Paperless Batch Records

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

Updated December 2025 • paperless batch records, eBR/eBMR, electronic batch review, audit trails, Part 11-style controls, batch release speed • Regulated Manufacturing (USA)

Paperless batch records are not “batch records on a screen.” They are a shift in how evidence is created: instead of documenting what you think happened after the fact, you capture what actually happened at the point of work—scans, scale weights, timestamps, device IDs, checks, and governed exceptions. When done right, paperless batch records reduce execution errors, accelerate QA release, and make audits boring. When done wrong, they create a new kind of chaos: digital paper that still requires manual checking, reconciliation, and screenshots as evidence.

Most companies go paperless for the obvious reasons: paper is slow, fragile, and inconsistent. But the real value of going paperless is not saving paper. It’s enforcing control at the highest-risk points (lot identity, weigh/dispense, critical checks, holds, deviations) and enabling review by exception so QA spends time on what matters instead of re-reading routine steps.

“Paperless isn’t the goal. Controlled evidence is the goal. Paperless is the side effect.”

1) What buyers mean by paperless batch records

When manufacturers ask for paperless batch records, they usually mean:

• Faster release because QA isn’t chasing missing signatures and illegible handwriting.
• Fewer errors because wrong-lot and wrong-weight events are prevented, not discovered later.
• Better audit readiness because evidence is consistent and exportable.
• More traceability because consumption and genealogy links are captured automatically.
• Scalability because record quality no longer depends on who is on shift.

2) KPIs paperless batch records should improve

3) Scope map: what “paperless” must capture

A real paperless batch record captures the execution story end-to-end:

• Master linkage batch tied to approved master version (MMR)
• Material identity lot-verified scanning and controlled substitutions
• Weigh/dispense evidence scale integration and tolerances (weigh/dispense)
• Process steps sequencing, required fields, operator sign-offs
• In-process checks pass/fail checks and sampling triggers
• Exceptions deviations, holds, rework, overrides
• Audit trails changes and reason-for-change (audit trails)
• Review & release exception-driven review queue (BRBE)
• Exports readable batch packets without screenshots
• Traceability consumption links to lot genealogy

4) Digital paper vs controlled execution

Paperless batch record solutions fall into two categories:

5) Evidence integrity: audit trails, signatures, record locking

Paperless evidence must be defensible. Requirements include:

• Unique identities: no shared logins; role-based access (RBAC).
• Audit trails: old/new values and reason-for-change for critical edits.
• Signature meaning (if used): execute/review/approve captured consistently (electronic signatures).
• Record locking: signed/released records should not be silently editable.
• Exportability: batch packets should be readable outside the system.

6) Devices: scanners, scales, printers, and why integration matters

Paperless batch records become trustworthy when evidence is captured automatically. The usual device stack:

• Barcode scanners for lot verification and movement capture.
• Scales for automated weigh/dispense evidence (no transcription).
• Label printers for controlled label issuance and reconciliation.
• Checkweighers/vision for in-process verification when relevant.

Device integration must be stable and auditable. Disconnected devices lead to bypass behavior (manual entry), which is how paperless systems quietly degrade.

7) Exceptions: deviations, holds, rework, overrides

Exception handling is where paperless systems either become powerful or become messy. Your system should treat exceptions as governed objects:

• Deviations: structured capture and investigation (deviation management).
• Holds/quarantine: enforceable status controls (hold/release).
• Overrides: approvals + rationale + audit trail evidence.
• Rework/repack: controlled workflows preserving lineage (rework/repack traceability).

8) Electronic batch review and BRBE

Paperless batch records deliver the biggest ROI when they enable electronic batch review and batch review by exception (BRBE):

• Routine steps are completeness-verified automatically.
• QA focuses on exceptions and their dispositions.
• Review screens highlight missing evidence, overrides, deviations, and holds.
• Release packets can be exported with full evidence.

This is what converts paperless records from “documentation” into “faster release.”

9) Validation readiness: what “prove it” looks like

Even in supplement environments that aren’t fully Part 11-heavy, buyers often expect Part 11-style behaviors for data integrity. Paperless batch records should support validation evidence through:

• clear configuration/version control,
• testable workflows (wrong lot, out-of-tolerance, override approvals),
• exportable evidence packets for audits,
• controlled access and audit trail review processes.

10) Copy/paste vendor demo script and scorecard

Use this script for every vendor. It exposes digital-paper systems quickly.

11) Selection pitfalls (why paperless projects fail)

• “Paperless” without enforcement. Digital forms don’t prevent errors.
• Manual entry allowed. Under pressure, it becomes the default and evidence degrades.
• Exceptions in email. BRBE becomes impossible and audits become painful.
• Weak exports. Screenshot-based evidence wastes time and reduces credibility.
• Integration gaps. If WMS/MES/QMS disagree on lots and holds, your record becomes contradictory.
• Overcomplication. Heavy workflows cause bypass behavior and drift.

12) How this maps to V5 by SG Systems Global

V5 supports paperless batch records by connecting controlled execution evidence to enforceable inventory status and quality governance.

• Execution evidence: V5 MES supports hard-gated steps, weigh/dispense, and electronic batch evidence.
• Governance: V5 QMS supports deviations/CAPA, approvals, and audit-ready exception handling.
• Containment: V5 WMS supports enforceable holds/quarantine and lot movement traceability.
• Integration: V5 Connect API supports structured exchange to ERPs and external systems.
• Platform view: V5 solution overview.

13) Extended FAQ

Q1. What are paperless batch records?
Paperless batch records are electronic records that capture batch execution evidence at the point of work, including devices/scans/checks, with governed exceptions and exportable audit packets.

Q2. Do paperless records require Part 11 electronic signatures?
Not always. But if electronic approvals replace handwritten approvals as compliance evidence, governed e-signatures and audit trails become important.

Q3. What is the biggest mistake when going paperless?
Digitizing forms without enforcing controls—manual entry and informal exceptions persist, so QA workload doesn’t drop.

Q4. How do paperless batch records speed release?
They enable review by exception: routine steps are completeness-verified automatically and QA focuses only on exceptions.

Q5. What should we demand in demos?
Proof of wrong-lot blocking, out-of-tolerance handling, governed exceptions, BRBE review screens, and readable export packets.

Related Reading
• Batch + Review: Electronic Batch Review | Review By Exception | BRBE
• Dispensing Evidence: Weigh and Dispense Software | Weighing Audit Trails | Weighing Tolerance Limits
• Exceptions + Integrity: Deviation Management Software | Audit Trail Software | Electronic Signatures Part 11
• V5 Products: V5 Solution Overview | V5 MES | V5 QMS | V5 WMS | V5 Connect API