Pharmaceutical

Ensure traceability from packaging to dispensing

Serialization and traceability from package to patient

Pharmaceutical manufacturers operate in one of the world’s most highly regulated supply chains, where products must be accurately identified, serialized, and traceable. BarTender combines Labeling and Track & Trace to help organizations support DSCSA and EU FMD requirements, improve supply chain visibility, and maintain control from packaging through distribution.

Trusted by pharmaceutical producers worldwide

What is integrated labeling and tracking for pharmaceuticals?

In pharmaceutical operations, integrated labeling and tracking connects compliant label creation with the systems that serialize, verify, and track every package as it moves through the supply chain. The label is a regulated component of the product itself, carrying serialized identifiers, lot and batch numbers, expiration dates, and GS1 barcodes that support DSCSA and EU FMD traceability requirements. By bringing labeling and tracking together, BarTender helps manufacturers maintain audit-ready data while improving package verification, reconciliation, and traceability across the supply chain.

Serialization compliance built into every label

BarTender helps pharmaceutical manufacturers meet DSCSA, EU FMD, and other global serialization requirements, including support for GS1 DataMatrix barcodes that encode GTIN, serial number, lot number, and expiration date at the unit, case, and pallet level. With pharmaceutical serialization now mandated across much of the world, centralized template management helps ensure regulatory updates are applied instantly across every facility, with Intelligent Templates that automatically populate variable data from ERP, PLM, and serialization systems.

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Audit-ready records from labeling through distribution

Pharmaceutical manufacturers must meet strict electronic records and signature requirements under FDA 21 CFR Part 11. BarTender supports secure record creation and modification, electronic signatures attributable to individual users, role-based access controls, and tamper-evident audit trails. Version control captures who accessed a label, what changes were made, and where and when it was printed, while Track & Trace records every receiving, movement, and shipment event. Teams can quickly access complete documentation for audits and inspections.

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Scan-based receiving that protects serialization integrity

BarTender Track & Trace replaces manual receiving with scan-based verification against Advance Ship Notices. Operators scan barcodes or RFID tags, and the system validates each item against expected shipments in real time. Quantities are confirmed, discrepancies are flagged immediately, and serialized data flows automatically into your ERP. For manufacturers coordinating with CDMOs, contract packagers, and distribution partners, accurate receiving data helps maintain traceability records and reduce serialization errors, preventing quarantined product and downstream verification failures.

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Success Story

NovaCina realizes +30% cost savings by printing labels in-house

Learn how NovaCina modernized its pharmaceutical labeling by bringing label production in‑house with BarTender Intelligent Templates integrated with Microsoft Dynamics ERP. The solution streamlined regulatory compliance across 80 countries, automated label reconciliation, and reduced reliance on outsourced printing.

Manage pharmaceutical labeling and tracking at global scale

Simplify global labeling updates

BarTender Intelligent Templates help manufacturers instantly apply label updates across thousands of SKUs and multiple facilities. Regulatory changes, market requirements, and product updates can be managed centrally and deployed globally—eliminating manual template-by-template revisions and keeping outdated labels out of circulation.

Reduce IFU and multi-level packaging complexity

BarTender aggregates serialized data across pallets, cases, and units, increasing accuracy and simplifying template management. Tables let you group IFUs with shipping and packaging labeling by product, populating data from a single source and reducing the risk of mismatched documentation at the packaging line.

Enable compliant labeling across partner networks

BarTender helps pharmaceutical manufacturers extend approved labeling workflows to CDMOs, contract packagers, and logistics partners while maintaining centralized template governance. Browser-based access, audit trails, and controlled printing help support regulatory compliance across the extended supply chain.

Better together

Keep production moving—with full visibility, built in

When labeling and tracking are disconnected, errors multiply and visibility disappears. BarTender brings them together—so every label becomes the start of a complete, traceable record.

One source of truth
Label data flows directly into tracking—no duplicate entry or mismatched records
Instant traceability
Track items from creation through production, storage, and shipment
Faster audits and recalls
Access a complete history of every item, label, and movement
Simplified operations
One platform, one system, one partner for labeling and tracking

Modernize your pharmaceutical operations with BarTender

Simplify your labeling. Gain real-time visibility. Improve accuracy across every stage of production.

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Labeling and tracking for Pharmaceuticals FAQs

Yes. BarTender supports DSCSA serialization requirements, encoding GS1 DataMatrix barcodes with GTIN, serial number, lot number, and expiration date at the unit, case, and pallet level. Intelligent Templates integrate with ERP and serialization systems to populate variable data automatically at print time, helping maintain serialization consistency across your entire printer network.

Yes. BarTender supports EU FMD labeling requirements with 2D DataMatrix encoding and integration with serialization platforms for European market compliance. Centralized template management helps ensure label data aligns with regulatory submissions.

BarTender supports 21 CFR Part 11 requirements with secure electronic records, electronic signatures, role-based access controls, password-protected authentication, and tamper-evident audit trails. Detailed version history records who accessed a label, what changes were made, and where and when it was printed.

BarTender Labeling creates serialized, compliant pharmaceutical labels with GS1 barcodes, lot data, and product identifiers. Track & Trace scans, reconciles, tracks, and reports on every item across your supply chain. Together, they help pharmaceutical manufacturers maintain serialization integrity and product traceability from label creation through distribution.

Yes. BarTender integrates with SAP, Microsoft Dynamics, and other ERP, PLM, and serialization systems. Variable data can be pulled directly from validated source systems at print time, helping reduce manual data entry and improve labeling accuracy.

BarTender aggregates serialized data across pallet, case, and unit levels from a single file, increasing accuracy and reducing the number of templates to manage. The tables feature groups IFUs with shipping and packaging labeling, populating from a single data source.

Yes. BarTender enables CDMOs, contract packagers, and other external partners to access approved label templates through a browser-based interface, with no local software required. Centralized governance and audit trails help maintain labeling consistency and regulatory compliance across the extended supply chain, for both internal and external operators.

BarTender is available as on-premises software, cloud-based software, or a hybrid deployment. Pharmaceutical manufacturers often choose on-premises deployments for high-volume manufacturing with strict validation requirements, while BarTender Cloud supports multi-site operations and partner enablement. Hybrid deployments combine centralized control with flexible access across manufacturing, packaging, and distribution networks.