Guide
Bench execution record or electronic lab notebook: what changes at inspection
Published October 25, 2026
An inspector opens a study file and asks when step 14 was done. In the notebook, the entry carries a date and a time. What remains to be known is whether it is the time of the action or the time of the entry.
This page is for QA staff and lab heads who hesitate between writing a step up afterwards in an electronic lab notebook (ELN) and recording it at the moment it happens. It does not replace your validation, and it does not ask you to drop your ELN. It describes what each practice lets you demonstrate.
The time of the entry is not the time of the action
An ELN is written afterwards, from memory. It timestamps the entry: it tells you when someone wrote, not when someone pipetted.
At the hood you wear gloves, your hands are wet, a timer is running. You remember, you jot on a scrap of paper, you reconstruct later. The result is tidy and probably accurate. But the gap between "accurate" and "demonstrable" is what an inspector looks at.
US GLP requires data to be recorded directly and promptly, each entry dated on the day of entry and signed or initialed by the person entering it; for automated data collection systems, the person responsible for data input must be identified at the time of input (21 CFR 58.130(e)). ALCOA describes data that is attributable, legible, contemporaneously recorded, original and accurate (FDA data integrity guidance, December 2018, which addresses CGMP); ALCOA+ adds complete, consistent, enduring and available (MHRA GxP guidance, March 2018). An entry written in the evening for the day's steps raises the question of time.
What an ELN does well
Hypotheses, experimental plan, interpretation of a result, discussion between colleagues: all of this is written afterwards, and that is normal. This is what an ELN is for. Here, the time of the action is not the issue.
The limit appears when the entry has to serve as proof of execution. Depending on its configuration, an ELN can carry signatures and an audit trail. That does not change when the person wrote.
What changes when the step is recorded at the action
The approved protocol is displayed at the workstation, step by step. The operator signs the step at the moment they perform it, with the reagent lot and the equipment used. Nothing is re-entered in the evening. The data is attributable and contemporaneous, in the spirit of ALCOA+.
Three consequences at inspection.
The signature covers a step, not a page and not the study. It ties an authenticated person to an action. The detail is on the electronic signature and Part 11 page.
The lot and the equipment are attached to the step. Depending on how an ELN is set up, they are copied in as free text, and finding every step that used a doubtful lot then depends on how each person wrote it. Here, they are recorded with the signature. Can you list every step for a given lot? That is a question to put to any vendor, us included.
The workstation keeps recording when the network drops and resynchronizes on its own. Which clock counts offline belongs in your validation documents.
The limit: a signature shows that an authenticated person declares they performed the step. It does not show the action was done well. That is what the declared deviation and QA review are for.
The closer the evidence is to the action, the less it depends on memory.
What the inspector can verify alone
The audit trail is append-only, timestamped and SHA-256 hash-chained: tampering shows. At the end of the study, the Audit Pack gathers the approved protocol, the signatures, the deviations and the trail in a sealed deliverable. Your sponsor and your inspector can verify it without taking your word for it.
Two limits. A hash chain reveals alteration, it does not stop a wrong value from being entered. And sealing starts when the sample is received and stops when the result is handed over. What comes before and after is outside the scope.
What neither one settles
Computerized system validation remains each organization's responsibility. Biotraxion provides the technical traceability building blocks, not a label. Whether a system fits your studies is for you, your QA and your authorities to conclude.
Neither replaces staff training or account management. Part 11 asks for adequate training (§11.10(i)), signatures unique to one individual (§11.100) and controls on identification codes and passwords (§11.300).
Neither picks your framework. Depending on your sponsors and authorities, you work with Part 11, Annex 11 or OECD GLP Advisory Document no. 17, Application of GLP Principles to Computerised Systems (2016, revised 2022).
Six questions for any system
- Is the recorded time the time of the action or the time of the entry?
- Who signed each step, and how were they authenticated at that moment?
- Are the lot and the equipment linked to the step, or copied into free text?
- What happens to a correction: does the old value stay readable?
- What happens when the network drops, and which clock counts?
- Can a third party verify the file without taking your word for it?
For the last one, our answer is the Audit Pack.
See where your file loses the trail
We show a sample Audit Pack and go through where your current records lose the trail: contact@biotraxion.com, or request a pilot from the home page.