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 be recorded in real-time or as soon as possible after the event occurred. This means that data should be entered, recorded, or documented as it occurs, in real-time or shortly thereafter.

Original: The original record must be maintained, meaning that it must be a true copy of the original data. The original record must be preserved in its original form and format without alteration, so it can be used to verify the data's authenticity.

Accurate: Data must be accurate, meaning that it must reflect the true state of the information it represents. Data must be recorded using appropriate methods, such as validated instruments, to ensure accuracy.

Complete: Data must be complete, meaning it must contain all relevant information required to make informed decisions. This includes all raw data and metadata, as well as any additional supporting documentation.

Consistent: Data must be consistent, meaning that it is the same across all systems, applications, and platforms within the organization. Data must be recorded in a standardized format and using consistent methodologies and processes.

Enduring: Data must be enduring, meaning that it must be preserved and accessible for the life cycle of the product or for the length of time required by regulatory agencies. Data must be stored in a secure, protected, and tamper-evident manner.

Available: Data must be available, meaning that it must be retrievable, accessible, and usable throughout its life cycle. Data must be stored in a manner that ensures it is available to authorized personnel when needed.

In summary, ALCOA+ is a set of data integrity principles that require data to be attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available. By following these principles, pharmaceutical and biotechnology organizations can ensure the reliability, accuracy, and completeness of their data, which is essential for regulatory compliance and maintaining public trust.