What is ALCOA+ (plus) / ALCOA+ details / ALCOA+ Principle

ALCOA+ is an acronym used for data integrity purposes. This article introduces the Origin of ALCOA+, what is ALCOA+, and the term ALCOA+.

The ALCOA acronym was introduced by Stan W. Woollen ( currently Senior Compliance Advisor and Associates) in the FDA office early 1990’s. ALCOA Inc. is a commonly known company. so, he incorporated this acronym in his slide. Many times he introduced this word and explained what is ALCOA. Hence, this word is commonly used in the pharmaceutical sector.

ALCOA represents the terms Attributable, Legible, Contemporaneous, Original, Accurate. But now, ALCOA is outdated and ALCOA+ is the updated concept. It’s just like GMP to cGMP. This “+” represents Available , Enduring, Complete, Consistent. This “+” also indicates that in the future new terms will be added and as part of ALCOA. Many of Pharma industry and regulatory bodies like FDA, WHO etc follow this concept.

 

1. Attributable

Clearly indicates who recorded the data / performed the activity with sign data (manually/electronically). Record who wrote it and when. FDA requirement is data should be trace or link with its source like study, analytical run, test system, etc. This concept is applicable for original data as well as any change in data both should be sign and date by an individual.

Refer USFDA guideline 21 CFR 58.130 (c) and (e)

2.  Legible (Readable)

Data should be readable after it is recorded. Data is recorded permanently in a long-lasting (durable) medium like a pen, non-removable ink. This is applicable for both printed and handwritten documents.

Refer USFDA guideline 21 CFR 58.130 (c) and (e)

3.  Contemporaneous (Online Record)

Record the data at the time it was generated i.e. contemporaneously. It is well known online recording of data. If more promptly (no delay) data is recorded, better the quality. The date of data entry should be required.

Refer USFDA guideline 21 CFR 58.130 (e)

 4.  Original

Prevent data in its unaltered state like raw data, source data. This is the first data generated electronically or manually.

Refer USFDA guideline 21 CFR 58.130 (e)

5.  Accurate

Data reflect its actual value / trueness, free from error. Accuracy of data indicates quality.

Refer USFDA guideline 21 CFR 58.35 (b) (6)

Refer USFDA guideline 21 CFR 58.130 (a) and (b)

6.  Available

Data should be available for review at any time until the defined storage of the document. Available at the time of audit and whenever required for review.

7.   Enduring

Making sure records exist for the entire period and readable condition.

8.  Complete

Data must be incomplete state to avoid recreation/ manipulation. The required level of details fulfills in the documents consider as complete. Complete records show its data reliability and quality.

9.  Consistent 

Good Documentation Practices should be applied throughout any process for consistency in documentation. Available data should be in a sequential manner with a sign and date. Time should be in the correct sequence to show the reliability and consistency in the process and activity performed.

Summary of ALCOA+

 Reference

The Compass – Summer 2010 Newsletter of the Southern Regional Chapter Society or Quality Assurance Data Quality and the Origin of ALCOA

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