Action

Intelligent alerts routed to the right person, via the right channel, at the right moment. AI-written diagnostics that tell you what happened, why it matters, and what to do next — not just "threshold exceeded."

The Right Records

Sensors and operational systems connected. Data flows automatically to your ERP, QMS, and WMS — no manual entry, no transcription errors, no reconciliation gaps.

The Right Documentation

Compliance records auto-generated in the exact format each regulator expects. Your team reviews and approves — not writes from scratch. Hours of manual work, done in minutes.

Sensor-agnostic by design

We sit on top of the sensors you already have. No rip-and-replace, no proprietary hardware lock-in. Connect your existing infrastructure and start generating intelligence immediately.

What we do better than anyone

No monitoring company, QMS platform, or consulting firm provides all four layers together.

01

AI-Powered Operational Intelligence

A conversational interface that answers questions about your operations in seconds, not hours. Zone status, risk assessments, compliance summaries, inspection readiness — intelligence that usually requires hours of senior staff time, delivered instantly. Quick-action buttons tailored to your industry. Free-text questions for anything else. "What was the temperature alert in the dry room 2 months ago?" — the AI connects what your sensors measure to what your business needs to know.

02

Intelligent Alert Routing

Routes by role, urgency, channel, time of day, with automatic escalation. Every alert includes AI-written diagnostic context — what happened, what's at risk, and how long you have to act. Supports WhatsApp, LINE, Telegram, Slack, email, and push notifications. Not threshold noise — actionable intelligence delivered to the person who can act.

03

Operational Automation & System Integration

Sensor data and operational records flow directly into your ERP, QMS, and WMS. Manual data entry is replaced with sensor-verified records. Discrepancy detection identifies gaps between physical reality and what your systems show. Connecting your operational data to your financial systems unlocks intelligence across your entire business.

04

AI-Generated Compliance Documentation

When an excursion is detected, all context is assembled automatically. A formal deviation investigation is generated in the format your regulator reads — MHRA, EU-GMP, GACP, CQC, RCVS, FDA. Your qualified person reviews and approves — not writes from scratch. ALCOA+ compliant with an immutable audit trail. What takes compliance teams 25–40 hours is done in minutes.

Technology Partners
Google Cloud Twilio WhatsApp LINE Telegram Slack
Compliance Frameworks
ALCOA+ EU-GMP GDP GACP 21 CFR Part 11

Solutions & Services

From self-serve monitoring to enterprise intelligence — we meet you where you are.

SaaS Monitoring & Intelligence

Connect your existing sensors. Get intelligent alerts, automated compliance documentation, and an AI assistant that knows your facility. Self-serve onboarding — start generating intelligence in days, not months.

IoT Consulting & Deployment

We design, configure, and deploy monitoring infrastructure tailored to your regulatory environment. Sensor selection, placement strategy, threshold configuration, and integration with your systems of record.

Enterprise Intelligence

Cross-site operational and financial intelligence for multi-location businesses. Connect compliance data to your P&L. Benchmark locations. Compliance intelligence across your operations and content — regulatory monitoring that goes beyond environmental data. Answer the questions your current systems can't — which site, which team, which process is driving cost, risk, or underperformance.

Advisory

Ongoing strategic advisory for regulated operations. Operational excellence, compliance readiness, technology strategy. We help leadership teams connect compliance data to financial performance — linking what your sensors measure to what your P&L shows. ERP and financial system integration advisory for organisations ready to turn operational intelligence into boardroom-level decisions. For leadership teams that want a trusted partner, not just a platform.

How we work with you

From a one-time diagnostic to a long-term intelligence partnership — we meet you where you are.

ASSESS

Operational Intelligence Audit

A structured diagnostic of your monitoring infrastructure, compliance exposure, and decision visibility gaps. You get a prioritised roadmap — what to fix, what to automate, and where intelligence is missing. The starting point for organisations that know something isn't working but can't pinpoint where.

OPERATE

Continuous Intelligence

Ongoing monitoring, AI-generated compliance documentation, and a decision intelligence layer connected to your operations. Your leadership team gets structured visibility into performance, compliance, and risk — not dashboards, but answers. The platform runs continuously; the advisory ensures it drives the right outcomes.

TRANSFORM

Enterprise Transformation

Full integration with your ERP, QMS, and financial systems. Sensor-verified records replace manual data entry. Operational data connects to your P&L. For multi-location organisations ready to move from reactive compliance to connected operational intelligence across every site.

BUILD

IoT Infrastructure

We design, configure, and deploy monitoring infrastructure tailored to your regulatory environment. Sensor selection, placement strategy, threshold configuration, and integration with your systems of record. For organisations that need the physical layer built before the intelligence layer can begin.

Built for industries where compliance is non-negotiable

Primathera works across regulated environments where environmental monitoring, calibrated sensor records, and audit-ready compliance documentation are not optional — they're operational requirements. If your industry is regulated, your sensors generate data, and your team spends hours on compliance paperwork — we should talk.

Environmental monitoring Cold chain compliance Temperature & humidity tracking CO₂ & differential pressure Regulatory documentation Cross-site intelligence ERP / QMS integration Discrepancy detection
Tell us about your environment
Pharmaceutical

Your RP gets inspection readiness
in 10 seconds, not 2 hours

Deviation reports take hours to write manually. Shift handovers are verbal. Inspection preparation is stressful. Product-at-risk assessments are reactive. Primathera changes all of this.

Cold-chain compliance monitoring

Intelligent Alert Routing

AI-written alerts that tell your RP exactly what's at risk and how long they have to act — not just "temperature exceeded threshold."

Automated Deviation Reports

MHRA GDP deviation investigations generated automatically from sensor data. Your RP reviews and signs — not writes from scratch.

Instant Inspection Readiness

"Are we inspection-ready?" answered in seconds. Open CAPAs, calibration status, recent excursions — one question, one answer.

Automated Quarantine

Temperature excursion detected — product quarantine status updated in your WMS automatically. No manual flagging, no missed products.

GDP 21 CFR Part 11 EU GMP Annex 11 EU GMP Annex 15 ALCOA+
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Trust & Compliance

Built for regulated environments where data integrity, auditability, and security are non-negotiable.

ALCOA+ Data Integrity

All data is attributable, legible, contemporaneous, original, and accurate. Every record includes full provenance and an immutable, tamper-evident audit trail.

Calibration-Grade Accuracy

Audit-ready calibration certificates linked to every sensor reading — calibration record, calibration date, and the accredited laboratory that performed it. Not marketing claims — documented traceability.

Regulatory Frameworks

Documentation generated in the format each regulator expects: EU-GMP (Annex 11, Annex 15), GDP, GACP, 21 CFR Part 11, MHRA, RCVS PSS, CQC, Thai FDA, TGA Good Wholesaling Practice.

Validation & Security

IQ/OQ/PQ validation methodology, GAMP5 alignment. Encryption at rest and in transit. Regional data residency options. Enterprise cloud infrastructure with industry-standard security controls.

Pricing tailored to your environment

Every regulated environment is different — different scale, different regulatory requirements, different systems of record. Our pricing reflects your operation, not a one-size-fits-all tier. From single-site SaaS monitoring to multi-location enterprise intelligence, we build a plan that fits.

ALCOA+ audit trail Calibration certificate storage Multi-channel intelligent alerts AI assistant Sensor-agnostic connectivity
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QIs there a setup fee?
A

Depends on your deployment. SaaS monitoring has no setup fee. Consulting and enterprise solutions include onboarding and configuration.

QDo I need to buy hardware?
A

We're sensor-agnostic. If you already have sensors, we connect to them. If you need sensors, we advise on the right solution for your environment.

QHow long does onboarding take?
A

SaaS monitoring can be live in days. Enterprise deployments with system integration typically take 2–4 weeks.

PRIMATHERA GROUP

Every regulated environment generates data nobody acts on. We turn that data into the four things that determine whether a facility passes its next inspection, protects its products, and runs profitably — the right action, the right documentation, the right decisions, and the right records.

We work with regulated businesses across multiple industries and geographies. Our platform is built by people who understand both the technology and the regulatory reality.

See how Primathera works for your environment

A 15-minute live demo tailored to your specific environment and regulatory requirements.

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Prefer email? info@primatheragroup.com