DATA INTEGRITY: ALCOA AND ALCOA PLUS
||Attributable means information is captured in the record so that it is uniquely identified as executed by the originator of the data (e.g. a person or a computer system).|
|The terms legible and traceable and permanent refer to the requirements that data are readable, understandable, and allow a clear picture of the sequencing of steps or events in the record so that all GXP activities conducted can be fully reconstructed by the people reviewing these records at any point during the records retention period set by the applicable GXP.|
||Contemporaneous data are data recorded at the time they are generated or observed.|
||Original data include the first or source capture of data or information and all subsequent data required to fully reconstruct the conduct of the GXP activity.
The GXP requirements for original data include the following:
• original data should be reviewed;
• original data and/or true and verified copies that preserve the content and meaning of the original data should be retained;
• as such, original records should be complete, enduring and readily retrievable and readable throughout the records retention period.
|Accurate||The term “accurate” means data are correct, truthful, complete, valid and reliable.|
|ALCOA PLUS (ALCOA +)|
||All data are available, nothing has been deleted (evidence: audit trail).|
|CONSISTENT||Data are recorded chronologically with data and time (evidence: audit trail).|
||Data are accessible for an extended period of time – after 20 years.|
|AVAILABLE||Data are accessible over the lifetime of the product.|