Computer Systems Validation
Computer systems are used for nearly all systems, and at
Performance Validation we understand a successful commissioning
and qualification effort requires the integration of CSV with
mechanical commissioning and qualification activities.
Performance Validation stays current with the latest Good
Automated Manufacturing Practices (GAMP) and has successfully
developed and deployed the full suite of CSV documentation for
systems ranging in complexity from spreadsheet validation to
integrated platform solutions. With years of experience on both
the mechanical and automated aspects of a system, Performance
Validation is poised to deliver a right-sized and integrated
solution to assist you in meeting your CSV needs.
Services offered:
Performance Validation offers the following services related to Computer System Validation:
- Project Management and staffing of the entire CSV effort
- Validation Plan development & implementation
- Complete suite of GAMP documents: User Requirements through Summary Reports
- Source Code Review
- Traceability of Requirements through Testing
- Validation Report development
- Change Management
Experience:
Performance Validation has experience in performing CSV for the following types of systems:
- Systems
- Spreadsheets
- PLCs
- Servers
- Vision Systems
- DCS / SCADA
- BMS / UMS (e.g. Johnson Controls Metasys ®)
- HMI (e.g. Rockwell Automation RSView ®)
- Business Process Management (e.g. PTC Windchill®)