Data Integrity: ALCOA ++
Regulatory Definitions of Data Integrity
USFDA: “Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded original, and accurate (ALCOA)”.
MHRA: “The extent to which all data are complete, consistent, and accurate throughout the data lifecycle.”
WHO: “Data integrity is the degree to which a collection of data is complete, consistent and accurate throughout the data lifecycle. The collected data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate”.
PICS: “Data Integrity is defined as the extent to which all data are complete, consistent, and accurate, throughout the data lifecycle”.
| Attributable | The Identity of the person completing a record (Who, When, Why). |
| Legible | The data is readable, Understandable, Traceable, Permanent allowing for a clear picture of the activities that occurred. |
| Contemporaneous | The data is recorded at the time it is generated or observed (No Back dating). |
| Original | Original Records must preserve data accuracy, completeness, content and meaning. Data as the file or format in which it was initially generated. |
| Accurate | The data record must be accurate whether paper or electronic, it must be exact, true and free from error (this might require a second verification if necessary). |
| Consistent | Consistent application of date and time stamps in the expected sequence. |
| Complete | All Information needs to be maintained. Batch pass-fail, Reanalyses carried out. (OOS, OOT). |
| Enduring | Medium used to record data should be permanent and not temporary memory RAM. |
| Available | Available/Accessible for review / audit for the life time of the record. |