Bound to the version
Training is generated from one exact source file version and stays tied to it. Each lesson highlights the passage it rests on, and the completion record names the version.
SEMANTIC FILE VERSIONINGCOMPLIANCE ASSESSMENT · GXP TRAINING · 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
Two modules today: an assessment of where your quality system stands, and the training that keeps your people qualified to it. What follows is what exists, stated exactly.
Signed under Part 11
Re-authentication at completion, then name, timestamp and the meaning of the signature. Written to a log whose role holds INSERT and nothing else.
21 CFR PART 11Requalified with ease
A revision reassigns everyone who trained on the old version. Interval rules re-qualify on schedule. One nightly job runs both, idempotently.
NIGHTLY, IDEMPOTENTThe 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.
Inside the training module
One training, taken apart. A controlled document becomes an assessment, what was missed comes back round, and the whole thing rolls up into a qualification.
- ·01Document sync
- SharePoint and Veeva Vault keep owning the controlled document. Credentials are encrypted AES-256-GCM.
- ·02Five question types
- Multiple choice, true/false, fill-in-blank, AI-graded short answer, ordered steps.
- ·03Retry to mastery
- Missed questions return in a retry queue until they are answered correctly. Two passes, one outcome.
- ·04Qualification matrix
- Role-based curricula, one-time or recurring, with a status per person and a drill-down by group.
Inside the assessment module
Where your quality system stands against a standard, clause by clause, and the page in your own documents behind every answer.
- ·01The standard, clause by clause
- 21 CFR Parts 4, 210 and 211 and ISO 13485:2016, each broken into its clauses and kept by neolumi. Your team starts from the standard, not a spreadsheet.
- ·02Read against everything
- Each clause is read against your whole document library and judged covered, partial, gap or not applicable.
- ·03Cited to the page
- A finding quotes the passage it rests on, located in the document and page it came from. A quote that cannot be found there does not stand.
- ·04Your reviewer decides
- Your quality team confirms or corrects each finding, and a correction carries its reason. Export the register as PDF or CSV.
STANDARD21 CFR 211
READ AGAINSTWHOLE LIBRARY
EXPORTPDF · CSV
- 211.25COVERED
- Personnel qualifications. Training in each person’s own operations and in current GMP is required, and a record of it is kept.CITED · SOP-TRN-002 · P.3
- 211.100PARTIAL
- Written procedures; deviations. Production and process control procedures exist, but none requires a deviation from them to be recorded and justified.CITED · SOP-PRD-005 · P.2
- 211.192GAP
- Production record review. Nothing in the library requires an unexplained discrepancy to be investigated before a batch is released.
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.
An append-only log across every route. The writing role holds INSERT and nothing else. Export as PDF or CSV.
- EVIDENCE
- INSERT ONLY
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
About us
Built by people who lived the problem.
In regulated life sciences, compliance with standards and regulatory requirements is not optional, and neither is training. Assessing where compliance stands has always been a tedious, time-consuming task. The same goes for training, where every SOP revision can mean a large retraining burden or a risk of nonconformance. A significant part of the quality team's time is spent on work that should never have been done by hand.
neolumi was founded to fix that. We build AI tools that eliminate the manual busywork of GxP compliance, so quality teams can stay inspection-ready without drowning in paperwork.
Alex Yue, MBA
CO-FOUNDERAlex built his career in life sciences, where quality decides whether a product reaches a patient at all. In these most regulatory-demanding environments, he built and maintained the quality management systems that help companies produce implantable medical devices, biologics, and small-molecule pharmaceuticals including sterile injectables and radiopharmaceuticals. As head of quality for multiple companies, he led inspections by the FDA, EMA, TGA, PMDA and NMPA, and by notified bodies such as BSI and TÜV SÜD.
As a BSI-certified QMS Lead Auditor and a quality leader, he has seen compliance from both the operational and the audit side, including the industry’s open secret: the “read and understood” signature that documents training without ever delivering the learning. That experience shaped his conviction that compliance training has to build genuine competence, not just the paperwork that proves it happened.
With an Executive Master in Change from INSEAD and an MBA from the University of New South Wales, Alex pairs deep regulatory experience with the commercial and organizational perspective to scale neolumi where compliance pressure is greatest.
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.