ALCOA, ALCOA+, AND ALCOA++

ALCOA is an acronym representing key principles for ensuring data integrity, particularly in the pharmaceutical, biotechnology, and medical device industries. These principles ensure that all data generated meets quality and compliance standards, especially in clinical trials or manufacturing processes, as well as late-stage development or any work/data cited on any drug application or supplement. The FDA and other global regulatory bodies emphasize adherence to ALCOA principles:

• Attributable: Each data point must be traceable to the individual who generated or modified it, providing accountability.
• Legible: Data must be clear, readable, and understandable, ensuring accurate interpretation.
• Contemporaneous: Data must be recorded in real-time or as close as possible to the time of the event, to ensure accuracy.
• Original: The first or source data (often referred to as raw data) should be preserved. Any derived data must maintain a clear link to its original source.
• Accurate: Data must be correct, complete, and truthful, with minimal errors or ambiguities.
• +: Complete, consistent, enduring, and available data.
• ++: Traceable data.

Adhering to ALCOA++ ensures trustworthiness in data collection, storage, and reporting, particularly in regulated environments like clinical trials or GMP (Good Manufacturing Practices) settings.