6 BioPharm International eBook March 2020 www.biopharminternational.com
ALCOA+ and Data Integrity
Data supporting the quality and safety of product must meet the
ALCOA+ elements in order to avoid regulatory citations for data
integrity issues.
D
ata supporting the quality and safety of
product must meet the ALCOA+ elements
in order to avoid regulatory citations
for data integrity issues. The acronym
ALCOA requires data be attributable, leg-
ible, contemporaneous, original, and accurate. The
acronym ALCOA+ adds the concepts that, in addition
to ALCOA, data also needs to be complete, consistent,
enduring, and available. It is important to understand
what each element of ALCOA and ALCOA+ mean in
order to apply the concepts appropriately with respect
to a company's records.
The following are some general definitions, para-
ph r a s e d f r om t he Ph a r m ac e ut ic a l I n s p e c t ion
Co-operation Scheme (PIC/S) (1), that can be used for
understanding the elements of ALCOA and ALCOA+:
• Attributable: The data generated or collected
must be traceable back to the individual who
generated the information.
• Legible: The data recorded must be readable and
permanent.
• Contemporaneous: The results, measurements,
etc. must be recorded at the time the work is
performed.
Skórzewiak
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Stock.adobe.com
SUSAN J. SCHNIEPP
Regulatory Sourcebook Data Integrity
SUSAN J. SCHNIEPP is executive vice-president of post-approval pharma and
distinguished fellow, Regulatory Compliance Associates.