GUIDE · UPDATED 2026
Part 11 and the file that changes systems
Most Part 11 attention goes to the systems themselves: the chromatography data system, the LIMS, the ELN. The moment between them gets less attention — the file exported on one system and imported on another. That gap is where inspection findings about incomplete audit trails often start.
Written by Taha Bayar, a biologist working on laboratory data handover. Kionel sells one of the options below; the comparison is meant to be usable even if you choose another.
This is not legal or regulatory advice. Your quality unit decides how a tool is validated and used under your procedures.
What the regulations ask, in plain terms
- Audit trails (21 CFR 11.10(e), EU GMP Annex 11 §9): changes to electronic records are recorded with who and when, and the trail is retained with the record.
- Accuracy and integrity checks (11.10(a), Annex 11 §5 on data exchange): when data moves between systems, there should be checks that it arrived correctly and completely.
- Validation (11.10(a), Annex 11 §4): the tools involved do what they are supposed to, in your environment.
- Electronic signatures (11.50–11.300): a signature identifies the person, their intent and the time, and cannot be copied to another record.
Where a manual USB transfer falls short
A file copied to a stick and back leaves, at best, a line in a paper log. Nothing proves the bytes that arrived are the bytes that left, which work order they belonged to, or that nobody opened them in between. That is the gap: not the systems, but the handover.
What a signed transfer record covers — and what it does not
| Expectation | A signed dispatch and delivery record |
|---|---|
| Data arrived exactly as sent | Yes — the content hash is signed on both sides |
| Transfer tied to a work order | Yes — the reference is inside the signed record |
| Tamper evidence after the fact | Yes — any edit breaks the signature |
| Which person sent it | No — the signature identifies a device, not a person |
| Part 11 electronic signature | No — use your system's e-signature for approvals |
| Validated in your environment | Your validation, not the vendor's claim |
Where Kionel fits
Kionel produces the transfer evidence: a dispatch record signed by the sending device and a delivery receipt signed by the receiving device, both bound to the file's hash and the work order, both verifiable offline years later with a free tool. It does not replace your systems' audit trails or e-signatures, and it is not certified or pre-validated. It closes the gap between two systems that already have their own controls.
Try it on your own bench
The demo moves a sample file between two of your own devices, end to end, including both signed records. Nothing is uploaded.