Regulatory & Compliance

How Can You Comply with Confidence?

regulatory-personas-buttons.pngIf you work in a Regulatory or Compliance department, you’re all about adhering to laws, regulations and standards to protect your company from fines, litigation, penalties, or worse.

You care about labeling because:

  • Regulations and standards like GHS, UDI, MDR, GS1, 21 CFR Part 11, FSMA, etc. mandate label requirements
  • Non-compliant labels lead to costly fines, returned products and possible lawsuits
  • Delays in making changes mean missed deadlines, unhappy customers and partners
  • Complying with global regulations adds complexity, increases risk of errors
  • Label review process is siloed or disjointed resulting in non-compliant product, fines, etc.
  • Multiple labeling solutions complicate auditing and validation projects

 

How Enterprise Labeling Helps

  • Ensure accuracy through integration with ERPs, PLMs, Regulatory DBs and other sources of truth
  • Review and approve labels systematically with an auditable workflow that also supports eSignatures
  • Own and manage your part of the label; make mass changes across multiple templates with layers in design
  • Make label changes quickly and easily—without relying on IT
  • Easily add color, pictograms, multiple languages, etc. often within the same template
  • Create dashboards and reports with insight into users, labels, audit data and more
  • Reduce validation time and cost by 50% with Spectrum Validation Accelerator Pack
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Download e-Book

This book is the definitive source on Enterprise Labeling for Dummies and non-Dummies alike! It offers an easy to understand explanation of Enterprise Labeling and how it can help a company streamline their supply chain processes through better labeling.

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With Loftware, we were able to standardize labeling across all Ferring entities. We’re now able to reduce mistakes on dynamic data printed on the labels and reduce template management time.

Ferring Pharmaceuticals, Jean-Francois Ardito, IT Project Manager

Source: TechValidate. TVID: 1E5-E65-5B5