Computer Systems Validation & Documentation
Xyntek’s experience in developing GMP validation protocols provides a valuable resource for your team in qualifying Computer-based Systems. Xyntek will work with your project engineering and quality assurance personnel to develop validation protocols to meet your specific needs
Xyntek’s experience in developing GMP validation protocols provides a valuable resource for your team in qualifying Computer-based Systems. Xyntek will work with your project engineering and quality assurance personnel to develop validation protocols to meet your specific needs. Xyntek’s validation services group has developed qualification protocols for computer-based systems including MES, SCADA Systems, Machine Vision Systems, Bar Code Systems, Inventory Management Systems, and other real time industrial and business computer systems.
Qualification Protocols
- Installation Qualification - inventories all the hardware and software components of your system and their proper installation and interconnection.
- Operational Qualification - verifies that the application on your computer-based system is functioning as expected in accordance with the latest system specification documentation.
- Performance Qualification - documents the performance of the computer-based system under actual operating conditions.
- Standard Operating Procedures
- Preventative Maintenance Schedules
Xyntek’s experience in Software Development Documentation provides a valuable resource for your team in qualifying Computer-based Systems. Xyntek’s validation services group has developed In-House SOP’s for computer-based system documentation. Documentation includes:
- Development Plan and Schedule
- Functional Requirements
- System Design Specification
- Validation Plan
- Test Plan
- Peer Review
- Design Review
- Change and Version Control
Xyntek Inc., 301 Oxford Valley Road, Yardley, PA 19067. Tel: 215-493-7091; Fax: 215-493-7094.