ALCOA Data Integrity Explained | Pharma Qualification
FDA ALCOA Data Integrity Guide
In its 2003 guidelines on implementing its data integrity standard 21CFR Part 11 , the FDA uses the acronym ALCOA, which defines good data integrity practice as creating records that are attributable to the technician who performs the tests, legible, created in a contemporary way, original and accurate.
ALCOA: Attributable, Legible , Contemporary, Original, Accurate
The FDA 21CFR part 11 ALCOA definition of complete, consistent and accurate data
Attributable
It can be interpreted that “attributable” means that the records must include an electronic “signature” that links them to the instrument / person who performed the measurement and that they must also include a reference to the water system being tested and the date and time when he took. This implies electronic signatures for users who log in to the system. Control over the electronic signature format may be installation specific and is normally controlled by the IT department using Microsoft Active Directory controls. Ideally, online instrumentation should be configured to follow Active Directory controls to ensure the correct electronic signature format according to the specific rules of the facility.
Legible records
The record needs to be readable, which implies that handwritten records are not acceptable. The FDA further suggests that electronic records should be stored in an open format and readable on many computer systems so that they can be accessible and readable for years. The FDA recommends typical formats such as PDF, XML, or SGML.
Contemporary
The word “contemporary” implies that electronic records should be created immediately, as soon as the sample has been measured, that manual transcription of paper records is not good practice, and that the collection of paper records and subsequent transcription manually in format Electronic is also not a good practice.
Original
Naturally, there is a risk with each transcription of test results from one form to another. Even scanning multiple paper records into electronic format runs the risk of duplication or missed scans. Therefore, the FDA recommends that the electronic record be the original record that was created when the test was completed. Obviously, manually transcribed records are the riskiest, with the highest risk and opportunity for human error.
Attributable records
Finally, the last A of ALCOA. Naturally, electronic records must be accurate. This implies that the process of capturing such electronic records must be sound, that is, manual calculations and manual data entry with opportunities for human error should be avoided. Attributable is the first “A” of ALCOA Data Integrity. The electronic records generated by the online instruments must contain information that links the data with the instrument used to carry out the measurement and the date and time of the measurement.
