Audit Trails & Traceability
An attributable history of every record, connected to the workflow step, user, and signature behind
each change, captured automatically at commit and ready when an auditor asks.
An attributable history of every record, connected to the workflow step, user, and signature behind
each change, captured automatically at commit and ready when an auditor asks.
THE PROBLEM
In many labs, a retest overwrites the original result, investigations start without context, and nobody can see a test's full lifecycle in one place. The audit trail exists, but it's a log to be searched, not a history that explains itself.
When an auditor asks for the complete story of a sample, the team pieces it together from the LIMS, spreadsheets, and paper. The quality of the answer depends on how the system was set up years ago and on who still remembers why.
CAPABILITIES
Every commit creates a new revision with a system-generated timestamp and the user who committed it. Nothing depends on someone deciding what to log or remembering to log it later.
Labbit is designed so a change never overwrites what came before. The complete prior revision stays intact and linked to the new one, so reviewers can see the record exactly as it stood at any point in time.
The same connected record underpins chain of custody and chain of identity, with genealogy visible from receipt through release. Dedicated Chain of Custody and Chain of Identity modules build on it for cell and gene therapy.
Entity history shows the revision trail for core records such as samples and containers, and a field-level diff report compares revisions for audit and inspection. History is also available through the API for custom reporting.
HOW IT WORKS
01
Each committed step, result, and signature is recorded as a new revision, attributed to the user who committed it.
02
Every revision is linked to the sample, lot, instrument, user, and workflow step involved, so history stays in context rather than in a flat log.
03
Reviewers and auditors open a record's history, compare revisions field by field, or pull history through the API for inspection reports.
IN PRACTICE
GMP BIOMANUFACTURING
Vein-to-vein COI and batch execution
ANALYTICAL QC
EBR, release and CoA generation
ANALYTICAL QC
Scheduling, trending and alerting
GMP BIOMANUFACTURING
Check-weigh dispensing with genealogy
What does Labbit's audit trail capture?
For every committed change: who committed it, when, the complete state of the record before and after, and the context, including the workbook, the workflow task, and any e-signatures.
Can audit trail entries be edited or deleted?
No. Labbit is designed to be append-only. Corrections are made by revising or invalidating a record, which creates a new revision and leaves the original in place with its full history.
What happens to the original result when a test is repeated?
The repeated test is recorded as new work, and the original result remains on the record as its own revision. Nothing about the first result is overwritten, so reviewers see both with their full context.
How does Labbit support chain of custody and chain of identity?
Custody transfers and identity checks are recorded in the same connected history as every other action. For cell and gene therapy, the Chain of Custody and Chain of Identity modules add dedicated workflows on top of that record.
How quickly can we answer an auditor's request for a sample's full history?
Because Labbit records relationships and revisions as work is committed, a sample's history, including the workflow steps, users, and signatures involved, is available from its record without custom scripting or pulling records from other systems.
READY WHEN THE AUDITOR ASKS
Pick a sample scenario from your last audit. We'll show you what that history looks like in
Labbit.