Loftware Spectrum® Cloud Assurance

Now you can streamline the validation workload for a standardized Enterprise Labeling Solution while meeting evolving FDA and EU regulatory requirements.

USDM Life Sciences and Loftware have partnered to develop a Validation Accelerator Pack (VAP) to simplify compliance, increase productivity and minimize costs. The Loftware Spectrum VAP—leveraging the industry’s most powerful labeling solution—enables medical device companies to quickly and cost-effectively implement and maintain a validated, compliant labeling solution. In many cases, companies have reduced validation time and costs up to 50%.
  • Validation Plan
  • System Requirement Specifications
  • Functional Risk Assessment
  • Installation Qualification
  • Operational Qualification
  • Performance Qualification
  • Traceability Matrix
  • Validation Summary Report
  • 21 CFR 11 Assessment
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