Data Integrity and Compliance

Data Integrity Is A Global Mandatory Requirement For The Regulated Healthcare Industry. It Is More Than A Mere Expectation-It'S A Basic Element Of Good Documentation Practices, One Of The Most Fundamental Pillars Of A Quality Management System. Robustness And Accuracy Of The Data Submitted By Manufacturers To Regulatory Authorities When Bringing A Medical Product To Market Are Crucial. The Purpose Of This Book Is To Consolidate Existing Data Integrity Principles And Expectations From Several Regulatory Sources-Including The U.S. Food And Drug Administration, World Health Organization, And European Medicines Agency-Into A Single And Handy Document That Provides Detailed, Illustrative Implementation Guidance. It Serves As A Means Of Understanding Regulatory Agencies' Position On Good Data Management And The Minimum Expectation For How Medical Product Manufacturers Can Achieve Compliance.