Computer System Validation Books

Data Integrity in Computerized Systems: Data Integrity and GxP

Data Integrity in Computerized Systems: Data Integrity and GxP

Discover the essential guide for professionals working in regulated industries! “Data Integrity in Computerized Systems” offers a clear and practical approach to achieving compliance with GxP requirements, focusing on how to build, validate, and maintain trustworthy computerized systems. This book is perfect for QA specialists, CSV professionals, auditors, and anyone responsible for data integrity in the life sciences or other GxP-bound sectors.

  • Understand the ALCOA+ principles and regulatory expectations
  • Learn how to manage data lifecycle and mitigate integrity risks
  • Get real-world examples from pharma and biotech environments
  • Suitable for both beginners and experienced practitioners

Don't miss your chance to strengthen your compliance and data governance strategy. 👉 Order your copy now on Amazon!


Software Development for GxP Regulated Industries: Deliver GxP Compliance Software in an Agile Way

Software Development for GxP Regulated Industries: Deliver GxP Compliance Software in an Agile Way

Bridging the gap between modern software development and strict regulatory requirements, “Software Development for GxP Regulated Industries” is a must-read for developers, project managers, and QA professionals working in life sciences and other regulated sectors. This practical guide shows how to implement Agile methodologies while maintaining full GxP compliance throughout the software lifecycle.

  • Learn how to deliver validated software in iterative cycles
  • Understand risk-based validation and documentation strategies
  • Align Agile, DevOps, and GAMP® 5 guidelines effectively
  • Real-world examples, templates, and best practices included

Whether you're modernizing legacy systems or starting a new project from scratch, this book is your roadmap to fast, compliant, and efficient software delivery. 👉 Grab your copy today on Amazon!

Software Development Manager Guide: People, Process, Tools, Delivery

Software Development Manager Guide: People, Process, Tools, Delivery

Ready to lead your software team with confidence and clarity? “Software Development Manager Guide” is the ultimate handbook for tech leads, engineering managers, and aspiring CTOs who want to master the four pillars of successful software leadership: people, process, tools, and delivery.

  • Learn how to build, grow, and motivate high-performing teams
  • Implement effective development processes without unnecessary bureaucracy
  • Choose the right tools for collaboration, quality, and automation
  • Deliver software that meets business goals on time and with quality

Whether you're stepping into your first leadership role or refining your current approach, this book gives you actionable insights and frameworks for long-term success. 👉 Get your copy now on Amazon!