The paper era of quality is closing.
Axon eQMS Suite unifies deviation, CAPA, change control, controlled documents and validation on one cryptographic audit trail.
- 21 CFR Part 11
- EU GMP Annex 11
- Annex 15
- ICH Q9 / Q10
- GAMP 5
Designed to support the requirements above; this is not a certificate or an approval.
See the product on real screens.
Protocol execution with live OOS detection
- Min/Max tolerance
- RSD
- Change history
The golden thread: from a deviation to re-validation.
Problems get lost where records don't know about each other. Axon ties every step to the one before it.
Illustrative scenario: temperature deviation on a vial filling machine
Start the flow or click a step to inspect its record.
Audit chain
SHA-256- DEV-2026-081········
- CAPA-104········
- CC-042········
- SOP-PROD-12 r4········
- OQ-VF-017········
SHA-256 is computed in your browser. For demonstration only.
One platform, many modules.
Each module can run on its own; used together, records link to each other. New modules are being added step by step.
Paperless validation and process qualification for regulated sites
Take equipment, process, cleaning and analytical-method validation protocols out of Word. Execute them with cell-level tolerance checks, live OOS detection and automatic statistics (RSD, Cp, Cpk).
- Dynamic data grid with instant OOS detection. Catches out-of-tolerance measurements (e.g. 5.800 g > upper limit 5.7159 g) with a red outline the moment they are entered, stopping the error at source.
- Automatic statistics engine. Produces mean, min, max and relative standard deviation (RSD) live from defined formulas, no calculator needed.
- Cleaning validation and residue limits. Manages MACO, swab and rinse test analyses with an integrated limit calculator on one screen.
- Template and formula engine. Word/PDF import, bulk field definition across 40+ cells, cell-level limits, role-based access and formulas such as =AVG() and =RSD().
- Regulatory focus
- EU GMP Annex 1521 CFR Part 11GAMP 5 (2nd ed.)
- Who it is for
- Validation managers, process engineers, qualification teams (IQ/OQ/PQ)
Illustrative interface rendering. Real screens and recordings live on the module pages.
The shared backbone that feeds every module.
Signatures, audit trail and multi-site structure work the same way in every module.
Universal electronic signature
Instant identity re-authentication on approvals, reviews and authoring, signature meaning (author, reviewer, approver) and segregation-of-duties checks.
Append-only audit trail
A record book protected by PostgreSQL triggers that nobody, system administrators included, can change or delete (WORM), with a SHA-256 chain. The reason for change is captured, and records can be exported as signed PDF/A and raw JSON.
Multi-site isolation
Bring your Istanbul, Ankara and European sites onto one screen; separate corporate quality rules from site-specific operations.
The 21 CFR Part 11 e-signature flow
Pick the signature meaning, re-authenticate, and the signature is bound to the record by a digest.
SOP-PROD-12, rev. 4.0: Vial filling line operating procedure
Illustrative simulation. The password you type is never sent or stored.
Try the audit trail yourself.
Pick a module and perform an action. Every row joins the chain through a real SHA-256 computation that includes the digest of the previous row.
Module
Action DV-PV-2026-0010
| # | UTC time | User | Action | Record | Previous → new | Digest (SHA-256) |
|---|---|---|---|---|---|---|
| No entries yet. Pick an action above. | ||||||
Illustrative simulation. Runs only in your browser; no data is sent or stored.
From disconnected tools to one system.
Most quality teams work in five different places today.
| Scattered approach | Axon | |
|---|---|---|
| Documents | SharePoint and paper binders | Controlled lifecycle, read-and-sign tasks |
| Deviation and CAPA | Separate software or Excel | Direct link from deviation to CAPA |
| Change control | Email chains | Impact matrix and locked closure |
| Validation | Word and Excel printouts | Protocol execution with live tolerances |
| Signature | Wet ink, scanned pages | E-signature with identity re-authentication |
| Audit trail | Different per system, hard to combine | One append-only SHA-256 chain |
Documents
SharePoint and paper binders
Controlled lifecycle, read-and-sign tasks
Deviation and CAPA
Separate software or Excel
Direct link from deviation to CAPA
Change control
Email chains
Impact matrix and locked closure
Validation
Word and Excel printouts
Protocol execution with live tolerances
Signature
Wet ink, scanned pages
E-signature with identity re-authentication
Audit trail
Different per system, hard to combine
One append-only SHA-256 chain
It can run at your own site.
Your data does not have to sit in a public cloud. On-premise or air-gapped installs keep the quality infrastructure under your control.
On-premise
On your own servers, with your own identity provider.
Air-gapped
An install option for networks without internet access.
GCP demo environment
A data-free demo instance that spins up quickly for evaluation.
Frequently asked
Does Axon make me compliant automatically?
No. Axon is designed to support the technical controls of the relevant regulations (such as 21 CFR Part 11 and EU GMP Annex 11). Compliance is achieved together with validation of the system at your site, your procedures and your organization. We make no claim of FDA approval or certification.
Do I have to buy all modules together?
No. Modules can be evaluated separately. When used together, cross-record links (deviation → CAPA → change → SOP → validation) come into play.
What are the deployment options?
On-premise, air-gapped and a GCP demo environment for evaluation. We settle together in the demo call which one fits.
Can I use my existing Word protocols?
Yes. The template editor imports .docx files and you can define input fields on table cells in bulk.
What do the AI features do with my data?
Which data goes to which service provider depends on the deployment model and is clarified during the demo. Every AI request is written to the audit trail with the model, input summary and engine version.
Does the demo contain my real data?
No. The demo environment runs on illustrative data. An install that works with your real data is set separately and by contract.
Make audit day an ordinary day.
In a short demo we look at your own use case together.