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
Kionel is free and open source (AGPL-3.0): it moves files up to 64 MB between two of your devices, end to end, with signed records and reports. Nothing is uploaded.
Start free What Kionel does not protect
If the file has to stay on a USB stick, the same two signed records can be made around it: keep the USB stick, add the proof.