The ALCOA principle aims to ensure data integrity and data quality in records. ALCOA stands for:
- Attributable - Data must be traceable to a specific source or person.
- Legible - Data must be readable and permanent.
- Contemporaneous - Data should be recorded at the time of the activity or observation.
- Original - Data should be in their original, unaltered form.
- Accurate - Data must be correct and error-free.
The ALCOA++ principle extends the original ALCOA concept to consider additional attributes of data integrity in regulated environments such as the GxP environment. This extension includes further criteria:
- Complete - All data must be complete and comprehensive.
- Consistent - Data should be in a reliable and logical format.
- Enduring - Data must be preserved over time.
- Available - Data should be accessible whenever needed.