What is review by exception?
Review by exception (RBE) is the practice of reviewing the batch record by exception, focusing on the out-of-specification values, the deviations, and the unusual patterns.
Electronic Batch Release
Electronic batch release and review by exception services for pharmaceutical manufacturers. The engagement covers the EBR review workflow, the deviation management, the QA approval, the review by exception logic, and the integration with the QMS.
EBR review workflow
The EBR review workflow covers the QA review of the batch record, the production review, the engineering review, and the QA approval.
Review by exception
Review by exception (RBE) is the practice of reviewing the batch record by exception, focusing on the out-of-specification values, the deviations, the exceptions, and the unusual patterns.
Deviation management
Deviations identified during the EBR review are managed in the QMS: the deviation record, the investigation, the CAPA, and the closure.
How to use this page
Use this Electronic Batch Release page as a planning checkpoint before vendor selection, architecture review, validation scoping or implementation sequencing. The strongest next step is to compare the guidance with your current SOPs, system inventory, batch records, data flows and QA review routines so the discussion starts from evidence instead of assumptions.
Evidence to prepare
For Electronic Batch Release, prepare the records, owners, risks and decision criteria linked to ebr review workflow, review by exception, deviation management. Useful evidence includes current process maps, interface lists, audit trail expectations, exception workflows, data retention rules and the business reason for changing the current operating model.
Frequently asked questions
How is RBE validated?
The RBE logic is validated as part of the MES validation.