ALCOA+ is the data integrity standard regulators expect labs to follow: every record should be Attributable, Legible, Contemporaneous, Original, and Accurate — plus Complete, Consistent, Enduring, and Available. Together those nine principles define what "trustworthy data" means to an FDA or ISO assessor.
The short version: if you can't show who did something, when they did it, and that the record hasn't been altered, the result doesn't count — no matter how good the science was. ALCOA+ is how you make that provable.
The nine ALCOA+ principles, in plain terms
The original ALCOA framework covered five attributes. The "+" added four more as electronic records became the norm. Here's what each one asks of a lab record.
- Attributable — you can tell who created or changed the record.
- Legible — it's readable and permanent, not a faded note or an overwritten cell.
- Contemporaneous — it was recorded when the work happened, not reconstructed later.
- Original — it's the first capture of the data, or a verified true copy.
- Accurate — it reflects what actually happened, with errors documented rather than erased.
- Complete — nothing is missing, including repeats and the reasons for changes.
- Consistent — dates, times, and sequence line up across records.
- Enduring — it survives on durable media for its full retention period.
- Available — it can be retrieved when an auditor asks.
Where paper and spreadsheets fail ALCOA+
Most data integrity findings don't come from bad science. They come from records that can't defend themselves. A shared spreadsheet fails on "attributable" the moment two people use the same login. A result typed up at the end of a shift fails "contemporaneous." A corrected value written over the original fails "original" and "accurate" at once.
These aren't edge cases. They're the everyday reality of a lab that grew faster than its recordkeeping. The fix isn't more discipline — it's a system that captures integrity automatically.
How a LIMS builds ALCOA+ into daily work
The strongest way to meet ALCOA+ is to make the right behavior the only behavior. That's what a well-configured LIMS (laboratory information management system) does: it records integrity as a side effect of doing the work, so analysts don't have to think about it.
In Confident, every entry is tied to the individual user who made it, which covers attributable. Timestamps are applied by the system at the moment of capture, not typed in, which covers contemporaneous. The original value is never overwritten — a correction is stored as a new version with the old one intact and a reason attached, which protects original and accurate. And because the audit trail can't be edited by users, complete and consistent hold up under review.
The point isn't that software makes a lab compliant on its own. That still depends on your validated SOPs and how your team works. But a system that enforces these controls removes the most common ways records go wrong.
Building an ALCOA+ culture, not just a checklist
Technology handles the mechanics. People handle the judgment. A few habits keep data integrity real rather than performative:
- Document corrections openly — a visible edit history is a strength, not an admission of failure.
- Train analysts on why a control exists, not just the click path.
- Review audit trails as part of routine QC, not only when something breaks.
- Give every user their own credentials — shared logins quietly undo attributability.
Labs that adopt this mindset tend to move faster, not slower. When the evidence is already attached to each result, review and release stop waiting on manual cross-checks.
Frequently asked questions
What does ALCOA+ stand for?
Attributable, Legible, Contemporaneous, Original, and Accurate — the original five — plus Complete, Consistent, Enduring, and Available. The nine attributes together describe what makes a lab record trustworthy to a regulator.
Is ALCOA+ a legal requirement?
ALCOA+ itself is a framework, not a law. But regulators like the FDA and standards like ISO 17025 expect the data integrity it describes, so meeting ALCOA+ is how most labs demonstrate they meet those expectations.
Can a paper-based lab meet ALCOA+?
Yes, but it's hard. Paper can be attributable and original if you're disciplined, but proving contemporaneous timing and preventing quiet edits takes constant effort. Electronic systems enforce these controls automatically, which is why regulators increasingly expect them.
How does a LIMS help with data integrity?
A LIMS ties each record to a user, applies system timestamps, versions corrections instead of overwriting them, and keeps an audit trail users can't alter. That covers most ALCOA+ principles by design rather than by memory.
Data integrity isn't a document you write once and file away. It's a property of how your lab captures every result, every day. Build the ALCOA+ principles into the system your team already uses, and passing your next data integrity audit becomes a matter of pulling a report — not rebuilding the story after the fact.
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