Your trial records, under your control.
ZINOS is your hospital's own system, with audit trails, signatures, and version history built in.
The standards ZINOS answers to.
- ICH GCP
- 21 CFR Part 11
- EMA Annex 11
- ALCOA+
Built-in controls map to each ALCOA+ principle.
You answer for the systems you use.
- ICH E6(R3): applies in the EU from 23 July 2025Sourceema.europa.eu
- ICH E6(R3): the site should control the essential records it generatesSourcedatabase.ich.org, ICH E6(R3) Step 4, 6 January 2025
- EMA guideline: whoever is responsible for a system ensures its validationSourceema.europa.eu
- EMA guideline: the sponsor should not have exclusive control of site dataSourceema.europa.eu
Every change, attributed and kept.
Audit trail: one document's full history
- Informed consent form, visit 3
- Record 0417
- Changed by
- A. Novak, study coordinator
- When
- 14 Sep 2026, 09:42:17 CET
- Value
- Version 4.1
- Version 4.2
- Reason
- Protocol amendment 3
- Signed
- A. Novak · 09:43:02 · Author
- Audit trail
- 09:43:02 Signed A. Novak
- 09:42:17 Changed 4.1 to 4.2
- 02 Sep Created M. Horak
Illustrative. Sample data.
- Who, what, when, where, and how, for every action
- Failed and repeated entries retained, never overwritten
- Every signature carries its signer and timestamp
ALCOA+, enforced by system control.
| Principle | System control |
|---|---|
| Attributable | Named accounts, role-based access, and electronic signatures |
| Legible | Readable records for the full retention period |
| Contemporaneous | Server timestamp at the moment of entry |
| Original | Source capture, with first versions preserved |
| Accurate | Field validation and laboratory import |
| Complete | Failed and repeated entries retained |
| Consistent | Enforced workflow sequence |
| Enduring | Configurable retention, patching without data loss |
| Available | Retrieval on demand, with remote reviewer access |
| Traceable | Every data point linked to source and change |
| Traceable is the ALCOA++ principle applied in GCP settings; it has no formal regulatory definition. | |
Built to GAMP 5, validation-ready.
What ZINOS supplies
Supplier documentation, configuration specifications, test evidence, and traceability from requirement to test.
What your hospital validates
Under GAMP 5, your institution validates the system for its own intended use, and no vendor holds a GAMP certification.
What that changes
Your quality team starts from documented controls and test evidence, rather than writing the validation from scratch.
Review the documents with your QA lead.
On a call, we agree the supplier documents your team needs, then share them under NDA and walk through them.