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


What Our Customers Are Saying

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.
-Jean-Francois Ardito, IT Project Manager, Ferring Pharmaceuticals
Source: TechValidate. TVID: 1E5-E65-5B5

Latest Resources

Regulatory Labeling Guide: Best Practices to Sustain Compliance
Regulatory Labeling Guide: 6 Best Practices to Sustain Compliance
While different industries have different regulations, they all have common labeling challenges. Check out these best practices that will help you meet compliance while driving supply chain excellence.
Download Now
On-Demand Webinar: 5 Things You Need to Know About Global Med Device Labeling
Check out this webinar as USDM’s Jay Crowley discusses recent European Medical Device Regulations (MDR), as well as strict labeling demands from Russia, and how you can help ensure compliance.
View Now