How to build GxP-compliant software in an agile way - how to develop software product for life science

In the world of pharmaceuticals, clinical trials, and life sciences, developing software isn’t just about writing clean code or deploying features quickly. It’s about compliance—with EU Annex 11, FDA 21 CFR Part 11, and a web of regulations that make or break your product’s viability.

But here’s the catch: traditional validation methods (like the V-model) are too slow, rigid, and expensive for today’s agile-driven teams.

That’s where Adrian Krześniak’s “Software Development for GxP Regulated Industries” enters the scene—a short, sharp, and practical book that bridges agile development with GxP validation. It’s a must-read for software vendors and in-house teams building systems for regulated environments.

Why GxP software needs special treatment

Whether you're building LIMS, eCTD tools, lab automation platforms, or clinical trial software, you're stepping into a high-stakes environment. GxP-regulated companies operate under intense scrutiny, and your software needs to comply with:

• Audit trails
• Electronic signatures
• Data integrity (ALCOA+)
• Access control and change management

These aren’t just “nice-to-have” features. They’re non-negotiable regulatory requirements, and failing to meet them can result in fines, delays, or even shutdowns.

Agile validation: Yes, it’s possible

The main value of this book? It shows you how to deliver validated software in a fast-paced, agile environment—without waiting for months between requirement gathering and user acceptance.

Krzesniak introduces a method of "embedded validation", which means:

• Validation is not an afterthought
• esting and documentation happen in sync with development
• The compliance evidence is produced iteratively
• Agile ceremonies (like sprints, standups, reviews) include validation checkpoints

This transforms validation from a burdensome waterfall task into a seamless part of your DevOps process.

What you'll learn inside the book

This isn’t a theoretical textbook. It’s a field manual packed with practical insights, including:

• How to align agile practices with regulatory expectations
• Which parts of EU Annex 11 and 21 CFR Part 11 you must address in your software
• How to implement audit trails and electronic signatures from day one
• Tips for preparing your team for a GxP supplier audit
• Best practices for maintaining validation across software updates

Whether you’re developing in-house tools or selling software to pharma clients, this guide gives you a framework to meet GxP requirements without slowing down delivery.

Who should read this book?

This guide is tailor-made for:

• Software developers in life sciences
• Product owners and agile coaches working with GxP clients
• CTOs and tech leads selling to pharma, medtech, or regulated labs
• QA/CSV professionals looking to modernize their approach
• Startup founders building tools for clinical, biotech, or digital health

Even if you’re new to the GxP world, the book’s tone is clear and practical—perfect for anyone needing to ramp up fast.

Why it's worth your time (and shelf space)

Let’s face it: most CSV and GxP literature is either outdated or written in dense regulatory jargon. This book is different:

• Short and actionable (you can read it in an afternoon)
• Real-world examples, not theory
• Written by someone who’s actually built and validated systems in GxP environments
• Focused on what matters most—agile validation that actually works

Final word: validation doesn’t have to be a bottleneck

In regulated industries, you can’t ship fast and break things. But you also can’t afford to validate software once a year. Adrian Krześniak’s “Software Development for GxP Regulated Industries” gives you the blueprint to do both: build fast, deliver value—and stay fully compliant.

👉 Buy the book on Amazon and make GxP validation an asset, not a burden.

📞 Need help with GxP software development strategy ?

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