FDA ALCOA Guidance

Maintaining Data Integrity: Understanding FDA ALCOA Guidance

Did you know that lack of data integrity has been a top reason for FDA Drug GMP warning letters?
In their 2003 guidance on the implementation of their 21 CFR part 11 data integrity rule, the FDA use the acronym ALCOA, where they define good data integrity practice as creating records that are attributable to the technician carrying out the testing, are legible, are created contemporaneously, original and accurate.
Attributable can be interpreted to mean that records should include an electronic ‘signature’ to link them to the instrument/person that made the measurement and they should also include a reference to the water system being tested and the date and time it was taken. This implies electronic signatures for users signed on to the system. Control over electronic signature format can be site specific and is usually controlled by the IT department using Microsoft Active Directory controls. Ideally the on-line instrumentation should be configured to follow Active Directory controls to ensure correct electronic signature format according to the site-specific rules.
Legible records
The record of course is required to be legible, which implies that hand-written records are not acceptable. The FDA goes on to suggest that electronic records should be stored in a format that is open and can be read on many computing formats so that it will be accessible and readable for years to come. The FDA recommends typical formats such as PDF, XML or SGML.
The word contemporaneously implies that the electronic records should be created immediately when the sample is measured, implying that manual transcription of paper records is not good practice and that collating paper records and then manually transcribing them into electronic format at a later time or date is not good practice either.
Naturally there is a danger with every 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. So the FDA recommends that the electronic record should be the original record created when the test was completed. Obviously, manually transcribed records are the riskiest, attracting the biggest opportunity for human error.
Accurate records
Finally the A in ALCOA. Naturally the electronic records should be accurate. This implies that the process for capturing those electronic records should be robust, i.e. manual calculations and manual data entry where opportunities for human error exist should be avoided. Electronic records generated by on-line instruments should contain information that links the data to the instrument used to make the measurement and the time and date of the measurement.
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