ALCOA plus: data integrity in pharma, explained

What does each letter of ALCOA plus mean?

• Attributable: you can tell who created or changed the record, and when. No shared logins.
• Legible: it can be read and understood for its whole life, including any corrections.
• Contemporaneous: written at the time the work was done, not at the end of the shift.
• Original: the first capture of the data, or a certified true copy of it.
• Accurate: correct, with no unrecorded edits.
• Complete: nothing left out, including repeat tests and failed runs.
• Consistent: dates, times and sequence agree across systems.
• Enduring: kept on a durable medium for the full retention period.
• Available: it can be found and read when an auditor or inspector asks.

What is data integrity in pharma, and which rules require it?

In Europe the obligations sit in EU GMP Chapter 4 on documentation and EU GMP Annex 11 on computerised systems. In the United States they sit in 21 CFR Part 11 on electronic records and signatures and in the drug GMP rules of 21 CFR 211. The regulators have also published guidance on how they read those rules: the MHRA data integrity guidance of 2018, the FDA guidance on data integrity and drug GMP of the same year, and PIC/S PI 041-1 from 2021, which inspectors in PIC/S member countries use as their reference.

What do inspectors look for first?

They rarely start with the policy. They sit at a chromatography workstation and ask to see the audit trail. Common findings are audit trails switched off, shared user accounts, trial injections run before the official one, results reprocessed without a reason, and printouts treated as the record while the electronic data is ignored. On paper, they look at blank forms that nobody controls and corrections that hide the original value.

ALCOA plus with examples from a supplier

A quality control analyst who notes a weight on a scrap of paper and copies it into the logbook later breaks Contemporaneous and Original. A plant that keeps batch records but deletes the failed test that came before the passing one breaks Complete. A company whose server clock is an hour off from the instrument clock breaks Consistent.

How do you train staff on data integrity?

EU GMP and 21 CFR 211 both require training that fits the job and a record that proves it. Our courses below teach ALCOA plus by role, end every module with a recorded questionnaire, and give each learner a certificate and a training record that an inspector can read.

This guide belongs to Training for IT, data and validation in pharma: 36 audio courses, 36 courses.