Electronic batch records with review by exception
Master batch record configuration, guided execution on the floor, in-line exception capture, review by exception, disposition, and full batch genealogy.
Electronic batch records with review by exception
Master batch record configuration, guided execution on the floor, in-line exception capture, review by exception, disposition, and full batch genealogy.
THE PROBLEM
A paper batch record is hundreds of pages, and review means reading every one of them looking for the three that matter. It takes days, it happens at the end, and the people doing it are the most expensive in QA.
Electronic batch record systems exist, and most of them are a project measured in years. The master batch record has to be built, validated, and revalidated on every change, and changes are constant, so labs either accept a growing backlog of unvalidated process improvements or freeze the process to avoid triggering another revalidation cycle.
Labbit's electronic batch records are configured visually in BPMN, so a master batch record is a versioned configuration rather than a development deliverable. Execution is guided step by step with enforced order and e-signatures, exceptions are captured in-line, and review by exception filters the reviewer to flagged steps only. Review goes from days to hours. Manufacturers like Orca Bio and Ancera run batch records on Labbit.
PRE-CONFIGURED WORKFLOWS
Built visually in BPMN, adapted to your lab, and changed without a vendor release.
Instruments and platforms
What does review by exception mean in Labbit?
The reviewer queue shows only flagged steps, exceptions, and deviations rather than the full record. Steps that executed within limits do not require review.
How long does it take to build a master batch record?
Master batch records are configured visually in BPMN with versioning. Changes are configuration, not development, so revision cycles are days rather than months.
Does Labbit support electronic logbooks and line clearance?
Yes. Line clearance checks and equipment use logs are electronic and tied to batch steps, replacing paper logbooks.
Can Labbit produce full batch genealogy for investigations and recalls?
Yes. Forward and backward genealogy across materials, intermediates, and lots is stored in the graph and queried instantly.
SEE IT ON YOUR ASSAYS
Bring an assay your team runs today. We’ll show you how it’s configured, executed, and reviewed.