The approval lives in a mail thread
The SOP is in one folder, the comments are in Outlook, and the signed PDF is somewhere else. Nobody can see where it stands.
eQMS for life science teams of 5–30 people
Get your quality system out of Word.
QENTRA is an eQMS built by QA practitioners for small pharma, biotech and medtech companies. SOPs, deviations, CAPAs and training in one place, with the review discussion inside the record instead of in your inbox.
DEV-2026-014
Draft
Temperature excursion, cold room 2
- Classification
- Minor
- Linked CAPA
- CAPA-2026-006
- Owner
- QA Lead
- Due
- 14 Oct 2026
Discussion in this record
QP
External QP · guest reviewer
Please attach the data logger export before I sign.
QA
QA Lead
Attached: logger_CR2_export.pdf
Awaiting review · audit trail on
EU GMPGDPISO 13485EU MDR21 CFR Part 11EU GMP Annex 11GAMP 5ISO 9001GDPR
The problem
Does this sound like your quality system?
Most small life science companies start with documents and spreadsheets. It works until the first inspection, the first partner audit or the first investor due diligence.
The CAPA tracker is one person's spreadsheet
Due dates slip because reminders depend on someone remembering to open the file.
Your external QP or consultant signs by email
They review a copy, reply with comments, and you merge it back by hand. The context gets lost on the way.
An audit means days of finding things
Training records, document versions and CAPA evidence have to be pulled together from five places before anyone can answer a question.
Compliance without complexity
One connected flow, from event to closure.
Every step lives in the same record, with its audit trail, signatures and discussion attached. Nothing to copy between systems.
- 1
Deviation
Logged and classified in minutes
- 2
Investigation
Root cause with evidence
- 3
CAPA
Actions, owners and due dates
- 4
Effectiveness
Checked and signed by QA
- ✓
Closed
Inspection-ready, with full trail
Word, Excel and email
- Cheap to start
- No audit trail or e-signatures
- Status depends on people
- Hard to show an inspector
Enterprise eQMS
- Complete and proven
- Priced and scoped for larger companies
- Long implementation
- Many modules you don't need yet
QENTRA
- Sized for 5–30 people
- Audit trail and e-signatures built in
- Review and discussion inside the record
- Onboarding, templates and validation included
Beta 1
What's inside
The core workflows a small regulated team runs every week, connected to each other.
Document control
Versioned SOPs and forms with review, approval and e-signature.
Deviations
Log, classify and investigate, and link straight to a CAPA.
CAPA
Root cause, action plan and effectiveness check, with QA gates at each step.
Training (Read & Understood)
Staff confirm new SOP versions with an e-signature.
External review & approval
Your QP, consultant or CDMO reviews and signs in the record, without a full licence.
Audit indicators
See open deviations, overdue CAPAs and pending approvals at a glance.
On the roadmap: full training management, audit management and supplier management. We say this upfront so there are no surprises.
Trust
Built for regulated work from day one
A small vendor has to earn your trust. Here is what we commit to.
Validation package
Documentation following a GAMP 5 approach, included from Beta 1 launch.
Audit trail and e-signatures
Designed with 21 CFR Part 11 and EU GMP Annex 11 in mind.
Your data, under a DPA
A data processing agreement as standard, with hosting that meets EU data protection requirements.
Migration and templates
We help move your existing documents and give you QMS templates to start from.
Built by QA practitioners
Designed by people who have run deviations, CAPAs and inspections in a GMP environment, for small teams that need a real quality system without the enterprise overhead.
Founding Partner programme
Build your quality system with us
We're opening a small number of places for companies that want QENTRA from the start and want a say in how it grows.
3–5places at Beta 1 launch
What you get
- A founding discount, locked in permanently on Beta 1 scope
- Onboarding, QMS templates, validation package and document migration included
- Direct access to the team building it, not a sales team
- Real influence on the roadmap through structured feedback
- No multi-year lock-in
It's a good fit if
- You're a pharma, biotech or medtech company with 5–30 people in the Nordics or DACH
- Your QMS runs on Word, Excel, SharePoint or email today
- Someone owns quality and can give it time in the first weeks
- You want to help shape the product
How it starts
- 01 · Now
A 20-minute call
We talk about how you run quality today. No pitch and no demo. You get a summary of what other small teams tell us.
- 02 · January 2027
Prototype demo
A walkthrough of your own workflow in the working prototype.
- 03 · Q1 2027
Founding Partner onboarding
Workspace set up, first records created, and a feedback session after month one.
Get in touch
Let's talk about your quality system
Pick a time that suits you, or leave your details and we'll get back to you within two working days.
Book a 20-min callOr email info@qentraqms.com
FAQ
Questions
Can we use QENTRA today?
Not yet. The product is in build. Prototype demos start in January 2027 and Beta 1 is planned for Q1 2027. Talking to us now puts you first in line.
What will it cost?
Pricing is published at Beta 1 launch. It is set for small teams, with onboarding, templates and validation included. Founding Partners get a permanent discount.
Is it validated?
A validation package following a GAMP 5 approach comes with Beta 1. You receive the documentation to support your own computerised system validation.
Can we bring our existing SOPs?
Yes. Document migration is part of onboarding.
Is the 20-minute call a sales call?
No. It's a conversation about how you work today. We use what we learn to build the right product.