Electronic Batch Review

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated December 2025 • electronic batch review, batch review by exception, release cycle time, eBR/eBMR evidence, deviations and holds, audit-ready batch packets • Regulated Manufacturing (USA)

Electronic batch review is how regulated manufacturers stop treating batch release like a scavenger hunt. The goal is not “to have a digital batch record.” The goal is to make review fast, consistent, and defensible—so QA can release product based on trustworthy evidence instead of chasing signatures, reconciling paper, and resolving contradictions across systems.

In many plants, QA review time is driven by the same root causes: missing evidence, unclear accountability, uncontrolled overrides, inconsistent exception handling, and weak linkage between what happened on the floor and what ended up in the batch packet. Electronic batch review fixes this by turning review into a structured process: completeness checks, exception highlighting, traceable approvals, and controlled dispositions tied to the actual event history.

“Batch review doesn’t need to be slow. It needs to be certain.”

1) What US buyers really mean by electronic batch review

When regulated manufacturers say “we need electronic batch review,” they usually mean:

• We need faster release. QA is spending too long reviewing and chasing evidence.
• We need fewer errors. Missing steps and missing signatures are causing rework and investigations.
• We need consistent decisions. Two reviewers shouldn’t produce two different outcomes for the same scenario.
• We need defensible evidence. Batch packets must stand alone in audits.
• We need better exception handling. Deviations and overrides must be structured and easy to review.

Electronic batch review is not just “viewing a PDF.” It is the integration of execution evidence, quality governance, and inventory status into one reviewable story.

2) Define success: batch review KPIs that matter

3) What electronic batch review must cover (scope map)

Electronic batch review only works when it covers the full evidence story. Typical scope includes:

• Execution evidence step completion, operator sign-offs, timestamps, equipment assignment
• Material control lot verification, materials consumption recording, reconciliation
• Critical checks in-process verification, pass/fail controls, sampling triggers
• Exceptions deviations, holds, rework, overrides, missing data
• Approvals review/approve steps, QA disposition, release decision (electronic signatures if applicable)
• Audit trails critical edits and reason-for-change (audit trails)
• Outputs exportable batch packet (PDF/CSV) and evidence attachments
• Traceability lot genealogy and exposure readiness (lot genealogy)

4) Batch review by exception (BRBE): why it changes everything

Batch review by exception (BRBE) is the single most valuable concept in electronic batch review. The idea is simple:

• Routine, compliant steps don’t require heavy QA attention.
• QA time should focus on exceptions: missing data, overrides, deviations, out-of-tolerance results, holds, rework, and unusual patterns.

BRBE works only when the system can reliably classify what counts as an exception. That requires:

• Hard-gated execution to prevent silent skips (hard gating).
• Clear data completeness rules (required fields and evidence attachments).
• Structured exception records (deviation forms, override rationale, approvals).
• Traceable links from exceptions to the batch step, lot, and equipment involved.

5) Evidence integrity: audit trails, signatures, and controlled edits

Electronic batch review rises or falls on evidence integrity. “Digital” is not automatically “trustworthy.” You need controls that make the record defendable:

• Attributable actions: unique users and role authority (role-based access).
• Audit trails: old/new values + reason-for-change on critical fields (audit trail).
• Signature meaning: review vs approve vs execute captured where needed (electronic signatures).
• Record locking: signed/approved records should not be silently editable.
• Exportability: the batch packet should be exportable and readable without “screenshots as evidence.”

6) Exceptions: deviations, holds, rework, and overrides

Electronic batch review is where exceptions must be visible and governed. Common exception types include:

• Deviations: departure from procedure or expected outcome (deviation management).
• Holds/quarantine: restricted lots must be enforced (hold/release).
• Rework/repack: controlled rework and preserved lineage (rework/repack traceability).
• Overrides: tolerance overrides, gated step bypasses, manual data entry exceptions.
• Missing evidence: skipped checks, missing attachments, incomplete training requirements.

Good batch review software makes these exceptions the first-class objects of review: each exception has a record, evidence, disposition, and approval trail. That’s what enables BRBE.

7) Traceability inside batch review: genealogy and exposure readiness

A strong batch review system should let QA pivot from the batch to its lot genealogy quickly:

• Upstream: which supplier lots were consumed, with COAs and test evidence.
• Downstream: which finished lots were produced and which shipments/customers were exposed.

This matters because release is not just “did we follow the procedure.” It’s also “can we prove what this batch is made of and where it will go if something is wrong.” Linkage to lot genealogy is what makes batch review useful under pressure.

8) The vendor demo script (copy/paste) + scorecard

Use this script to compare systems fairly. It forces end-to-end proof of BRBE and evidence integrity.

9) Selection pitfalls (why eBR projects disappoint)

• Digital paper. If you just replicate paper workflows, review is still slow and inconsistent.
• No hard gating. If steps can be skipped, the batch record becomes narrative-heavy and weak.
• Exceptions handled in email. BRBE fails if exceptions aren’t structured in the system.
• Weak audit trails. If edits aren’t governed, auditors will question record integrity.
• Export is unusable. If exports are cryptic, you’ll resort to screenshots in audits.
• No integration. Without WMS/QMS linkage, holds and genealogy can be inconsistent.

10) How this maps to V5 by SG Systems Global

V5 supports electronic batch review by connecting execution evidence, inventory status, and quality governance into one audit-ready story.

• Execution evidence + eBR: V5 MES supports controlled execution, evidence capture, and exception handling that feeds batch review.
• Quality governance: V5 QMS supports deviations/CAPA/approvals and governed dispositions tied to batches and lots.
• Inventory enforcement: V5 WMS supports enforceable hold/quarantine and shipment traceability.
• Integration layer: V5 Connect API supports structured exchange (API/CSV/XML) to ERPs and external systems.
• Platform overview: V5 solution overview.

11) Extended FAQ

Q1. What is electronic batch review?
It is the structured review of batch execution evidence using electronic records, focusing on completeness, exceptions, and governed decisions.

Q2. What is batch review by exception (BRBE)?
BRBE is a method where QA focuses review time on exceptions (deviations, overrides, missing data) rather than reading every routine step.

Q3. Why do electronic batch review projects fail?
Most failures come from implementing “digital paper,” lacking hard gating, and handling exceptions outside the system (email/spreadsheets).

Q4. Do we need electronic signatures for electronic batch review?
Not always, but if electronic approvals replace handwritten approvals, governed electronic signatures and audit trails become critical.

Q5. How does electronic batch review improve recall readiness?
Strong batch evidence and linkage to lot genealogy improves exposure reporting speed and reduces unknown links during investigations.

Related Reading
• Batch Records: Electronic Batch Record (EBR) | eBMR | BRBE
• Exceptions: Deviation Management | Hold/Release | Rework/Repack Traceability | Hard Gating
• Integrity + Proof: Audit Trail | Electronic Signatures | Data Integrity
• Traceability: Lot Genealogy | Recall Readiness
• V5 Products: V5 Solution Overview | V5 MES | V5 QMS | V5 WMS | V5 Connect API