Principles of Data Integrity

The ALCOA-Plus Framework The ALCOA-plus framework articulates the essential attributes that data must possess to be considered reliable and...

The ALCOA-Plus Framework

The ALCOA-plus framework articulates the essential attributes that data must possess to be considered reliable and trustworthy. Data must be attributable to the individual who generated it, legible and permanently recorded, contemporaneous with the activity being documented, original or a certified true copy, and accurate, reflecting the true value observed. The extended plus attributes require that data additionally be complete, encompassing all data generated including repeat or reprocessed results; consistent, reflecting a chronologically logical sequence of events; enduring, recorded on durable media that persists throughout the required retention period; and available for review and audit throughout its lifecycle. This framework applies equally to paper-based and electronic records and underpins the regulatory expectation that quality decisions are based upon complete and reliable data.

Common Data Integrity Vulnerabilities

Data integrity vulnerabilities frequently identified during regulatory inspection include selective reporting of favourable results while suppressing unfavourable results, referred to as testing into compliance; inadequate audit trail review, whereby electronic records generated by analytical instrumentation are not systematically examined for evidence of data manipulation or deletion; shared user login credentials, which compromise the attributability of electronic records to a specific individual; and backdating or fabrication of manual records. Robust data governance requires a combination of appropriate technical controls, such as validated computer systems with active audit trail functionality, and organisational controls, including a quality culture that does not create undue pressure to produce favourable results.