New Release — 2026
Data Integrity
By Design
Building Systems That Regulators Trust
The definitive practical guide for QA professionals, compliance leaders, and clinical data teams who need to build systems that pass inspection—not just documentation that says they do.
Christopher L. Gent
Data Integrity
By Design
Building Systems That
Regulators Trust
AcceleraQA Press — 2026
"Data integrity failures are design failures. The organizations that understand this will build different programs than the ones that treat compliance as documentation."
— Christopher L. Gent, Data Integrity By Design
Why this book exists
Every year, organizations spend hundreds of millions of dollars responding to FDA warning letters, consent decrees, and clinical holds—nearly all of them preventable. The warning letter doesn't arrive because of fraud. It arrives because systems were designed to produce compliant documentation, not accurate data.
This book maps the gap between those two things: compliance as paperwork and integrity as architecture. It draws on the FDA enforcement record, global regulatory frameworks, and two decades of clinical quality evidence to give QA teams the design principles they need before an investigator arrives—not after.
Inside the Book
Four parts. Sixteen chapters. One framework.
From regulatory foundations to AI and cloud-era challenges, every chapter is built around a single question: does this design make compliant behavior easier than the non-compliant alternative?
The Foundation
Understanding where we are and how we got here
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01
The Cost of Getting It Wrong
The enforcement record and what warning letters actually cost—direct and total.
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02
Data Integrity by Design: The Core Philosophy
What it means to build integrity into systems rather than document it after the fact.
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03
A Brief History of Clinical Data Integrity Regulation
How the regulatory framework evolved and why the current moment is different.
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04
The Global Regulatory Landscape
FDA, EMA, MHRA, and beyond—what each regulator actually requires.
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05
ALCOA+ Decoded
What regulators actually mean by each attribute and what they look for in inspection.
Designing for Integrity
The technical architecture of compliant systems
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06
The Data Lifecycle: From Creation to Archive
Every stage where integrity can be gained or lost, and the controls that protect each.
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07
Computer System Validation in the Modern Era
Risk-based CSV approaches that satisfy regulators without organizational paralysis.
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08
Audit Trails: The Heartbeat of a Compliant System
What audit trails must capture, what investigators look for, and how to design them right.
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09
Electronic Records and Signatures: Getting It Right
21 CFR Part 11, Annex 11, and the practical requirements behind the regulations.
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10
Decentralized and Hybrid Trials: New Frontiers
How DCT models expand the data integrity surface and what that demands from sponsors.
The Human System
Culture, leadership, and training that actually works
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11
The Role of Leadership in Data Integrity
Why leadership engagement is the single most reliable predictor of program success.
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12
Culture Is the Control
Building a data integrity mindset that holds under real operational pressure.
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13
Training That Actually Works
Competency-based training that produces coordinators who understand why, not just that.
Emerging Challenges
AI, cloud, and the inspection you don't know is coming
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14
AI: Integrity in the Age of Intelligent Systems
How AI changes the data integrity obligation and what governance looks like in practice.
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15
Cloud, SaaS, and Third-Party Systems
Vendor oversight, shared responsibility models, and qualification in the cloud era.
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16
Preparing for the Inspection You Don't Know Is Coming
How BIMO and EU GCP investigators work, and how to apply their methods to yourself first.
The Framework
Five questions to take back to your organization
The book closes with a diagnostic framework any quality leader can apply immediately. These are the questions investigators can answer about your organization—the question is whether you answer them first.
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1
Does our quality system find problems, or does it file documentation of having looked?
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2
Are our systems designed so that compliant behavior is easier than the non-compliant alternative under realistic operational pressure?
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3
Does our leadership treat data integrity as an operational reality requiring their engagement, or as a quality department concern?
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4
Have we conducted the inspection of our own data applying the same analytical methods regulators use, before the next scheduled inspection?
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5
When our quality system identifies a data integrity signal, does it reach someone with the authority to address the design condition that produced it?
Coming Soon
The Companion Volume
Data Integrity in Practice: Building, Measuring, and Sustaining Your Program
The design principles established in Data Integrity By Design are the foundation. The companion volume provides the implementation architecture: gap assessment methodology, resource allocation frameworks, metrics that tell leadership whether the program is working, and orientation toward regulatory developments arriving in the next several years.
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From Book to Practice
Put the principles to work with AcceleraQA
The framework in this book is only as valuable as your team's ability to apply it. AcceleraQA's AI-powered learning platform delivers the GxP mastery your organization needs—personalized adaptive learning, real-time regulatory updates, and interactive simulations that build the culture this book describes.
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