Data Integrity in Pharmaceutical Manufacturing
Ensuring Trust, Compliance, and Patient Safety
$14.95
In today’s pharmaceutical industry, data integrity is non-negotiable. Every batch record, every instrument log, and every digital entry can determine whether a product is deemed safe or pulled from the market. Regulatory agencies like the FDA, EMA, and MHRA continue to rank data integrity failures among the top causes of warning letters and import alerts.
This comprehensive ebook provides a clear, practical roadmap for ensuring data integrity across the pharmaceutical lifecycle. Designed for QA professionals, validation engineers, and compliance leaders, it bridges the gap between regulations and daily practice.
✅ Inside, You’ll Discover:
The foundations of ALCOA+ principles and how to apply them consistently.
Real-world case studies of data integrity failures and the lessons learned.
Strategies for digital data governance, including electronic systems, audit trails, and metadata controls.
How to integrate data integrity into GMP processes, from manufacturing to QC labs.
Practical checklists and templates to strengthen compliance and audit readiness.
💡 Why This Ebook Matters
Data integrity isn’t just a regulatory requirement it’s the foundation of patient trust and the license to operate in pharma. With increasing digitization and global supply chains, mastering data integrity is the key to reducing risk, avoiding citations, and ensuring product quality.
