Guide
ALCOA+ from the bench: what each letter asks of your hands
Published October 25, 2026
ALCOA+ appears in your procedures and in your sponsors' questionnaires. At the hood, nobody knows which letter is at stake at which moment, or what the technician should do differently.
This page goes through the nine letters one at a time. For each: what the action must satisfy, then what our site states, then the limit. It does not replace your validation or your procedures.
Where the nine letters come from
The FDA data integrity guidance (December 2018) lists five attributes: attributable, legible, recorded at the time of the action, original (or a true copy) and accurate. The MHRA GxP guidance (March 2018) takes those five and adds four expectations: complete, consistent, enduring, available. The MHRA states that expectations are the same whether you say ALCOA or ALCOA+.
One limit: the FDA guidance addresses CGMP, the MHRA guidance addresses "GxP". For a study under GLP, the text that applies depends on your framework and your sponsor.
A for attributable: who did this step
The action: one identified person, one account per person. The FDA rules out shared logins, because the action can no longer be tied to an individual.
What we state: each step is signed by the authenticated operator, at the time of execution, with the reagent lot and equipment used (§11.50).
The limit: a signature ties a person to a declaration. It does not say the action was done well.
C for contemporaneous: when it happens
The action: write it down now, not in the evening. The MHRA also asks to avoid bundling several operations into one save, and to keep the delay before recording short.
What we state: nothing is re-entered in the evening. The workstation keeps recording without a network and resynchronizes on its own. The release notes state that the reception time of steps is set by the server.
The limit: a recording time is not an action time. How an offline workstation's clock behaves belongs in your validation.
L for legible, O for original
For the MHRA, legible means legible and permanent. A correction must leave the original value visible. Original means the first capture, or a true copy.
The action: the first trace is the one made at the workstation. The scrap of paper or the glove, copied out afterwards, is not the original.
What we state: steps are recorded while they are being performed. The audit trail is append-only, timestamped and SHA-256 hash-chained, so alteration shows.
The limit: the site does not speak about legibility as such, and it does not say how instrument files are attached. Both are questions to ask.
A for accurate
The action: the lot, the equipment and the values written down are the ones actually used. Every deviation is declared, not smoothed over.
What we state: lot and equipment are recorded at the step. The release notes describe a declared deviation with its category, and a step that can require a photo: until it is attached, validation is refused.
The limit: a record cannot know whether the pipetted volume was right. Accuracy goes through quality assurance review.
The four "+": complete, consistent, enduring, available
Complete: the whole study, failures and deviations included. Our site describes an Audit Pack with protocol, signatures, deviations and audit trail. Sealing starts when the sample is received and stops when the result is delivered.
Consistent: records do not contradict each other. The site describes one chain, from sample to deliverable. The release notes state that the audit trail displays time in UTC.
Enduring: the data holds for its whole retention period. The site says nothing about retention length or long-term archiving.
Available: readable at inspection. The Audit Pack is exported in one click and can be verified by the sponsor and the inspector.
What we do not say
We do not say Biotraxion covers all nine letters on its own. The site states attributable and contemporaneous data, in the spirit of ALCOA+, and a signature at every step. The rest depends on your procedures, on training, and on the validation of your computerized system, which remains each organization's responsibility.
The signature itself is covered in the guide on signatures and Part 11.
Six questions for any system
- Can you be sure who performed each step, with no shared account?
- What is legible and permanent in the export?
- Which time counts, and what happens offline?
- Where is the first trace, and what happens to a correction?
- Do deviations and failures appear in the file?
- How long does the data stay readable, and who can reread it?
See which letter costs you most
We show a sample Audit Pack and go through where your current records lose the trail: contact@biotraxion.com, or request a pilot from the home page.