Data Integrity

Data Integrity is the state of data being complete, consistent, and accurate throughout its entire lifecycle. It is paramount in the regulated life sciences industry (GMP/GDP) to ensure product safety, efficacy, and quality. Regulators emphasize strict adherence to the ALCOA++ principles to maintain the reliability of electronic records and audit trails, especially concerning raw material testing, batch release, and validation activities. A robust Data Governance framework is essential for preventing data manipulation, mitigating risks in computerized systems, and ensuring audit-readiness in automated and digitalized environments.