Assessment of Data Integrity Gaps and Preventive Strategies in QC Laboratories in Compliance with FDA and CGMP Expectations

Abstract

Laboratory data integrity is a fundamental requirement for ensuring the reliability, accuracy, and traceability of analytical results generated within pharmaceutical quality control (QC) laboratories. Compliance with the United States Food and Drug Administration (FDA) regulations and Current Good Manufacturing Practice (CGMP) expectations requires organizations to maintain complete documentation, validated computerized systems, effective audit trail management, qualified personnel, comprehensive quality oversight, and sustainable preventive quality management practices. This study assessed data integrity gaps and preventive strategies implemented in pharmaceutical QC laboratories and examined their influence on overall laboratory compliance performance. A quantitative cross-sectional research design was employed using a structured questionnaire administered to professionals involved in quality control, quality assurance, validation, regulatory compliance, and laboratory management. The study investigated the relationships among laboratory data integrity gaps, preventive quality management strategies, and compliance performance while evaluating documentation practices, electronic record management, computerized system validation, audit trail review, personnel training, corrective and preventive action (CAPA) implementation, internal audit systems, risk-based monitoring, and management review. Statistical analyses included descriptive statistics, reliability and validity assessment, correlation analysis, and multiple regression analysis to evaluate the proposed conceptual framework and research hypotheses. The findings indicated that laboratory data integrity gaps adversely affected compliance performance, whereas preventive quality management strategies significantly strengthened documentation quality, computerized system reliability, audit readiness, regulatory preparedness, and overall laboratory governance. Preventive measures, including standardized operating procedures, routine audit trail monitoring, effective personnel training, independent quality assurance oversight, timely CAPA implementation, and structured management review, were associated with stronger laboratory compliance and improved data integrity performance. The study concluded that sustainable compliance with FDA and CGMP expectations depends upon an integrated quality management system that combines technical controls, organizational governance, personnel competence, and continuous quality improvement. The findings contribute to pharmaceutical quality management by providing an evidence-based framework for strengthening laboratory data integrity, improving regulatory compliance, enhancing analytical reliability, supporting product quality, and protecting patient safety through proactive organizational quality practices.