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