Pharmaceuticals

Relief for Your Supply Chain Pain and Packaging Demands

Pharmaceutical companies continue to adapt to regulations like the FDA's Drug Supply Chain Security Act (DSCSA) and 21 CFR Part 11, as well as the EU's impending Falsified Medicines Directive (FMD). At the same time, their supply chain and packaging artwork processes need to operate more efficiently to compete in a growing marketplace. That's why more and more manufacturers are looking at pharmaceutical labeling and packaging artwork solutions to provide an edge in the face of these challenges.

Enterprise Labeling for Pharmaceuticals

The right Enterprise Labeling Solution lets companies throughout the Pharmaceutical supply chain turn labeling into a high-value, strategic element of the overall manufacturing and distribution process. By tightly integrating labeling with business processes you already use, you can:

  • Automate and centralize labeling to improve accuracy and eliminate complex, error-prone data replication
  • Respect and leverage “validated sources of record” to comply with regulatory, customer and CMO requirements
  • Easily build and securely share templates that comply with DSCSA, 21 CFR Part 11 ERES, EU FMD and other regulations  
  • Reduce label template maintenance with an integrated and automated solution
  • Quickly configure and update labels to meet evolving needs, expand into new markets
  • Save time and reduce cost of implementing a validated enterprise labeling solution
  • Extend labeling to distributors, suppliers, 3PLs to eliminate relabeling—save millions in inventory costs
  • Leverage standardized enterprise-wide labeling and GS1 standards to improve tracking of drugs, help prevent counterfeiting

Artwork Management for Pharmaceuticals

The right Artwork Management Solution lets Pharmaceutical companies take control of product packaging processes to easily meet regulatory requirements and manage high volumes of packaging labels and label changes. By implementing an out of the box, automated Artwork Management solution to manage packaging artwork throughout the product lifecycle, you can:

  • Integrate out of the box solution with business applications including ERPs and PLMs to leverage existing processes and access “sources of truth” for data to improve efficiency and accuracy and comply with customer, regional and regulatory requirements including, EU FMD and FDA 21 CFR Part 11
  • Ensure control and compliance with robust and reliable validation services that can be implemented quickly and efficiently to enable full version control, audit trail and traceability reports
  • Centralize content and integrate asset management to easily control unstructured data and versions including pack copy, warnings and serialization
  • Automate and track all of your workflows to keep a permanent record of all approval points, status, dates and users associated with the critical path
  • Ensure security and control to reduce errors, minimize risk and eliminate recalls by managing business processes and content with role-based access for stakeholders and supply chain partners
  • Address multi-lingual copy requirements with phrase/translation management capabilities offering library of common phrases, in any language, to ensure product has appropriate and accurate labeling for regions across an international landscape
  • Drive continuous improvements with insight into packaging artwork workflows with business intelligence and KPI reporting

No wonder many of leading Pharmaceutical companies rely on Loftware Solutions. Loftware Spectrum and Loftware Smartflow give you the power and flexibility to meet changing customer and regulatory requirements, improve response times and reduce overall costs - all while driving greater efficiencies across your extended supply chain. You can comply with customer and regulatory demands to keep product moving quickly —even across international boundaries.

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