Are you familiar with data integrity ALCOA+ principles?
Global regulators expect to see robust data integrity within organizations and that decision-making is based on high-quality data. In addition to FDA, PIC/S, EMA, WHO, and OECD all have data integrity guidelines.
Poor data integrity practices can result in enforcement actions:
- 483 observations
- Warning letters
- Product recalls
- Consent decrees
In the 1990s, an FDA official developed an acronym for data integrity requirements, ALCOA, which stands for “attributable,” “legible,” “contemporaneous,” “original,” and “accurate.” This acronym is now “ALCOA+, the “+” adding the concepts of “complete,” “consistent,” “enduring,” and “available.”
“Complete” means that all information is included with nothing missing. “Consistent” refers to using approved data acquisition and analysis while “enduring” involves using media that maintains records and does not deteriorate over time. And “available” means that records are accessible at any time.
Data Integrity Hides in “Plain Sight”
It is important to be aware that when analyzing warning letters, it is rare for FDA to use the phrase “data integrity.” Instead, data integrity violations are often cited under specific CFR citations, such as CFR 211.100 which addresses not following procedures. This CFR is generally used when documentation is not “contemporaneous.”
In addition to pharmaceutical GMP operations, data integrity is also a crucial linchpin for clinical trials. Data from the Redica Systems GCP expert model shows that more than half of 1,200 483 observations issued to clinical investigators are data integrity violations. The three most common observations involve original data, lack of appropriate attribution, and inaccurate data.
The data integrity bottom line? ALCOA is more than just one of the world’s largest producers of aluminum, it is something regulators expect to see as the underpinnings of a robust data integrity program.
Additional Data Integrity Resources
Redica Systems can help you stay on top of the latest data integrity enforcement trends. Contact us today to see how easy it is to access this intelligence using our platform.
Subscribe to Redica Insights
Get quality and compliance insights from our experts in your inbox