Building a Data Integrity Culture

Good Documentation / Data Practices 

Good documentation and data practices extend from paper records into electronic records and management of both.  Data Integrity has at its foundation quality data and an understanding of how the data is used to support GxP activites.  A common definition of quality data includes data that meets the principles of ALCOA or its extension ALCOA Plus.  

ALCOA

Attributable:

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:

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 recorded at the time they are generated or observed.

Original:

the first or source capture of data or information and all subsequent data required to fully reconstruct the conduct of the GXP activity.

Accurate:

Data are correct, truthful, complete, valid and reliable

Plus (+)

The plus component of ALCOA adds the following intrinsic principles:

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.