Definition of ALCOA Plus

Definition of ALCOA Plus:

1. A-Attributable:

Attributable means recording who performed an action and when. And, if a record is changed, who did that and why.

2. L-Legible:

Legible means that the data must be recorded permanently in a durable medium and should be readable.

3. C-Contemporaneous:

Contemporaneous means that the data should be recorded at the time the work is performed, and the date and time stamps should follow.

4. O-Original:

Original data includes the first capture of data or information and all subsequent data required to fully reconstruct the conduct of the GMP activity.

5. A-Accurate:

Accurate means data collected is correct, truthful, complete, valid and reliable.

6. C-Complete:

Complete is the data must be whole i.e. complete set including repetitions.

7. C-Consistent:

Consistent application of data timestamps in the expected sequence.

8. E-Enduring:

Enduring is durable. i.e.lasting throughout the data lifecycle.

9. A-Available:

Available is readily accessible for review or audit for the lifetime of the record.

 

 

Definition of ALCOA Plus
Definition of ALCOA Plus

Also Read:

Best Practices to Avoid Data Integrity.

Annual Product Quality Review (APQR) in pharma

For interview preparation refer

YT channel: Pharmabeej

Leave a Comment