Validation Accelerator Packs for Clinical and Safety Systems
Electronic submissions systems manage both paper and electronic submissions to regulatory agencies both within the United States and internationally.
Extedo and USDM have partnered to provide a comprehensive solution to support Life Sciences companies in regulatory requirements for Extedo’s eCTDmanager.
Our Validation Accelerator Package (VAP) provides validation assistance with core regulatory requirements for the following eCTDmanager functionality:
- Paper publishing
- Electronic publishing
- Document management
- System Interfaces
USDM’s eCTDmanager 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 works closely with Extedo to identify upcoming patches and updates, and provides a full maintenance program for our eCTDmanager clients. Recommendations for required testing are made to ensure our clients an effective, efficient validation maintenance process.
USDM has a dedicated, experienced eCTDmanager validation team that can customize the VAP templates and provide best practice consulting on regulatory compliance.
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”
