How Can You Comply with Confidence?
If 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