Layer 2 · Record verification

Your procedure says it. The record has to show it.

Aligntra reads the procedure that governs a record, takes the requirements out of it, and checks the record against them. Not against the standard. Against what you wrote down.

See it on the example QMS How the full review works

The situation

A gap analysis grades your documents. An audit grades your evidence. The second needs your procedures read first, because the yardstick for a record is the procedure that governs it.

One run, two readings

The yardstick changes with the document

Both readings happen in the same run, on the same upload. A procedure is measured against the standard; a record is measured against the procedure that governs it.

The standard Corrective action the clause you are audited against

Layer 1 Does it say what is required?

Your procedure CAPA SOP QP-014 rev 6

Layer 2 Did it happen that way?

Your record CAPA record CAPA-2026-0184

The standard governs the procedure. The procedure governs the record. A CAPA record is measured against QP-014, which your organisation wrote and can revise; the standard sets what QP-014 has to cover.

Method

How a record is verified

Four steps, and the order is the reason it works. The procedure is read before the record, so the yardstick comes from you rather than from us.

The requirements come out of your SOP

The governing procedure is read first, and the obligations it places on a record are extracted: the fields, the approvals, the sequence, the deadlines.

The facts come out of the record

Dates, owners, decisions, references, and what each one is attached to.

Each requirement gets its own verdict

Pass, fail, partial or not applicable, with the reasoning and a verbatim quote from the record as the evidence.

The quote is highlighted in the source PDF

Click a finding and land on the page it was drawn from, in the record itself.

One requirement, end to end

What a verified requirement looks like

The left side is your procedure. The right side is your record. The finding is the distance between them.

REQ-QP014-5.3 Effectiveness verification tests the identified failure mode Minor NC

What your procedure requires

QP-014 rev 6 · §5.3 · page 7

Effectiveness verification shall test the failure mode identified in the root cause analysis, using a sample drawn after the corrective action was implemented.

Extracted from QP-014 alongside 13 other requirements the procedure places on a CAPA record.

What the record shows

CAPA-2026-0184 · §7 · page 4

“Effectiveness verified 12 Mar 2026. Reviewed 30 lots from January and February 2026 production; no recurrence of the defect observed.”

The corrective action was implemented 28 Feb 2026, recorded in section 6 of this same record. Twenty-eight of the thirty lots in the sample were produced before that date, so the check does not test the action that was taken.

Ask on the day: Which lots in the effectiveness sample were produced after 28 February 2026?

Illustrative. Each element shown is one the product returns for a verified requirement: the requirement with its source, the verdict, the verbatim quote, the reasoning and the question to ask. Nothing here is missing from the record. It is complete, signed, and wrong. Grading that record against a clause has nothing to compare the two dates with.

The difference

Findings that need the procedure first

These are questions about a record, and none can be asked until the governing procedure has been read. In each case the record looks complete. It is the relationship between its parts that fails.

Coherence

An action that does not follow from its own root cause

The record names a cause and takes an action. Neither field is empty, and the action does not address the cause.

Coherence

An effectiveness check that tests the wrong thing

Verification was performed and signed. It does not test the action that was taken, or it samples from before the change.

Timeline

A milestone closed after your own deadline

The dates are complete. One of them is later than the interval your procedure sets for that phase.

Completeness

An approval your procedure requires and the record omits

Read against the standard, the record is fine. Read against QP-014, a named signature is absent.

Sequence

A phase the record skipped

Your procedure defines a phase order. The record moved to containment without the interim assessment that is supposed to precede it.

Log health

The pattern across the whole log

Records that stall at the same phase, or a recurring root cause across separate CAPAs that were each closed on their own terms.

The record out

It leaves in the audit file

Record verification adds its own sheets to the audit workbook, beside coverage and findings. Each row keeps the citation and the reviewer decision, and the workbook stands on its own without access to Aligntra.

Audit workbook · record verification sheets

CAPA

Timeline Verification Coherence Checks CAPA Log Health Findings by Phase

NCR

Disposition & Classification Investigation Detail

What record verification covers

CAPA and NCR records. Each one is read against the procedure your organisation wrote to govern it.

Any other document in the run is read as a procedure, against the standard. A deviation procedure is assessed against its applicable clauses like any other document; the deviation records produced under it are not verified against it.

See it on the example QMS

Open the Records tab and pick any finding to see the requirement, the verdict and the quote it was drawn from.

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