An ALCOA+ Checklist for the Shop Floor

ALCOA+ is the acronym for the core principles that define the reliability of GMP records. Knowing the principles by heart is easy; the real question is whether they are applied on the floor. The questions below help you get a quick picture of compliance during a half-hour walk through a production line or laboratory.

A — Attributable

• Is it clear who made each record and when?
• Are there shared user accounts or shared passwords?

L — Legible

• Are handwritten records legible, and are corrections made with a single line, justified and signed?
• Will records remain readable throughout the retention period?

C — Contemporaneous

• Are records made at the time of the activity, or filled in all at once at the end of the shift?
• Are system clocks correct and protected from user changes?

O — Original

• Is the raw data (first record) preserved? Are there temporary notes on scraps of paper?
• Are original data and metadata retained in electronic systems?

A — Accurate

• Have calculations and data transfers been verified?
• Are instruments calibrated and systems validated?

+ Complete, Consistent, Enduring, Available

• Are all data recorded, including repeated analyses and failing results?
• Are the sequence of records and time stamps consistent?
• Have backup and restore been tested?
• Can a record requested during an inspection be found within a reasonable time?

Every question on this list that you answer with "no" or "not sure" is a starting point for a data integrity risk assessment.