Enrich your computer system validation efforts with ROQMetrics professional services.
Assessment of your current state GxP system for adherance to 21 CFR Part 11, good SDLC practices and more.
Management of your compliance projects to assure your projects stay on track and implemented efficiently while meeting business and quality objectives.
Manage the validation of your compliance projects to assue that solutions are implemented in compliance with regulations while meeting the requirements for intended use including:
- Validation Plans
- User Requirements Specifications
- System Specifications (Functional, Configuration, etc)
- Installation, Operational, and Performance Qualification
- Validation Reporting
Implement QMS, Complaints, Training Management and Document Management systems following SDLC standards while adhering to validation guidelines.
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