MARK/TRACE
ENTERPRISE TRACEABILITY SUITE • ISO 9001 & GS1 READY

End-to-End Track & Trace: From Physical Line to Site Management

Complete serialization, GS1 compliance, and real-time OEE reporting for modern pharmaceutical, packaging, and high-velocity manufacturing.

99.98% Verification Accuracy
Real-Time Line Synchronization
EPCIS 2.0 / 1.2 GS1 Protocol Ready
VERTICAL APPLICABILITY

Engineered for Regulated & High-Velocity Industries

Whether driven by statutory serialization mandates (EU FMD, DSCSA, UDI) or high-speed brand protection and recall containment, Mark & Trace delivers specialized hardware and software calibrated to your exact production reality.

medication
Mandatory Global Mandates

Pharmaceuticals & Life Sciences

EU FMD US DSCSA 21 CFR Part 11 Annex 11

Unit-level 2D DataMatrix serialization for vials, ampoules, syringes, and cartons. Real-time optical ISO 15415 Grade A grading, tamper-evident verification, and parent-child pallet aggregation with automated eBR dossiers.

Applicable Packaging Blisters, Vials, Bottles, Pre-filled Syringes, Shipper Cases
Up to 600 units/min • Zero unscannable units
medical_services
FDA UDI & EU MDR

Medical Devices & Diagnostics

FDA UDI EU MDR 2017/745 ISO 13485

High-contrast Direct Part Marking (DPM) and sterile barrier pouch labeling. Seamless tracking of Device Identifiers (DI) and Production Identifiers (PI) for implants, surgical kits, and diagnostic instruments.

Applicable Packaging Sterile Pouches, Tyvek Packs, Clamshells, Direct Metal DPM
ECC 200 laser ablation • High optical durability
nutrition
Food Safety & Recalls

Food & Beverage / FMCG

FSMA Rule 204 GS1 Digital Link ISO 22000

High-velocity serialization for bottles, cans, and cartons with rapid batch-to-farm recall isolation. High-speed vision inspection checks cap tightness, fill levels, and expiry date printing at maximum conveyor speed.

Applicable Packaging PET Bottles, Aluminum Cans, Tetrapaks, Shrink Trays
Up to 800+ units/min • Washdown IP67 ready
local_fire_department
EU 2008/43/EC • MIL-STD

Explosives & Ammunition

EU 2008/43/EC MIL-STD-130 STANAG 4427 ATF 27 CFR

Full lifecycle serialization and chain-of-custody tracking for civil explosives, defense energetics, ammunition rounds, and detonators. Headstamp laser marking, round-to-box-to-can aggregation, and tamper-proof electronic ledgers meeting strict defense and civil mandates.

Applicable Packaging Ammo Cans, Round Boxes, Cartridges, Detonators, UN Crates
Round-to-pallet aggregation • ATEX / Ex-rated hardware
science
Hazard Labeling & Security

Chemicals & Agro-Chemicals

GHS Compliance EPA Standards Anti-Counterfeiting

Inline labeling and Manual Serialization Labeler (MSL) roll stations for canisters, chemical drums, and IBC containers. Durable, chemical-resistant label roll generation preventing grey-market pesticide diversion.

Applicable Packaging Plastic Jerry Cans, Steel Drums, IBC Totes, Bag-in-Box
Harsh-environment labels • Pallet SSCC sync
precision_manufacturing
Part Genealogy & Warranty

Automotive & Industrial Components

ISO/TS 16949 VDA Standards AIAG Standards

Complete component genealogy tracking from raw sub-assemblies to final vehicle integration. Direct Part Marking (DPM) on cast metal, laser marking on PCBs, and Tier-1 to OEM supply chain validation.

Applicable Packaging Machined Parts, PCB Boards, Sub-assembly Trays, Crates
Sub-second cycle time • 100% Component genealogy
CUSTOM.CMO Operating in a specialized niche or contract manufacturing (CMO) environment? Our modular tiers adapt to custom line geometry and non-standard packaging substrates.
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MODULAR ARCHITECTURE • TIERS 01–04

End-to-End Packaging Aggregation Tiers

Structured hierarchical serialization engineered to meet global compliance mandates (EU FMD, US DSCSA, GS1 EPCIS) and supply-chain track-and-trace requirements from primary item to master shipping pallet.

01 [TIER_1_UNIT]
Pack Level • L1

Unit Serialization

High-speed direct 2D DataMatrix marking on cartons, vials, blisters, and bottles with real-time optical grade verification and millisecond reject diversion.

GS1 Syntax & Grade A (01)05412345678908(21)MNT-884920
Speed: Up to 800/min Reject: <15ms
02 [TIER_2_BUNDLE]
Multipack • L2

Bundle Aggregation

Multi-camera array reading bundled multipacks prior to shrink wrapping, establishing immutable parent-child relationships between unit codes and bundle labels.

Hierarchy Mapping 10x - 24x Units → 1 Bundle
Array: Multi-Camera Sync: Real-Time
03 [TIER_3_CARTON]
Shipper Case • L3

Carton Packaging

Case packer integration verifying complete child bundle or unit inclusion, automatically printing and applying GS1-128 shipping labels with aggregated packing manifests.

Case Label Verification GS1-128 / SSCC Case Barcode
Print & Apply: Auto Check: 100% Optical
04 [TIER_4_PALLET]
Master Pallet • L4

Pallet Aggregation

Robotic or manual pallet station scanning layer-by-layer, issuing GS1 SSCC-18 master pallet identifiers and synchronizing shipping events directly to warehouse WMS/ERP.

SSCC-18 Logistics Code (00)305412345678901234
Protocol: EPCIS 2.0 WMS: Bidirectional
SITE.L3 Need plant-wide OEE telemetry or 21 CFR Part 11 electronic batch records? Mark & Trace provides unified site controllers coordinating all packaging tiers.
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ENTERPRISE INTEROPERABILITY

Seamless Line & Enterprise Integrations

Engineered for open connectivity with your existing ERP, MES, shop-floor PLCs, and cloud serialization repositories.

ERP
Enterprise ERP Systems RFC, REST & OData sync
SAP/Oracle
MES
Manufacturing Execution SCADA & shop floor dispatch
Werum/Opcenter
PLC
Machine Controllers EtherNet/IP, OPC UA & Modbus
Siemens/AB
WMS
Warehouse Management Pallet, AS/RS & Bin routing
SSCC-18
EPCIS
GS1 EPCIS 2.0 / 1.2 Telemetry TraceLink, Arvato, SAP ATTP & compliance hub data sync
GS1 CERTIFIED
ENGINEERING & DEPLOYMENT FAQ

Direct Answers for Operations & Compliance Leads

Technical insights into line retrofit compatibility, regulatory validation (EU FMD, DSCSA, 21 CFR Part 11), commissioning timelines, and enterprise ERP integration.

Q01 Line Retrofit Zero conveyor replacement — integrates with existing PLCs & coders

Can Mark & Trace be retrofitted onto our existing packaging lines without replacing our current machines?

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Yes. Mark & Trace is engineered specifically as an open-architecture retrofit. Our modules mount directly onto your existing conveyors, continuous cartoners, blister machines, and case packers. Vision inspection cameras, thermal/laser coders, and high-speed pneumatic reject mechanisms communicate directly with your existing line PLCs (Siemens, Rockwell Allen-Bradley, Omron, Schneider) via industrial protocols (OPC UA, EtherNet/IP, Modbus TCP) without requiring costly line overhauls or vendor lock-in.

Q02 Downtime & Commissioning 24–48 hour installation during planned maintenance windows

How much production downtime is required during installation and commissioning?

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Zero unbudgeted downtime. All software configurations, recipe templates, and communication drivers are fully validated in our staging environment prior to on-site arrival. Physical bracket mounting, sensor wiring, and I/O loop testing are typically executed during a standard weekend maintenance window or planned batch changeover (usually 24 to 48 hours), allowing your line to resume scheduled production on Monday morning without disruption.

Q03 Throughput & Velocity Full 100% optical grading at line speeds up to 800 packs/min

Will 100% serialization and camera verification slow down our packaging line speed?

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No. Mark & Trace real-time vision algorithms process ISO/IEC 15415 optical grading and GS1 DataMatrix syntax validation in under 8 milliseconds. Operating at line velocities of up to 800 packs per minute, our systems trigger millisecond-precision pneumatic rejectors or air-blast nozzles with downstream confirmation sensors, ensuring non-compliant units are ejected instantly without slowing down conveyor throughput.

Q04 Global Compliance Native compliance for EU FMD, US DSCSA, Chestny ZNAK, and GS1

Which international serialization regulations and standards are covered out of the box?

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Mark & Trace comes pre-configured for all primary global pharmaceutical and high-velocity mandates: EU FMD (Directive 2011/62/EU), US DSCSA (interoperable electronic tracing), Russian Chestny ZNAK (crypto-code serialization & aggregation), Turkey ITS, and international GS1 General Specifications. All standard Application Identifiers (GTIN 01, Serial Number 21, Expiration Date 17, Lot/Batch 10) are validated in real time.

Q05 Modularity & Capex Deploy unit serialization now, add carton/pallet aggregation later

Can we start with unit serialization and add multi-tier aggregation or OEE monitoring later?

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Yes, this is one of our primary design advantages. Our modular architecture allows you to deploy only what your immediate budget and market mandates require today. You can start with Unit Serialization & Print Verification and later scale to Carton & Pallet Aggregation with SSCC generation or Plant-wide OEE & Line Telemetry using the same software platform without replacing existing hardware or discarding prior investments.

Q06 ERP & Cloud Systems Turnkey EPCIS 2.0 / 1.2 data exchange with SAP, Oracle, and TraceLink

How does the system connect with our corporate ERP, MES, and Level 4 serial number repositories?

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Mark & Trace acts as a turnkey Level 3 Site Management system. It pulls allocated serial numbers and production orders directly from corporate ERP/MES layers (SAP S/4HANA, SAP ATTP, Microsoft Dynamics 365, Siemens Opcenter) and cloud repositories (TraceLink, Arvato, rfXcel). Upon batch completion, validated commissioning, aggregation, and shipping events are exported via secure GS1 EPCIS 1.2 and 2.0 (XML/JSON) and REST APIs.

Q07 Data Integrity FDA 21 CFR Part 11 & EU GMP Annex 11 validated immutable audit trail

Is Mark & Trace compliant with FDA 21 CFR Part 11 and EU GMP Annex 11 data integrity standards?

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Yes. The system enforces strict role-based access control (RBAC), dual-operator authorizations for critical batch overrides, and cryptographic time-stamped audit trails logging every recipe change, failed print, and operator action. At batch closeout, an immutable, tamper-evident Electronic Batch Record (eBR) report is generated in validated PDF and XML formats ready for regulatory audits.

Q08 ROI & Open Hardware Up to 40% lower Capex with off-the-shelf industrial hardware & 24/7 SLA

How does total cost of ownership (TCO) compare to proprietary OEM packaging solutions?

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Legacy packaging OEMs typically lock manufacturers into proprietary hardware with expensive annual maintenance contracts and costly spare parts. Mark & Trace is built on standard, off-the-shelf industrial components (Cognex/Keyence optical sensors, Zebra/Sato industrial print engines, standard PLC I/O). This lowers initial capital expenditure by up to 40%, eliminates vendor lock-in, and cuts long-term support and spare-part costs substantially.

Have a custom line configuration or complex packaging setup?

Our validation engineers review line layout schematics, conveyor speeds, and camera focal requirements with no commitment.

Request Line Feasibility Review