Validation PackagesLife 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 provides a comprehensive enterprise solution to support US, EMEA, and Asian regulatory requirements for regulated applications (see list below).
The USDM 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 over 8 years.
The USDM 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
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, ...
In the life science industry, it is important that clients define and document a consistent approach for implementation and validation of computerized systems. A vast number of Standard Operating Proc...
USDM has been paving the way for life sciences companies to take advantage of the effeciencies of validation packages- for over a decade. As we reflect back on the journey to ensure a proper level of...