AcceleraQA Resources
Publications, tools, and content from Christopher L. Gent and AcceleraQA — curated for quality and compliance professionals in regulated industries.
Building Systems That Regulators Trust
The definitive practical guide to clinical data integrity for QA professionals, compliance leaders, and clinical data teams. Four parts, sixteen chapters, one framework — built around the FDA enforcement record and two decades of clinical quality evidence.
Building, Measuring, and Sustaining Your Program
The companion volume to Data Integrity By Design. Implementation architecture: gap assessment methodology, resource allocation frameworks, metrics that tell leadership whether the program is working, and orientation toward upcoming regulatory developments.
Mark S. Dacey, M.D. — with Integrity Impact
A finding-by-finding comparison of the Form FDA 483 issued to clinical investigator Mark S. Dacey, M.D. and the warning letter issued fifteen months later. Includes integrity impact by ALCOA+ dimension, escalation rationale for each observation, and the three drivers behind FDA's single cited violation.
Regulatory Intelligence for Life Sciences Professionals
Practitioner commentary on FDA enforcement trends, new guidance interpretation, inspection readiness, and what regulatory changes mean for your quality system — written for professionals who need to act, not just read.
AI-Enabled Compliance Intelligence for Life Sciences
Real-time regulatory monitoring, AI compliance gap analysis, and inspection readiness tools — built for pharmaceutical, biotech, and CRO quality teams. Continuously updated across FDA, EMA, ICH, MHRA, and global regulatory bodies.
Available for conference presentations, webinars, and organizational training on data integrity, GxP compliance, and regulated systems design.
Quantity pricing available for organizations, training programs, and conferences. Contact us for volume discounts and licensing.
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