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what is ALCOA+?

framework ensuring data integrity in industries

what does ALCOA stand for?

• attributable : identifies who performed the action

• legible: data is readable and permanent

• contemporaneous: recorded at the time of the action

• original: first recorded version, not copied

• accurate: correct and free of errors

what does the + stand include?

• complete: includes all data, including changes

• consistent: must show a clear timeline of actions without gaps or errors

• enduring: it should remain intact and unaltered over time

• available: easily accessible for audits or reviews

3 types of actions CAPA

• immediate action/correction

• corrective

• preventive

immediate action/correction

action taken to quickly fix the impact of the problem

corrective action

action taken to eliminate the error

preventive

action taken to prevent the error from recurring

EC

• who will look at what data?

• how long after the action plan will this be done?

• what criteria in the data results will determine that the problem has not recurred

problem solving process

1. identify problem statement

2. identify team

3. immediate action

4. identify root cause

5. proposed CAPA

6. implement CAPA

7. proposed EC

8. implement EC