Compliance assessment
Where your quality system stands against a standard, clause by clause, and the page in your own documents behind every answer.
21 CFR 4 · 210 · 211 · ISO 13485Inside the moduleASSESSMENT · TRAINING · DOCUMENT CONTROL · LIFE SCIENCESREV 2026.10
No quality professional should start from a blank page again.
Compliance status assessment of your QMS, and a complete training management solution
A WORKING SYSTEM · WALKED THROUGH BY A FOUNDER · A REPLY IN 2 TO 3 BUSINESS DAYS
- ·01ADMIN · TRAINING
- A training built from one document version, with its source beside it.
- ·02ADMIN · COMPLIANCE
- One standard, read clause by clause against the whole library.
- ·03TRAINEE · LESSON
- A lesson, beside the page of the document it rests on.
REV2026.10
SHEET1 OF 1
SCALENTS
What it does today
Four modules on one core. Pick the ones you need: each reads what the others hold. What follows is what exists, stated exactly.
Self-assessment
Your library read against the rules it sets itself, and every place two of your own documents require different things.
YOUR OWN PROCEDURESInside the moduleGxP training
Training built from your controlled documents, signed under Part 11 at completion, and reassigned when a document changes.
21 CFR PART 11Inside the moduleDocument control
Every revision as a numbered change: checked before review, signed off by class, and in force at the last signature.
DRAFT · REVIEW · IN FORCEInside the moduleThe old “read and understood” rarely carried the learning it needed
REVISION3.14.0
DOCUMENTSOP-014
AFFECTEDEVERYONE ON 3.1
- ·01BY HAND
- A revision lands. Someone opens a spreadsheet, works out who trained on the old version, and reassigns them by hand.
- ·02FROM MEMORY
- Then they try to remember which roles require which documents, and on what interval.
- ·03THE COST
- At a hundred-person site that housekeeping can consume up to half a QA specialist's time. It is entirely mechanical work, and it is exactly the part an inspector will ask you to prove.
THE FIGURE IS THE INDUSTRY'S. WHAT FOLLOWS IS OURS.
EVIDENCE ON HANDREV 2026.10
An inspector asks four questions
Not a report you assemble the week before. The answers are a by-product of how the training was built in the first place.
Which version did she train on?
Every training is bound to one source file version, and the completion record names it.
- EVIDENCE
- v3.2.0
Show me the signature.
Signer, timestamp, meaning, and the re-authentication behind it. In the export and at a verify endpoint.
- EVIDENCE
- GET /verify
Who in QC is overdue on SOP-014?
The qualification matrix answers by group, with a status per person and a drill-down.
- EVIDENCE
- MATRIX
Show me the trail.
Written with every change, with its reason and what it was before and after. Each entry is chained to the last by its hash, so an edited one shows. Export as PDF or CSV.
- EVIDENCE
- HASH-CHAINED
NOTE
FOR IT, CSV AND SECURITY REVIEWHosting, authentication, tenant isolation, data handling, and the nine compliance documents written by neolumi.SECURITY →Where these answers come from
Nothing above is assembled the week before. Each answer is a record the system wrote at the time: when the training was generated, when it was completed, when it was signed, when the revision reassigned it.
Export the set as PDF or CSV on the day it is asked for.
- RECORDED
- AT THE TIME
DEMO REQUESTREV 2026.10
Book a demo
It goes to a person, not a queue. Bring an SOP you dread revising and we will run it through in front of you.