Save Time, Reduce Cost of Implementing a
Validated Labeling Solution

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

USDM Life Sciences - a leading global regulatory consulting firm in the life sciences industry-and Loftware have partnered to develop a Validation Accelerator Pack (VAP) to simplify compliance, increase productivity and minimize costs. The Loftware VAP enables pharmaceutical and medical device companies to quickly and cost-effectively implement and maintain a validated, compliant labeling solution.

The Loftware VAP complements Spectrum, the industry's most powerful labeling solution designed to address the unique complexities of labeling in the life sciences space. When paired with Spectrum's configurable workflow framework and eSignature capabilities, the Loftware VAP provides a jump-start towards validation and helps to facilitate 21 CFR Part 11, underscoring Loftware's ongoing commitment to pharmaceutical and medical device labeling.

As USDM's only VAP for an Enterprise Labeling Solution, the Loftware VAP provides a set of content-rich validation templates that are ready to be configured to reflect your implementation decisions:

  • Validation Plan
  • System Requirement Specifications
  • Functional Risk Assessment
  • Installation Qualification
  • Operational Qualification
  • Performance Qualification
  • Traceability Matrix
  • Validation Summary Report
  • Vendor Audit Report
  • 21 CFR 11 Assessment

The VAP templates are in MS Word and can be easily updated to include your specific information and project details.

To learn more about getting started with your Loftware VAP, contact us at

"The Loftware VAP helps life science companies meet regulatory challenges, while reducing validation time and costs up to 50%."
- Jay Crowley, Vice President
UDI Services and Solutions, USDM Life Sciences