VAPs for EQM Systems
Quality Management systems provide benefits across broad functional business areas for many organizations, enabling them to implement automated, highly interactive quality processes tailored to align with their specific products and business practices. The efficiency and effectiveness of these holistic quality systems are improved through interactive integration with other existing enterprise-level software solutions.
USDM has developed a comprehensive solution to support Life Sciences companies with comprehensive testing of regulatory requirements for Sparta Systems TrackWise® system.
Our Validation Accelerator Package (VAP) provides validation assistance with core regulatory requirements for the following TrackWise® modules/functionality:
- Quality Management
- Document Management
- Audit Management
- Training Management
- CAPA
- Reporting
- OOS Tracking
- Change Management
- Investigations
- Observations
- Complaint Handling
USDM's Sparta Systems TrackWise documentation provides a pre-configured content rich set of templates, ready for customization to meet both domestic and international regulations. Our documentation templates include:
- Validation Plan
- User Requirements Template
- Risk Assessment
- Functional and Design Specification
- Installation Qualification
- Operational Qualification
- Performance Qualification Template
- Trace Matrix
- Validation Summary Report
USDM follows application development to identify upcoming patches and updates, and provides a full maintenance program for our TrackWise clients. Recommendations for required testing are made to ensure our clients an effective, efficient validation maintenance process.
USDM has a dedicated, experienced Sparta Systems TrackWise validation team that can customize the VAP templates and provide best practice consulting on regulatory compliance.
USDM works closely with its partners and vendors to identify upcoming patches and updates, and provides a full maintenance program for our Sparta Systems TrackWise VAP clients. Recommendations for required testing are made to ensure our clients an effective, efficient validation maintenance process.Equipped with over 10 years of experience and specialization in regulated business processes, our skilled team of Sparta Systems TrackWise validation professionals can provide your organization with innovative and streamlined alternatives to industry standards.
USDM has been successful across many Sparta Systems TrackWise validation projects around the globe and our best-in-class validation services coupled with proven and effective methodologies can give your organization the competitive advantage it needs to thrive in today's regulated environment.
To learn more about USDM and how we can assist with your compliance and business objectives, please contact:Rebecca Meledy
888.231.0816 x161
775.213.5943 (fax)
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"Simplify, Unify and Optimize your business & compliance needs with USDM"
