ALCOA/ALCOA+ is a framework or set of principles that ensures data integrity. Where ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate; and ‘+’ (Plus) means Enduring, Available, Complete and Consistent.
5 Principles of Data Integrity
Attributable
The collected data must be attributed, who performs the action and when, if a record is changed, who did it and why to be recorded.
Legible
Data must be recorded permanently in a durable record medium and easy to read.
Contemporaneous
The data should be recorded at the time and date of work performed. The timestamp should we follow in order.
Original
The information must be recorded as original or in a certified true or original copy; this may be an acceptable protocol or a database or a notebook.
Accurate
No error or editing was performed without documented amendments to ensure the accuracy of the data and records.
ALCOA Plus (+)
Complete
All data should be complete manner.
Consistent
Consistent in a generation of record and application of date and time stamps in the expected sequence.
Enduring
Data should be recorded in a controlled worksheet in laboratory notebooks or validated Electronic systems.
Available
Data need to be available and accessible for review for audit and inspection over the lifetime of the record.
Data integrity is a key element in pharmaceutical industry to ensure products meet all the quality standard parameters up to the end of products. It is also a process of maintaining and assurance of accurate and consistency of data over its whole life cycle.
As per FDA,
Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).
The main principle of ALCOA is to minimize the risk of data integrity. It was introduced and still used by FDA – the US Food and Drug Administration. It has relevance in a range of areas particularly in relation to pharmaceutical research, manufacturing, testing, and the supply chain.
FDA encourages to demonstrate that you have effectively remedied your problems by: hiring a third party auditor, determining the scope of the problem, implementing a corrective action plan (globally), and removing at all levels individuals responsible for problems from cGMP positions. FDA may conduct an inspection to decide whether cGMP violations involving data integrity have been remedied.
ALCOA Data Integrity Examples
- All data to be recorded on time with right person.
- All recorded data to be sequentially recorded with maintaining time and date.
- Any change or correction should be record clearly.
References:
- Data Integrity and Compliance With cGMP Guidance for Industry, April 2016
- MHRA GMP Data Integrity Definitions and Guidance for Industry, March 2015
- 21 CFR Part 11, Electronic Records; Electronic Signatures
Read also: Data Integrity Checklist for Pharmaceutical Industry
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