Data

Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation.…

Data Governance

Data governance encompasses the organizational and technical structures that keep data available, with integrity – changeable under control and traceable – and ALCOA++-compliant across the entire data lifecycle. This includes roles and responsibilities, decision-making functions and committees, and controls –…

Data Integrity

Data integrity is the degree to which a collection of data is complete, consistent and accurate throughout the data lifecycle. The collected data should meet the ALCOA++ criteria. Ensuring data integrity requires appropriate quality and risk management systems and compliance…

Data Lifecycle

The data lifecycle covers all phases data passes through – from creation to archiving or deletion. Data risks are assessed and managed in a way that reflects their potential impact on Product quality, Patient safety and/or the reliability of the…