ALCOA Principles for Data Integrity

ALCOA is an acronym that stands for Attributable, Legible, Contemporaneous, Original, and Accurate. It is a set of data integrity principles that are widely used in the pharmaceutical industry to ensure the quality and integrity of data generated during drug development and manufacturing.

Attributable: 

Information is captured that identifies the source of the data

Example: Signature of operator after completion of task.

Legible: 

Information is readable

Example: Clear handwriting, so everyone can read it and understand

Contemporaneous: 

Information is recorded at the time of data generation or event observation/ On time recording

Example: Immediate recording of LOD test data

Original:

Data should be used or presented as it was created the first time.

The original record is the first-capture of information, whether recorded on paper (static) or electronically (dynamic or static).

Example: Tested data on print-out is original data if there is no e-record. Manual data entry in logbook if no print/e-record.

Accurate: 

Data can be verified as correct via repeatable calculation, algorithm, or analysis

Example: 4-eye principle/ second person check

In the pharmaceutical industry, the use of ALCOA principles helps to ensure that the data collected during clinical trials, laboratory testing, and manufacturing is accurate and reliable, and can be used to support regulatory submissions and approvals. This is especially important in the pharmaceutical industry, where even small inaccuracies in data can have significant consequences for patient safety and regulatory compliance.

These original ALCOA principles have since been updated to ALCOA+. The original principles remain with four additions:

• Complete
• Consistent
• Enduring
• Available

Complete

Information that is critical to recreate the activity is retained

Example: Fill-up all blank space in Form, cross-out remaining blank space

Consistent

Good documentation practices are in place throughout the process.  

Example: GDP procedure is followed all time

Enduring

Ensuring the data are retained and secure for the entire period over which they are needed or required to be maintained. 

Example: Archived record

Available

Data and associated metadata must be available for review at any time during the defined retention period.  

Example: Access to archive to read/ review the data

By applying the ALCOA principles, pharmaceutical companies can ensure that the data generated during drug development and manufacturing is of the highest quality and can be used to support regulatory approvals and ensure patient safety.