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.
Engineered for Regulated & High-Velocity Industries
Whether driven by stringent statutory serialization mandates (EU FMD, DSCSA, UDI) or high-speed brand protection and recall containment, Mark2Trace delivers specialized hardware and software calibrated to your exact production reality.
Pharmaceuticals & Life Sciences
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.
Medical Devices & Diagnostics
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.
Food & Beverage / FMCG
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.
Explosives & Ammunition
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.
Chemicals & Agro-Chemicals
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.
Automotive & Industrial Components
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.
Modular Traceability Tiers (Levels 1–6)
Every production line is unique. Our solutions are structured in modular tiers—implement the exact levels required by your target markets, regulatory mandates (EU FMD, DSCSA, GS1), and supply-chain partner requirements.
Inline Production Integration
Camera visual inspection systems and tamper-evident mechanical hardware integration calibrated to rugged factory conveyors.
Serialization & Labeling
Manual Serialization Labeler (MSL) inline modules for roll generation alongside continuous automatic high-speed thermal transfer & laser ablation systems.
Digital Encoding
Strict GS1 standard compliance with high-contrast 2D DataMatrix cryptographic serialization encoding and print quality grading.
Hierarchical Aggregation
Parent-child hierarchy mapping connecting individual unit packs to secondary shipper cartons and multi-tier tertiary pallet loads.
Audit & Batch Reporting
Complete electronic batch records, tamper-proof audit trails, and automated batch closeout reports compliant with 21 CFR Part 11 and EU Annex 11.
Management & Insights
Complete site management software suite reporting real-time Overall Equipment Effectiveness (OEE), line telemetry, and multi-station KPI tracking.
Seamless Integrations
Connecting flawlessly with your existing ERP, WMS, and physical line controllers.
Direct Answers for Operations & Compliance Leads
Key insights into line retrofit compatibility, regulatory validation (EU FMD, DSCSA, 21 CFR Part 11), commissioning timelines, and enterprise ERP integration.
Line Retrofit check_circle Zero conveyor replacement — integrates with existing PLCs & coders Can Mark2Trace be retrofitted onto our existing packaging lines without replacing our current machines?
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Can Mark2Trace be retrofitted onto our existing packaging lines without replacing our current machines?
Yes. Mark2Trace 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.
Downtime & Commissioning check_circle 24–48 hour installation during planned maintenance windows How much production downtime is required during installation and commissioning?
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How much production downtime is required during installation and commissioning?
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.
Throughput & Velocity check_circle 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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Will 100% serialization and camera verification slow down our packaging line speed?
No. Mark2Trace 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.
Global Compliance check_circle 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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Which international serialization regulations and standards are covered out of the box?
Mark2Trace 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.
Modularity & Capex check_circle 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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Can we start with unit serialization and add multi-tier aggregation or OEE monitoring later?
Yes, this is one of our primary design advantages. Our modular 6-tier architecture allows you to deploy only what your immediate budget and market mandates require today. You can start with Tier 02 (Unit Serialization & Print Verification) and later scale to Tier 04 (Carton & Pallet Aggregation with SSCC generation) or Tier 06 (Plant-wide OEE & Line Telemetry) using the same software platform without replacing existing hardware or discarding prior investments.
ERP & Cloud Systems check_circle 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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How does the system connect with our corporate ERP, MES, and Level 4 serial number repositories?
Mark2Trace 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.
Data Integrity check_circle FDA 21 CFR Part 11 & EU GMP Annex 11 validated immutable audit trail Is Mark2Trace compliant with FDA 21 CFR Part 11 and EU GMP Annex 11 data integrity standards?
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Is Mark2Trace compliant with FDA 21 CFR Part 11 and EU GMP Annex 11 data integrity standards?
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.
ROI & Open Hardware check_circle 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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How does total cost of ownership (TCO) compare to proprietary OEM packaging solutions?
Legacy packaging OEMs typically lock manufacturers into proprietary hardware with expensive annual maintenance contracts and costly spare parts. Mark2Trace 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.