LoRaWAN Implementation in Pharmaceutical GxP Environments

A Practical Guide for Quality & Compliance Professionals

LoRaWAN Implementation in Pharmaceutical GxP Environments

Table of Contents

The Digital Transformation of Pharma
Chapter 01
The Digital Transformation of Pharma
LoRaWAN Demystified
Chapter 02
LoRaWAN Demystified
GxP Regulatory Framework for Electronic Systems
Chapter 03
GxP Regulatory Framework for Electronic Systems
Building the Business Case for LoRaWAN
Chapter 04
Building the Business Case for LoRaWAN
Risk Assessment for LoRaWAN Systems
Chapter 05
Risk Assessment for LoRaWAN Systems
Supplier Assessment & Vendor Qualification
Chapter 06
Supplier Assessment & Vendor Qualification
Validation Strategy for LoRaWAN Systems
Chapter 07
Validation Strategy for LoRaWAN Systems
Installation Qualification (IQ)
Chapter 08
Installation Qualification (IQ)
Operational Qualification (OQ)
Chapter 09
Operational Qualification (OQ)
Performance Qualification (PQ)
Chapter 10
Performance Qualification (PQ)
Data Integrity in LoRaWAN Systems
Chapter 11
Data Integrity in LoRaWAN Systems
Cybersecurity in Validated LoRaWAN Environments
Chapter 12
Cybersecurity in Validated LoRaWAN Environments
Chapter 13: Change Control & Configuration Management
Chapter 13
Chapter 13: Change Control & Configuration Management
Chapter 14: Ongoing Monitoring & Compliance
Chapter 14
Chapter 14: Ongoing Monitoring & Compliance
Chapter 15: Cold Chain & GDP Applications
Chapter 15
Chapter 15: Cold Chain & GDP Applications
Chapter 16: Advanced Use Cases & Emerging Technologies
Chapter 16
Chapter 16: Advanced Use Cases & Emerging Technologies
Chapter 17: Preparing for Regulatory Inspections
Chapter 17
Chapter 17: Preparing for Regulatory Inspections
Chapter 18: Implementation Roadmap & Maturity Model
Chapter 18
Chapter 18: Implementation Roadmap & Maturity Model

About the Author

Rodrigo Klein

Written by the founder of T2 Software, a specialist in pharmaceutical digitalization since 2005. After leading digitalization initiatives across Brazil — including the development of the NEOSENSOR IoT platform — the author brings hands-on experience designing LoRaWAN-based IoT monitoring solutions for GxP facilities. This book distills that implementation experience into a practical, inspection-ready reference.

/in/rodrigoklein@eurodrigoklein@rodrigoklein