PharmaLogic — EU GDP Pharmaceutical Logistics Platform

Live Demo Environment

A fully functional prototype is running at pharma.unygms.com. All modules accessible — inventory, cold chain, QMS, serialization, reporting, barcode PWA.

URL: https://pharma.unygms.com · Credentials: ugur.yardimci@unygms.com

Open Demo

Database Tables

Microservices

Modules

Integrations

10yr

Audit Log

99.5%

Uptime SLA

Functional Modules

Each module maps directly to EU GDP and Hungarian regulatory obligations.

Inventory & Warehouse

Full batch/lot tracking with FEFO-enforced picking, multi-zone support, and strategic stock monitoring.

FEFO dispatch enforcement
Released / Quarantine / Rejected / Returned zones
Ambient, 2–8°C, −20°C, −70°C storage locations
Strategic stock for 313 NNGYK substances (Decree 16/2024)
GRN with supplier and temp at receipt
Short-dated stock alerts (configurable threshold)

Serialization & FMD / NMVS

GS1 DataMatrix pipeline with live NMVS verification and EPCIS 2.0 event generation.

GS1 DataMatrix: GTIN, Serial, Batch, Expiry (AI 01/21/10/17)
Real-time NMVS API verification before dispatch
FMD decommissioning at point of supply
Suspect pack: flag → quarantine → notify → report
EPCIS 2.0 events: commission, ship, receive, decommission
EMVO EU Hub connectivity for MAH clients

Cold Chain Monitoring

24/7 IoT sensor monitoring via MQTT, configurable breach alerts, and calibration tracking.

Continuous real-time dashboard per zone
MQTT IoT sensor integration (ELPRO, Sensitech, custom)
Configurable alarm thresholds — email / SMS / in-app
Automatic excursion record + deviation creation
Temperature logger import per shipment (CSV / API)
Sensor calibration records with recalibration alerts

Quality Management (QMS)

Deviation management, CAPA workflows, SOP control, training records, and supplier qualification.

Deviation records: Critical / Major / Minor
CAPA: root cause → corrective → preventive → effectiveness
SOP repository with version control and approval workflow
Staff training with role-based requirements and renewal alerts
Supplier & customer qualification register
Electronic signatures for critical actions (GMP Annex 11)

Transport & Recall

Shipment management, carrier GDP qualification, batch recall with customer trace and mock drill support.

Shipment creation linked to dispatch orders
GPS fleet tracking API integration
Carrier GDP certificate and qualification tracking
Batch recall: Class I / II / III with auto customer trace
Auto-generate recall notification list and templates
Mock recall simulation (no real actions triggered)

Audit Trail & Access Control

GMP Annex 11 compliant immutable audit log, RBAC, TOTP 2FA, and 10-year retention.

Tamper-evident log: who, what, old/new value, timestamp
Read-only — no deletion by any role including admin
RBAC: Admin, Responsible Person, QA, Warehouse, Read-Only
TOTP 2FA mandatory for Admin and RP roles
Individual accounts — no shared logins (GMP Annex 11)
90-day password rotation, session timeout at 15 min

Reporting & Dashboards

GDP compliance dashboard, strategic stock reports, temperature excursions, batch traceability — PDF and CSV.

GDP dashboard: open deviations, CAPAs, training gaps
Strategic stock report (Decree 16/2024): stock vs. obligation
Temperature excursion frequency and duration report
Serialization activity: scans, verifications, decommissions
Full batch traceability report (receipt → delivery)
Grafana operational dashboards (Prometheus metrics)

Barcode Terminal PWA

Offline-capable Progressive Web App for warehouse scanning with ZXing camera integration and background sync.

Works on any Android/iOS browser — no app install
ZXing DataMatrix and 1D barcode via camera
Offline-first: queued locally, synced on reconnect
Real-time NMVS verification at scan point
GRN receiving, pick list execution, dispatch confirmation

Regulatory Compliance

Designed from the ground up for EU and Hungarian pharmaceutical distribution law.

Regulation	Scope	Coverage	Priority
EU GDP Guidelines 2013/C 343/01	All wholesale distributors	Quality system, temperature control, 10-year audit trail	MUST
FMD / EU 2016/161	Prescription medicines	DataMatrix scanning, EMVS verification, decommissioning, EPCIS	MUST
GMP Annex 11	All computerised systems	Tamper-evident audit, electronic signatures, individual accounts	MUST
ALCOA+ Data Integrity	All records	Attributable, Legible, Contemporaneous, Original, Accurate	MUST
Hungarian Act XCV of 2005	All medicinal products	National licensing and distribution compliance	HU MUST
Government Decree 44/2004	Wholesale distributors	GDP implementation, Responsible Person role, OGYÉI inspection	HU MUST
Decree 16/2024 (MoI)	313 strategic substances	Rolling 12-month buffer stock monitoring, NNGYK compliance report	HU MUST
GAMP5 Category 4/5	Validated systems	IQ/OQ/PQ documentation support, change control	SHOULD
EU MDR 2017/745	Medical devices	UDI tracking, EUDAMED event support	SHOULD

Architecture

Microservices on Docker Compose with optional HA overlay.

┌───────────────────────────────────────────────────────────┐
│               NGINX Reverse Proxy                        │
│     pharma.unygms.com  ·  TLS 1.3  ·  Rate limiting      │
└──────┬──────────┬──────────────┬────────────┬─────────────┘
       │          │              │            │
  / (frontend) /api/v1/  /terminal/  /coldmonitor/
       │          │              │            │
  ┌────▼────┐ ┌───▼──────┐ ┌────▼─────┐ ┌───▼──────────┐
  │ React 18│ │  FastAPI │ │  FastAPI  │ │   FastAPI   │
  │ Admin UI│ │ Core:8000│ │ Term:8001│ │  Cold:8002   │
  └─────────┘ └────┬─────┘ └────┬─────┘ └──────┬───────┘
                   │             │               │ MQTT
             ┌─────▼─────────────▼───────────────▼──────┐
             │       PostgreSQL 15  ·  Redis 7         │
             │     pharmalogic DB    Celery + Cache      │
             └───────────────────────────────────────────┘
                   │ Celery              │ MQTT broker
             ┌─────▼────────┐    ┌───────▼────────┐
             │  Celery      │    │  Mosquitto 2  │
             │ Worker + Beat│    │  IoT sensors   │
             └─────┬────────┘    └────────────────┘
                   │
             ┌─────▼──────────────────────────┐
             │  Prometheus  ·  Grafana       │
             └────────────────────────────────┘

BackendFastAPI 0.115 · Python 3.12

FrontendReact 18.3 · React Router 6

DatabasePostgreSQL 15 · SQLAlchemy 2.0

Cache / QueueRedis 7 · Celery 5.4

MQTTMosquitto 2 · aiomqtt

AuthJWT · RBAC · PyOTP (2FA)

BarcodeZXing · GS1 DataMatrix

MonitoringPrometheus · Grafana

DeploymentDocker Compose · Nginx

HA ModeMulti-node compose overlay

Integrations

Open API design for connecting to existing ERP, regulatory, and IoT systems.

Hungarian NMVS

REST API

FMD pack verification and decommissioning against the OGYÉI/NNGYK national endpoint.

EMVO EU Hub

SOAP/REST · EPCIS 2.0

MAH serialization event upload to the European Medicines Verification Organisation hub.

IoT Temperature Sensors

MQTT · REST · CSV Import

Real-time cold chain — compatible with ELPRO, Sensitech, and custom MQTT devices.

GPS Fleet Tracking

REST API

Vehicle and shipment tracking via fleet management system API.

SAP ERP

REST API · CSV

Order and invoice synchronization with SAP S/4HANA and SAP ATTP.

Oracle ERP

REST API

Bi-directional sync with Oracle SCM Cloud for purchase orders and inventory.

Hospital Procurement (HU)

REST API · EDI

Hungarian centralized hospital procurement platform (mandatory from Jan 2025).

GS1 EPCIS Repository

EPCIS 2.0 JSON-LD / XML

Supply chain events in GS1 EPCIS 2.0 format for full interoperability.

Email / SMS Gateway

SMTP · SMS API

Alerts, temperature breach notifications, and recall communications.

Try PharmaLogic

A live demo is running now. Contact us to explore all modules.

Open Live Demo Request Access Back to UNYGMS

EU GDP + FMD compliantpharmaceutical logistics.

Live Demo Environment

Try PharmaLogic

EU GDP + FMD compliant
pharmaceutical logistics.