Definition of ALCOA Plus:
Attributable means recording who performed an action and when. And, if a record is changed, who did that and why.
Legible means that the data must be recorded permanently in a durable medium and should be readable.
Contemporaneous means that the data should be recorded at the time the work is performed, and the date and time stamps should follow.
Original data includes the first capture of data or information and all subsequent data required to fully reconstruct the conduct of the GMP activity.
Accurate means data collected is correct, truthful, complete, valid and reliable.
Complete is the data must be whole i.e. complete set including repetitions.
Consistent application of data timestamps in the expected sequence.
Enduring is durable. i.e.lasting throughout the data lifecycle.
Available is readily accessible for review or audit for the lifetime of the record.
For interview preparation refer
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