“Was this operator qualified on the eleventh?”
Assessments are dated and signed, so qualification for a past shift is a record you retrieve rather than a recollection you offer.
Assure & prove
Audit ready — all the time.
Two things decide how an inspection goes: whether your controlled documents are current and provably approved, and whether you can show that the person doing the work was qualified to do it — not today, but on the day it happened.
- 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.
Built for 21 CFR Part 11
ISO 27001 aligned
ALCOA+ data integrity
Electronic signatures
Tamper-evident audit trail
The question that gets asked
Current status is easy. Historic status is the audit.
Any system can tell you who is qualified today and which procedure is in force now. A spreadsheet holds one state — the present one. The questions that produce findings are about a date in the past.
“Which version of this procedure were they working to?”
Superseded versions are retained with their effective dates, so the answer is the document itself rather than an inference from a change log.
Competency
Four states, because a blank cell reads as unknown.
Competency is held per person, per task, as a matrix. Each cell carries its status, when it was last assessed, and when it expires.
Valid
Assessed, in date, and evidenced.
Expiring
Inside thirty days of expiry, so it appears on a plan rather than on an audit finding.
Expired
Past its date. Visible as a gap, not hidden by a green cell.
Not competent
Assessed and not passed — a deliberate state rather than a blank.
61
Level 3 — Standardised
Defined practices and routines, with a lot still moving between them by hand
Defined practices and routines, with a lot still moving between them by hand
42Connected index — Fragmented. The practices are stronger than the connections between them.
Evidence & risk
Graded by consequence, evidenced five ways.
Not every task carries the same risk, so not every task needs the same weight of proof. Tasks are graded from low through to GxP-critical, and the evidence required scales with the grade.
- A certificate
- A record from your training system
- A signed quality record
- An attestation from a named mentor
- An observed validation run
Assessments for the tasks that matter most are signed off by a named subject-matter expert, and expiry inside thirty days surfaces as something to plan rather than something to explain.
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
Document control
Four stages, and nothing is deleted.
Controlled procedures and work instructions move through a fixed lifecycle. Every transition is signed, and superseded versions are retained.
01
Draft
Being written. Not available to the floor.
02
In review
With named reviewers and approvers. Each decision is signed, and a reviewer declining is recorded as plainly as one approving.
03
Approved
In force. Distributed to the roles that need it, with acknowledgement required where it matters.
04
Superseded
Replaced but not deleted, so the version that was in force on a past date can still be produced.
Read-and-understood
A distribution list is not evidence that anybody read it.
Documents can be mapped to the roles that must be trained on them, so a new procedure automatically becomes a requirement for the right people rather than a message somebody has to remember to send. Where acknowledgement is required it is signed by each person individually, and the outstanding list is visible while it still matters.