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Ensuring Enterprise-Wide Data Integrity in FDA-Regulated Industries

How to prevent compliance issues and implement an effective control framework for data integrity

Data integrity issues are among the most significant compliance problems manufacturers struggle with today.

All too often, the scope of data integrity is misunderstood and oversimplified. Managing data and the systems that govern it stretch far beyond the IT department to encompass C-level executives and support groups in the areas of engineering, manufacturing, and quality. It requires a company-wide commitment to quality management that starts at the top.

This white paper offers a purely practical perspective on what data integrity is and how to mitigate data-related issues by developing and implementing a sound control framework. We'll also offer solutions to common data integrity problems.

What you'll find inside:

• A practical perspective of data integrity
• Human factors, procedural controls, & technical controls related to data integrity
• Steps company leaders can take to create a culture of integrity within their organization
• A guide to sound data management and data governance practices
• Specific actions you can take to prevent common data integrity problems and subsequent enforcement actions
• Industry insights from top data integrity & CSV experts

Meet the contributors

Chinmoy Roy

Chinmoy offers over 37 years of U.S.-based subject matter expertise in the design, development, QA, validation, and CFR 21 Part 11 implementation for automation and computerized systems. As a principal Lead Engineer, Chinmoy directed several engineering teams to design, commission, validate, and obtain USFDA certification for multimillion-dollar computerized control systems.

Jose Gutierrez

Jose has 26 years’ experience working in the bioscience pharmaceutical industry. For over two decades, he has lead projects in the areas of quality, FDA audits, corporate audits, facility audits, regulatory compliance, investigations, protocols, consent decree remediation, manufacturing, capacity expansion, APIs, injectable dosage, solid dosage, sterility, CAPAs, formulation, medical devices, environmental, formulation, and batch records.