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Integrity by design

ALCOA+ and end-to-end traceability

Uncomfortable audit question: prove this result wasn't altered after it was signed. In a spreadsheet, the honest answer is 'we can't.' Here nobody erases what was done and you reconstruct the entire life of any record. Data integrity isn't a button you switch on, it's how the system was built: it records who did what and when, preserves history instead of deleting it, and keeps traceability from proposal to report.

What was changed is recorded, never gone.

Changing relevant data doesn't erase the past, it records the change. Who, what and when are stored for good.

The integrity principles are already in the system.

ALCOA+ isn't a poster on the wall: it lives in how each record is saved and versioned. Integrity is built into the way the data is stored, not parked in a separate checklist.

Reconstruct a sample's entire life.

Each sample carries its full history, from receipt to disposal, with a logged reason on every cancellation and disposition. From proposal to report, the chain is closed.

Each person only does what they're allowed to.

Profiles define who sees and who does what (view, create, edit, delete). Without permission, the action doesn't even exist for that user, and the inactivity lock ends the session for security.

Every action carries a name.

The result is attributable because the system knows who's logged in doing each thing. There are no orphan records with no owner, the kind auditors love to question.

Cancellation and disposal require a reason.

You can't make a sample disappear in silence. Every cancellation and disposition asks for the justification, which is logged with the record.

The trail follows the whole chain.

From proposal to sampling, from analysis to report, each link leaves a trace. You reconstruct the full path, not loose pieces that don't talk to each other.

Ever notice data integrity only gets tested when something goes wrong? Nobody asks for the audit trail of the perfect report. They ask for the one that was contested. That's why it has to be there from the first record, not switched on when the problem shows up.

What each ALCOA+ letter becomes in practice

ALCOA+ usually becomes a poster slogan. Here it's how the system stores each piece of data, and you can point to where each principle happens.

Attributable and contemporaneous.

Each record knows who did it and when, at the moment it happened. It's not someone transcribing later what they remember was done.

Original and accurate.

The logged data stays preserved, and a correction records the change instead of overwriting the original. The starting version isn't lost.

Legible and enduring.

The history stays searchable over time, not in a format nobody opens anymore. Today's record is still legible in the audit two years from now.

Frequently asked questions

Can I delete a piece of data on purpose in the system?

Relevant data isn't deleted, it's versioned. The change records who changed it, what and when, and the previous value stays preserved. The history doesn't vanish, which is exactly what the audit trail has to guarantee.

How does the system make sure each action has an owner?

Through access control by profile. Each user logs in with their own identity, and the action is attributed to whoever did it. Without permission, the action doesn't even appear for that user, so there's no orphan record.

Can I reconstruct a sample's path from start to finish?

You can. Each sample carries its history from receipt to disposal, with a logged reason on cancellations and dispositions. From proposal to report, the chain stays closed and searchable.

Is ALCOA+ a feature I turn on?

It isn't a button. It's how the system was built to store and version information. Attributable, legible, contemporaneous, original and accurate don't live in a separate checklist, they live in the way each record is saved.

Want to see the QMS running with your lab’s routine?

Get through the next audit without burning a weekend night hunting for PDFs. Book a demo and see document control, CAPA and Westgard working with a case similar to your lab's.

ALCOA+ and end-to-end traceability · Qualidade · Gerencialab