SOP/Template

ALCOA Checklist for Data Integrity Audits

Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data be attributable, legible, contemporaneously recorded, original or a true copy, and accurate. 

Data integrity should be maintained throughout the data life cycle, including, but not limited to data creation, processing, archiving and disposition after the record's retention period. 

During a data integrity system review, there is data that must be checked and verified. Data has varying importance to quality, safety, and efficacy decisions. Its criticality may be determined by considered how the data is used to influence the quality, product, and process decisions made. The risks to the data should be determined by the manufacturers and accessed by the life cycle. 

In order to have good data and record management, regulatory agency suggest that organizations have ALCOA data. ALCOA stands for: 

A - Attributable to the person generating the data

L - Legible, traceable, and permanent

C- Contemporaneous

O - Original record (or certified true copy)

A- Accurate

Esteemed speaker, Sean Osso, from our recent Computer & Software Validation event, created a checklist to make sure you and your teams have ALCOA data. 

For a further breakdown of data integrity and ALCOA, download Osso's presentation on "Preparing for a Comprehensive Data Integrity Audit."

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