Global Batch Traceability – V5

Audit-Ready Manufacturing

Global Batch Traceability with V5 – Enterprise-Grade, Multi-Regime Compliance

Global batch traceability is the baseline expectation for regulated manufacturing—pharma, supplements, food, medical devices, cosmetics, and chemicals. It means you can prove, instantly, how every batch was made across plants and borders: every ingredient, every weigh, every sign-off, every shipment. V5 Traceability unifies MES, QMS, and WMS with tight ERP integration so compliance is executed live—not reconstructed later. No spreadsheets. No guesswork. Audit-ready by default.

“With V5, global batch traceability isn’t a paper chase. It’s live, enforced, and visible at every plant worldwide.”

— Director of Quality, Global CMO

Standards & Frameworks (Built In, Not Bolted On)

V5 operationalizes traceability against the frameworks that actually show up in audits and buyer questionnaires: 21 CFR Parts 210/211 (drug GMP), Part 11 (e-records & e-signatures), Part 111 (dietary supplements), ISO 13485 (devices), ISO 22000/HACCP (food), plus GFSI schemes like BRCGS and SQF, and the FDA’s Food Traceability Rule (FSMA 204). The point isn’t to admire the standards—it’s to enforce them while you work.

Pharma/biotech: lot genealogy, signature enforcement, deviation/CAPA, validated execution.
Food & beverage: KDE/CTE capture for FSMA 204, allergen zoning, FEFO, recall drills.
Devices: eDHR integrity, unit/lot device trace, ISO 13485 alignment.

Regulatory calendars move. Your execution shouldn’t. If timelines shift (e.g., proposed FSMA 204 date extensions), V5 still captures the same KDEs at the same CTEs—so you stay ready without rewriting your process.

Real-Time Enforcement: Records That Build Themselves

Global traceability fails where people are allowed to “fix it later.” V5 blocks that. Every critical step is enforced and attributed in the moment—so your BMR/MMR/eBR/eDHR assembles itself as you run the batch:

Lot & expiry control: scan-first validation at receiving, staging, weigh, and issue; wrong/expired lots simply don’t pass.
Sequence & line clearance: digital checks before starts and changeovers; no clearance, no start.
Calibration at the point of use: devices are verified before they’re allowed to weigh, fill, test, or print.
Deviations → CAPA: exceptions open QMS workflows immediately with cause/effect context from the line.
Yield, scrap, rework: captured in-line for mass balance and continuous improvement, not guessed after the fact.

The output is not a binder—it’s an electronic record with hyperlinks through genealogy, jobs, lots, and shipments. Auditors go straight to the evidence instead of waiting for reconciliations.

ERP Integration: Close the Loop From PO to Pallet

Planning sits in ERP. Enforcement sits in V5. V5 Connect and the V5 API sync orders, BOMs, lots, consumption, CoAs, and inventory moves in real time—so finance, supply chain, and QA see the same truth without rekeying. Whether you run NetSuite, Microsoft D365, Sage X3, QuickBooks, Jiwa, or a homegrown system, data flows both ways with role-based controls.

Inbound: masters, orders, and material receipts flow from ERP to V5 terminals.
Outbound: consumption, yields, holds/releases, CoA PDFs, and shipment confirmations flow back.
Plant connectivity: optional PLC links for scales, fillers, checkweighers, and printers unify device events with the batch narrative.

Weighing & Scanning: Precision You Can Defend

Most traceability collapses at the scale. V5’s batch weighing and formula control make that impossible to ignore. Operators scan the right material, weigh to enforced tolerances on calibrated devices, and get forced prompts for clean-downs and label checks where relevant. Every event carries who/what/when/where—plus a tolerances trail you can show in an instant.

Barcode verification blocks look-alike materials or expired lots.
Sub-gram targets and “green-zone” aids increase speed without sacrificing precision.
Automatic label printing ties lots/expiry/operators to units, cases, pallets.
Every weigh is time-stamped with device ID and tolerance result.

Result: fewer deviations, tight mass balance, and records that stand up to regulators and brand auditors.

Electronic Records: eBR, eDHR & Batch Review—Without the All-Nighter

V5 turns batch records into living systems of record. eBR/eDHRs aren’t compiled after the fact; they’re created as you run—complete with signatures, exceptions, equipment logs, and links to raw data. Batch review shifts from “document archaeology” to point-and-click QA:

Review in minutes: missing data and late signatures are clearly flagged before release.
Hyperlinked genealogy: jump from finished lot → ingredients → supplier → receiving QA in one flow.
Export when needed: PDFs for auditors; structured data for BI and customer portals.

Recall Response & Risk Mitigation: Minutes, Not Weeks

When it matters most, you need forward/backward trace in a single query. V5 maps finished goods to inbound lots, lines, operators, devices, labels, and customers. You can lock inventory, block picks, and export customer/pallet lists in minutes—razor-targeted and defensible. For food, KDE/CTE records align to FSMA 204’s structure; for GFSI schemes like BRCGS/SQF, you demonstrate four-hour trace performance without a scramble.

Industry Use Cases (One Platform, Different Regimes)

Pharmaceutical & biotech: Part 11 controls, dual sign-off where required, controlled changes, deviation/CAPA, stability links, and audit-ready eBRs.
Medical devices: eDHR integrity, component/serial trace, device test capture, ISO 13485 alignment.
Dietary supplements: 21 CFR 111 micro-ingredient control, allergen enforcement, clean-down prompts, and robust supplier/CoA links.
Food & beverage: ISO 22000/HACCP execution, allergen segregation, FEFO, packaging/label control, FSMA 204 KDE/CTE capture.
Cosmetics & chemicals: formula and batch enforcement, hazardous-material controls, global site consistency with local overrides.

KPIs & Visibility: Govern by Data, Not Anecdote

Traceability is not only about passing an audit; it’s about running a tighter operation. V5 surfaces the metrics that actually move:

Right-first-time: % batches released without rework/holds.
Mass balance: input→output reconciliation, waste by step (mix/proof/bake/fill/pack), and variance flags.
SPC & conformance: scheduled sampling, in-control rates, trend deviations by line/sku/equipment.
Release lead time: time from last operation to QA release, with bottleneck cues.
Recall readiness: search time to complete forward/backward trace pack.

Need enterprise dashboards? Pipe validated V5 data to your BI stack through the API without CSV gymnastics.

Frequently Asked Questions

What exactly is “global batch traceability”?
A unified, enforced record of how each batch was made—ingredients, steps, people, devices, labels, and shipments—searchable across every plant and region you operate.

How does V5 handle different regulations without extra busywork?
By embedding controls in execution: signatures, line clearance, calibration checks, allergen zoning, KDE/CTE capture, and deviation→CAPA flows. You follow the process; the system generates compliant evidence.

Can V5 support multiple sites and partners?
Yes. Govern centrally with plant-level overrides, role-based permissions, and ERP/API feeds. Contract sites can be brought into the same evidence model.

How fast is a recall drill?
Minutes. Search by lot/sku/date/supplier; lock inventory; export pallet/customer lists; print the evidence pack. No binder build, no manual reconciliation.

Will this reduce audit and recall risk?
Yes. When execution is enforced and attributed, records are credible by design—reducing findings, cycle times, and the blast radius of any issue.

Why V5: Compliance You Execute

Real-time control at every decision point—scan, weigh, sign-off, calibrate, label, ship.
Records build themselves (eBR/eDHR/MMR); nothing is stitched together later.
ERP integration for orders, consumption, yields, CoAs, and inventory—no double entry.
Multi-industry, multi-site scalability from day one; configuration first, custom code last.
Designed for audits under pressure—hyperlinked genealogy and evidence-rich reports.

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