A failed check
An inspection or scheduled check that fails raises the issue itself, carrying the check reference with it.
Capture & resolve
Find it, fix it, prove it.
A problem enters once and stays in one record until it is closed. The inspection that found it, the action that answered it, the evidence attached, and the signature of the person who verified it are the same object — not four systems joined by a reference somebody typed.
LoggedISS-0847
Origin · check INS-4412
Raised automatically by the failed check
Assigned · in progressCAPA-1188
Owner · S. Ellis
Owned, with evidence attached
Pending approvalISS-0847
Verifier · J. Nash
Verification signature — not the owner
Closed—
Awaiting verification
Verification is a separate signature, by someone other than the owner
Built for 21 CFR Part 11
ISO 27001 aligned
ALCOA+ data integrity
Electronic signatures
Tamper-evident audit trail
Capture
Six ways a problem arrives. One place it lands.
Every issue records where it came from, so an auditor following a thread starts at the origin rather than at the first person who happened to type it up.
An exception
A threshold breach detected by the platform — a temperature excursion, an overdue action, a missed huddle.
An external audit
Findings logged against the audit that raised them, so the response is traceable to the source.
A customer complaint
Captured as an issue with the complaint attached, not as an email thread.
A supplier or vendor
Incoming non-conformance recorded against the supplier it came from.
A person on the floor
Raised on a phone or shared terminal in seconds, with a photograph.
Triage & routing
Severity decides the clock, not the queue.
Issues are graded Observation, Minor, Major or Critical, and categorised across People, Safety, Quality, Delivery, Cost and Sustainability. Grade and category together set the response and resolution targets and the owner it routes to.
- Separate response and resolution targets, each tracked against the clock
- A breach is flagged on the record, not discovered in a monthly report
- Routing rules assign the owner; an override has to be approved and reasoned
- Triage itself is signed, capturing who graded it and why
LoggedISS-0847
Origin · check INS-4412
Raised automatically by the failed check
Assigned · in progressCAPA-1188
Owner · S. Ellis
Owned, with evidence attached
Pending approvalISS-0847
Verifier · J. Nash
Verification signature — not the owner
Closed—
Awaiting verification
Verification is a separate signature, by someone other than the owner
Resolve
Six methods, so the response fits the problem.
Most systems offer one shape of corrective action and everything gets forced into it. Choosing the method is part of triage, and the choice is recorded.
01
Action
A single owned task. The right answer for most things, and deliberately the lightest.
02
CAPA
Corrective and preventive action where the finding needs a formal, evidenced response.
03
SRCA
Structured root cause analysis — Five Whys, with each causal chain captured and categorised separately.
04
DMAIC
Define, measure, analyse, improve, control, for problems that need the full discipline.
05
SIP
A short improvement project, sitting between an action and a full DMAIC.
06
Deviation
Recorded where the departure itself is the regulated event.
Close
The person who did the work cannot be the person who signs it off.
Closure and verification are recorded separately, by different people. This is the control auditors probe first, because it is the one most often missing.
- A Critical issue cannot even be logged without evidence attached
- Verification is a separate signature, by a different person
- Every signature carries the signer, their intent and the exact record signed
- Reopening is itself a signed, counted event
- Signer
- J. Nash · Quality Lead
- Intent
- Verified effectiveness of corrective action
- Record
- CAPA-1188 · version 4
- Signed at
- 2026-08-14 14:22:07 UTC
- Method
- Password + PIN · configurable per site
Audit entry recorded before the change
Who, what, when, and the values before and after. Added to, never edited.
Run the day →
Where open issues surface every morning, and where commitments become tracked actions.
Assure & prove →
Document control and competency — the two things an inspection tests hardest.
Compliance →
Built to support your Part 11 and Annex 11 compliance, with the controls configurable per site.