製薬

    Modernizing complex pharmaceutical labeling to bring drugs/medicines to market faster and more sustainably 

    60%

    AstraZeneca sees 60% reduction in artwork lead time

    98%

    GSK reduces label print time by 98%

    We have seen SAP label print times reduce by 98%.
    We've also achieved 75% reduction in label design time
    and 66% reduction in label design costs.

    Rob Worland, GSK’s Product Owner

    Powering pharma 4.0 with product identification

    The pharmaceutical industry has rapidly transformed with digitalization, AI, and evolving market demands. However, rising costs and fines, global regulatory pressures, and outdated systems hinder efficiency, traceability, and compliance.

     

    To stay competitive and improve patient outcomes, embracing product identification as part of Pharma 4.0 is essential to modernize cloud operations, enhance traceability, authenticity, and improve supplier connectivity to optimize supply chains.

    Streamline labeling & production

    Integrate artwork management and label production for medicines, clinical trials, secondary packaging, and distribution with speed and accuracy

    Enable global compliance

    Manage regulations such as FDA 21 CFR Part 11, DSCSA, and the EU’s Falsified Medicines Directive, reducing risks, errors, and fines

    Support global & regional labeling

    Ensure accurate label localization across languages and symbols, meeting evolving global requirements effortlessly

    Track & trace products

    Provide end-to-end traceability to support serialization and Digital Product Passport (DPP) requirements, recalls, ECG demands, and waste management

    Boost supply chain collaboration

    Integrate with PLM, MES and ERP applications as well as any SAP landscape - safeguarding migration to SAP S/4HANA, and supporting supplier/customer connectivity

    Read a success story

    Learn how Orion, a global pharmaceutical company, streamlined its packaging operations and supported business growth by implementing Loftware Smartflow

    当社製品

    The right choice
    for your business

    ラベリングLoftware Cloud Enterprise

    業界をリードするクラウドベースのラベル管理プラットフォーム、Loftware Cloud でラベリング業務を管理・拡大しましょう。ラベル管理を一元化し、コラボレーションを強化し、グローバルなサプライチェーン全体でのコンプライアンスを徹底します。

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    アートワーク管理Loftware Smartflow

    自動化されたワークフロー、組み込みの承認プロセス、リアルタイムのコラボレーションにより、パッケージングのアートワーク管理を効率化します。Loftware Smartflow を活用して、市場投入までの時間を短縮し、規制遵守を確実なものにします。

    Smartflow の実際の動作をご覧ください
    臨床試験Loftware Cloud Clinical Trials

    業界で最も強力なクラウドベースのソリューションを活用し、臨床ラベル作成とブックレット管理の正確性とコンプライアンスを確保します。厳格な規制要件を満たすように設計され、複雑な臨床サプライチェーンに対応可能です。

    臨床ラベリングツールを表示

    Formulated to meet your labeling needs

    Staying ahead of compliance challenges

    Meeting regulatory labeling and identification compliance on a global scale while addressing regional nuances around language and symbologies is challenging. Pharmaceutical manufacturers, co-packers, and suppliers must comply to ensure drug/medicine integrity, patient safety, and market access and availability worldwide.

     

    Loftware’s solutions make sure you meet requirements, ensuring accuracy at every stage of compliance for standards and regulations including:

    FDA 21 CFR Part 11

    Electronic records and signatures for compliance in labeling

    DSCSA - Drug Supply Chain Security Act

    Serialization and traceability requirements

    EU Falsified Medicines Directive (FMD)

    Security features for anti-counterfeit and traceability

    Health Canada Labeling Requirements

    Label content and format for standards for Canadian market

    PIC/S GMP Guidelines

    Labeling requirements under Good Manufacturing Practice

    ISO 13485

    Labeling requirements for medical devices and pharma products

    China FDA (CFDA) Regulations

    Country-specific labeling standards for China

    WHO Good Manufacturing Practices (GMP)

    Global guidelines for labeling and packaging

    Additional resources