Validation Accelerator Packs

Life science companies must manage global compliance standards and accelerating performance expectations to maintain a competitive advantage in the industry. Companies are looking to decrease costs, accelerate time to market, increase productivity, while achieving, simplifying and maintaining compliance. 

USDM Life Sciences provides a comprehensive enterprise solution to support US, EMEA, and Asian regulatory requirements for regulated applications (see list below). 

The USDM Life Sciences Validation Accelerator Packs (VAPs) and compliance methodology provides life science companies with an industry best practice tool to simplify compliance, increase productivity and minimize costs. The USDM VAPs have been used successfully in the industry for more than a decade.

The USDM Life Sciences VAPs are a complete set of validation document templates for each based on common, general requirements for life science companies and contain the following compliance documentation:

Computer System Validation Plan

  • Risk Assessment
  • Business Requirements Model
  • System Requirements Specification
  • Installation Qualification
  • Operational Qualification
  • Performance Qualification
  • Traceability Matrix
  • Standard Operating Procedure Checklist
  • Validation Summary Report

The USDM Life Sciences VAPs can decrease both validation time and validation costs by 50%, as well as provide for faster implementation time and better system performance. The VAPs provide an industry proven best practice approach to validation and compliance.

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