Basic of ALCOA+ Data Integrity Principle
Data integrity is a fundamental aspect of any pharmaceutical or biotechnology organization. Regulators such as the FDA, EMA, and MHRA require that data be reliable, accurate, and complete, and meet certain standards for documentation and data security. To meet these requirements, pharmaceutical and biotechnology organizations must follow specific data integrity principles. One such principle is ALCOA+. ALCOA+ is an acronym that stands for Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available. Attributable: Data must be attributable to the individual who performed the activity, made the observation, or collected the data. This means that all data must be linked to a specific user, so it is clear who was responsible for generating the data. Legible: Data must be legible, meaning it must be readable, clear, and comprehensible. It is crucial to ensure that data is not subject to misinterpretation or misreading. Contemporaneous: Data must