ALCOA+
ALCOA+ has been adopted by various industries as a framework for ensuring that data security and integrity is observed and maintained. It is in use by various big bodies such as the FDA and WHO. It is all about data quality.
ALCOA+ extends ALCOA with:
- Complete: All information must be available.
- Consistent: Data is presented, recorded, dated, or timestamped in the expected and defined sequence.
- Enduring: Data must not get lost over time.
- Available: Data must be retrievable.
Complete
All data MUST be retained since creation. Data MUST not be deleted in a way that the source gets lost.
For electronic systems an Audit Trail MUST prove that nothing has been deleted or lost.
Consistent
The data is presented, recorded, dated, or timestamped in the expected and defined sequence.
Enduring
The data or information must be maintained, intact, and accessible throughout the defined Retention period.
Available
Data should be readily retrievable and readable throughout the Retention period.
Sources
- https://www.pharmaguideline.com/2018/12/alcoa-to-alcoa-plus-for-data-integrity.html
- https://www.ideagen.com/thought-leadership/blog/how-to-meet-all-9-alcoa-principles-with-our-document-module
- https://www.pharmtech.com/view/alcoa-and-data-integrity
- https://blink.ucsd.edu/research/_files/ALCOA-Standards-210304.pdf