ALCOA

 

TERM DEFINITION
Attributable

 

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).

 

Legible, traceable

And permanent

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

 

Contemporaneous data are data recorded at the time they are generated or observed.

 

Original

 

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 +)

 

TERM DEFINITION
COMPLETE

 

All data are available, nothing has been deleted (evidence: audit trail).

 

CONSISTENT Data are recorded chronologically with data and time (evidence: audit trail).

 

ENDURING

 

Data are accessible for an extended period of time – after 20 years.

 

AVAILABLE Data are accessible over the lifetime of the product.