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But now, ALCOA is outdated and ALCOA+ is the updated concept.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 FDA, WHO etc
follow this concept.
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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.
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Summary of ALCOA+ |
Reference
1 comments:
Click here for commentsVery good info sir.
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