ALCOA is an acronym that describes the most important principles of data integrity (German translation: Datenintegrität) in a pharmaceutical quality system. It includes the following components:

• Attributable: It must be possible to trace the data back to the person who created the data set and carried out a specific activity.
• Legible: The data must be legible.
• Contemporaneous: Data is to be recorded at the time it is received or observed, i.e. when the activity is carried out.
• Original: The data must be original, primary data.
• Accurate: The data must be correct and free from error.

These principles apply to data generated by both electronic and paper-based systems and are part of Good Documentation Practice (GDocP; German: Gute Dokumentationspraxis), which is integrated into the pharmaceutical quality system.

ALCOA+ is an extended version of ALCOA that contains additional attributes that allow for more comprehensive monitoring of data integrity. These additional attributes include:

• Complete: All data must be available, i.e. nothing may be omitted or deleted.
• Consistent: The data is recorded in a consistent manner and in chronological order and including the date and time.
• Enduring: The data must be recorded directly onto controlled media and remain available in a non-erasable format for the entirety of the necessary period. Thermal paper (German translation: Thermopapier), for instance, should not be used for paper records.
• Available: The records, both in paper and electronic form, must be available for inspection at any time during the prescribed retention period.

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