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

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

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

The ALCOA the 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 But now, ALCOA is outdated and ALCOA+ is the updated concept.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 just like GMP to cGMP. This “+” represents Available , Enduring, Complete, Consistent. This “+” also indicates that in future new terms will be added and as part of ALCOA. Many of Pharma industry and regulatory bodies like FDAWHO etc follow this concept.

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


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 recorded permanently in long-lasting (durable) a 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 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. 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 shows the reliability and consistency in the process and activity performed.

 

Definition of ALCOA+, Summary of ALCOA+, Data integrity

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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Unknown
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August 22, 2020 at 10:38 AM ×

Very good info sir.

Congrats bro Unknown you got PERTAMAX...! hehehehe...
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