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Industries

Five sectors, one recurring question.

The standards differ. The thing an inspector does is the same: pick one item and follow it from the moment it was found to the evidence it was fixed.

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Built for 21 CFR Part 11 ISO 27001 aligned ALCOA+ data integrity Electronic signatures Tamper-evident audit trail

GMP · MHRA · EMA · FDA

Pharmaceutical

GMP manufacturing under MHRA, EMA and FDA inspection. Deviations and CAPAs are examined in detail, and ALCOA+ data integrity means a record must be attributable, legible, contemporaneous, original and accurate — and complete, consistent, enduring and available.

The risk is not that a problem occurred. It is being unable to show it was investigated and closed properly.

Deviations become tracked issues the moment they are raised, investigations carry their evidence, and every signature is bound to the record version it approved. ALCOA+ properties are enforced at entry rather than checked afterwards.

DEV-2291Batch B-4471 · fill line 2MAJOR
Deviation
Fill weight below limit, 14 units
Stage
Aseptic fill · in-process check
Raised by
L. Haddad · operator
Raised at
2026-08-14 09:41 · at the line
Batch status
Quarantined pending investigation
Recorded at the point of work
Attributable, legible, contemporaneous, original, accurate — captured on entry rather than reconstructed for the file.
Signature bound to this version of the record

ISO 13485 · FDA QSR

Medical Device

ISO 13485 and FDA quality system requirements. CAPA is the most commonly cited area in FDA observations, and the usual finding is not a missing CAPA but one closed without evidence of effectiveness.

Independent verification is the control auditors look for.

The verifier cannot be the person who did the work, and effectiveness is checked as its own step with its own evidence rather than assumed at closure.

CAPA-0912Sealing tool wear · tray sealer 3IN PROGRESS
Root cause agreedSRCA-114
Five Whys · tool not on PM schedule
Corrective action doneACT-3320
Owner · D. Okafor
Verification signed—
Verifier · P. Lund · not the owner
Effectiveness checks30/60/90
30-day passed · 60-day due · each signed separately
Closed and proven effective are two separate claims

BRCGS · IFS · HACCP

Food & Beverage

BRCGS, IFS and HACCP, with unannounced audits and retailer audits on top of the regulator. Corrective actions must be demonstrably closed, and traceability has to hold up under time pressure during a recall.

An unannounced audit removes the week you would normally spend preparing.

Checks are signed as they are completed, so the record is current rather than assembled. Traceability runs from a single finding through to the evidence it was resolved, which is the path an auditor follows.

CCP-03Metal detection · line 4 · 14:00 checkSIGNED
Critical limit
Fe 2.0 mm · non-Fe 2.5 mm · SS 3.0 mm
Test pieces
All three detected and rejected
Reject check
Bin locked, alarm confirmed
Completed by
R. Ferreira · 14:06
Signed at
14:06 — as completed, not later
06:00
pass
10:00
pass
14:00
pass
18:00
due
22:00
—
An unannounced audit sees the same record you do

ISO 9001 · ISO 45001

Industrial & Engineering

ISO 9001 and ISO 45001, multi-site operations, and safety incidents where the investigation trail matters as much as the fix.

Recurrence is the measure that gets scrutinised: the same problem twice is evidence the corrective action never worked.

Recurrence is tracked against the original issue rather than logged as something new, and multi-site records share one identity and audit format so a group-level question has a single answer.

ISS-1330Guard interlock bypassed · press 2RECURRENCE
Original
ISS-0884 · same asset, same cause
First raised
2026-02-19
Closed
2026-03-04 · verified by shift lead
Recurred
2026-08-11 · 160 days later
Sites affected
2 of 4 · same press model
Linked to the original, not logged as new
The same problem twice is evidence the corrective action never worked — so it is counted against the first one.
One identity and one audit format across every site

GDP · BRCGS S&D · IFS Logistics · ADR

Logistics & Distribution

EU GDP for medicinal products, BRCGS Storage & Distribution and IFS Logistics for food, ADR for dangerous goods — and on top of the regulator, the customer’s own auditor, often at short notice. A temperature excursion, a broken seal or a damaged load has to be shown as found, decided and closed, not noted on a delivery sheet.

A retailer audit picks one consignment and follows it from the dock to the decision.

Dock and trailer checks are signed as they are completed, so a failed seal or an excursion becomes an issue with a named owner the moment it is found. The reading, the decision taken and the carrier follow-up sit on the same record, and recurrence by carrier is measured — so the third damaged load from the same haulier is evidence rather than a feeling.

INS-7731Inbound trailer check · bay 4 · 06:40EXCURSION
Load
Carrier ref C-118 · trailer 2281 · chilled
Seal
Matches manifest · 004417
Temp at door
9.4 °C · limit 2–8 °C
Decision
Load held · QA notified · ISS-1318 raised
Raised by
M. Okafor · dock operator
Signed at
06:44 — at the dock, not the office
Linked to earlier issues
Third excursion on this route in 60 days. ISS-1290 and ISS-1302 are attached, so the carrier review has its evidence.
The retailer’s auditor follows the same record you do

An inbound check that failed on temperature. The excursion is an owned issue within minutes, and the carrier’s history is attached to it.

Example uses

Fourteen things that go wrong, and how each one looks in the record.

The problems inspectors write up most often in each sector, taken from published inspection data. Each one is shown the way it would look in OpenAcura: a deviation that cannot close without a cause, a CAPA that was closed but not proven, a trailer that warmed up on the M6, a guard bypassed at two sites.

See the fourteen examples

See it against your own process.

Half an hour, your scenarios, no slides. If it is not a fit, we will say so.

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