Batch Control Records

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

Updated December 2025 • batch control records, controlled batch evidence, eBMR/eBPR, weigh & dispense enforcement, lot genealogy, review by exception, audit trails • Regulated Manufacturing (USA)

Batch control records are the evidence chain that proves a batch was executed under control—using the right materials, the right steps, the right checks, and the right approvals. They are not “the paperwork for the batch.” They are the operational proof that the batch was made correctly and can be released without guesswork. In regulated manufacturing, the batch record is often the single most important artifact because it ties together execution evidence, quality decisions, and traceability.

Most organizations think they have batch control records because they have batch documents. The difference is control. A controlled batch record prevents the classic failure modes: wrong-lot usage, wrong weights, skipped steps, missing checks, informal rework, and hold statuses that didn’t block anything. When batch control records are generated through hard-gated execution with scanners and scales, they become faster to review, easier to audit, and far more defensible than paper packets assembled after production.

“If the record is assembled after the batch is done, you’re reconstructing. Batch control records prevent reconstruction.”

1) What buyers mean by batch control records

When regulated manufacturers search for batch control records, they usually mean: “we need batch packets that are consistently correct and fast to release.” Common drivers:

• QA release is slow because evidence is missing and requires manual follow-up.
• Errors are happening (wrong lot, wrong weight, missed checks) and the record doesn’t prevent them.
• Audits are painful because retrieving defensible packets is slow.
• Traceability is weak because consumption is assumed rather than captured.
• Exceptions are off-system (email or notes), so the record is incomplete.

2) KPIs batch control should improve

3) Scope map: what must be captured in a batch record

A batch control record should cover the full execution story:

• Batch identity batch number, product, site/line, timestamps
• Master binding which approved master was used (MMR)
• Material identity lots used, substitutions, quarantine status checks
• Weigh/dispense evidence target vs actual weights, tolerances, scale IDs
• Step evidence required checks, signatures, timestamps
• In-process checks pass/fail evidence and sampling triggers
• Packaging controls line clearance and label reconciliation where applicable
• Exceptions deviations, holds, rework, overrides
• Disposition release decisions and approvals
• Exports readable packets without screenshots

4) Master linkage: MMR → batch record binding

Batch control starts with master control. A strong system ensures:

• Only approved master versions are executable.
• Each batch is bound to the master version used.
• Effective dates prevent drift.
• Changes are governed through approvals and change control (change control).

5) Execution control: steps, evidence, and hard gating

Controlled batch records are produced by controlled execution. Requirements include:

• Required fields: steps cannot be completed without required evidence.
• Step sequencing: critical steps cannot be skipped.
• Attributable actions: unique users and role-based access (RBAC).
• Hard gating: wrong-lot and failed checks are blocked or exception-controlled (hard gating).
• Device evidence capture: where possible, evidence comes from devices (scales/scanners) rather than manual entry.

6) Weigh & dispense control and tolerance enforcement

Dispensing is where most preventable batch record problems originate. A batch control system should enforce:

• Lot verification: scan the lot at point of use.
• Scale integration: capture weights directly from the scale.
• Tolerance enforcement: out-of-tolerance forces disposition (Weighing Tolerance Limits).
• Override governance: approvals + reason-for-change + audit trail evidence.

7) Exceptions: deviations, holds, rework, overrides

Batch control records must include the real story—especially when things go wrong:

• Deviations: structured records linked to step/lot/equipment (Deviation Management Software).
• Holds: enforceable hold/quarantine decisions (Quarantine & Release Software).
• Rework: controlled rework that preserves lineage.
• Overrides: governed approvals and rationale.
• CAPA linkage: recurrence triggers corrective action (CAPA Software).

8) Lot genealogy and exposure reporting

Batch control records should support rapid traceability:

• Upstream: which supplier/raw lots were used (Raw Material Traceability).
• Downstream: which finished lots and shipments were exposed.
• Evidence packets: batch, holds, deviations, and release decisions exportable.

If genealogy depends on manual reconstruction, your batch record is missing a key control: actual consumption capture.

9) Electronic batch review and BRBE

The fastest safe review model is exception-based review (Review By Exception). Batch control records should support:

• routine completeness checks automatically verified,
• exceptions highlighted and linked to evidence,
• release decisions made quickly and defensibly.

This aligns with Electronic Batch Review and Batch Release Software.

10) Data integrity: audit trails, signatures, record locking

Batch control records must be defensible. Requirements include:

• Audit trails: old/new values, who/when/why (audit trails).
• Electronic sign-offs: where approvals replace handwritten signatures (Electronic Signatures Part 11).
• Record locking: released records shouldn’t be silently editable; changes require controlled re-approval.
• Readable exports: batch packets stand alone without screenshots.

11) Copy/paste vendor demo script and scorecard

Use this script to compare vendors fairly.

12) Selection pitfalls (why records stay slow)

• Digital paper. Electronic forms without enforcement won’t reduce errors or QA time.
• Manual weights allowed. Evidence integrity collapses under rush conditions.
• Exceptions off-system. Email-based deviations destroy auditability and BRBE.
• Holds don’t block. Containment is fake and exposure grows.
• Weak exports. Screenshot evidence wastes time and reduces credibility.
• Master drift. Executing outdated masters documents process drift, not control.

13) How this maps to V5 by SG Systems Global

V5 supports batch control records by linking controlled execution evidence, enforceable status controls, and governed quality workflows.

• Execution evidence: V5 MES supports controlled batch execution and weigh/dispense evidence capture.
• Governance: V5 QMS supports deviations/CAPA, approvals, and audit-ready evidence packets.
• Containment: V5 WMS supports enforceable holds/quarantine and lot traceability.
• Integration: V5 Connect API supports structured exchange with ERPs and external systems.
• Platform overview: V5 solution overview.

14) Extended FAQ

Q1. What are batch control records?
They are the controlled evidence chain proving a batch was executed correctly, with lot identity, step evidence, exceptions, approvals, and traceability links.

Q2. Are batch control records the same as an eBMR?
eBMR is a common electronic form of a batch control record. The key is control and evidence integrity, not the file format.

Q3. What is the biggest improvement opportunity?
Hard-gated weigh/dispense with lot verification and tolerance enforcement, plus exception-driven review to speed release.

Q4. What should be included in an audit-ready packet?
Master linkage, lots used, dispensing evidence, step evidence, exceptions and dispositions, approvals/sign-offs, and audit trail excerpts for critical changes.

Q5. What should we demand in demos?
Proof of wrong-lot blocking, out-of-tolerance handling, deviation/hold workflows, BRBE review screens, and clean export packets.

Related Reading
• Batch Evidence: EBMR for Supplements | Paperless Batch Records | Electronic Batch Review
• Execution Controls: Weigh and Dispense Software | Review By Exception | Batch Release Software
• Integrity: Audit Trail | Electronic Signatures Part 11 | Data Integrity
• V5 Products: V5 Solution Overview | V5 MES | V5 QMS | V5 WMS | V5 Connect API