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Welcome to This Blog Has Integrity
In a world where artificial intelligence, computerized systems, and regulations evolve rapidly, data reliability and completeness have become the foundation o...
Galit Lisaey/
This Blog Has Integrity
Professional insights, best practices, and regulatory updates in Data Integrity and Computerized System Validation (CSV).
The posts and articles reflect practical perspectives inspired by the CPF approach, integrating quality, compliance, and innovation.
How Do You Measure Integrity?
About eight years ago, I was asked a question that has stayed with me ever since. And today, in a completely different context, I found myself returning to tha...
Galit Lisaey/
#5 Who's afraid of Annex 11?
Annex 11 – Part 5 Or in other words: Another episode in the series "Who’s Afraid of Annex 11?" This time, we dive into one of the hottest topics among my collea...
Galit Lisaey/
#4 Who's afraid of Annex 11?
Annex 11 – Part 4 Or in other words: Another episode in the series "Who’s Afraid of Annex 11?" This time we focus on one of my favorite and most formative parag...
Galit Lisaey/
#3 Who's afraid of Annex 11?
🧭 Risk Management in Computerized Systems – A Core Principle of Annex 11 Quality control in computerized systems requires a structured, risk-based approach. T...
Galit Lisaey/
#2 Who's afraid of Annex 11?
The Annex 11 document defines the #GMP requirements for computerized systems and forms part of the European quality-management regulations for the pharmaceuti...
Galit Lisaey/
#1 Who's afraid of Annex 11?
Who’s Afraid of Annex 11? Part One This series will explore the subtopics related to the requirements set by the EMA – the European Medicines Agency , which is...
Galit Lisaey/
What Do Hieroglyphs Have to Do with Data Integrity
Five years ago, I wrote a post about my son – back then, a young superhero fan deeply immersed in Rick Riordan’s books. He’s grown since then, but one thing ha...
Galit Lisaey/
The Dialogue That’s Missing from Every SOP
This time, I want to talk about one of the most powerful tools we have – and the one you’ll never find in any procedure or SOP: 🗣️ Dialogue. Whenever we dis...
Galit Lisaey/
Risk Management and Running Shoes
It’s widely accepted today that #Data is one of our most valuable resources. Every decision we make — big or small — relies on information derived from data....
Galit Lisaey/
You Don't Change the Oil Filter on a Parked Car
You Don't Change the Oil Filter on a Parked Car A brilliant quote (not mine!) from my outsourcing partner, during a deep discussion on UAT — User Acceptance Tes...
Galit Lisaey/
Risk management is not task management
In every project, open issues arise. They’re not necessarily risks – but if left unresolved, they might become one. Not long ago, I sat with a frustrated proje...
Galit Lisaey/
Disclaimer: The content reflects professional knowledge and experience only and does not constitute specific advice. Each organization should perform its own professional assessment before implementation.