“Computer system” is technically the hardware and software of a platform system. Around that you need to add application software, ancillary equipment, people and procedures to form a “computerized system.” This computerized system then runs within a company’s operating infrastructure (or on in the cloud if run within a cloud-hosted service environment).Each of these elements within the computerized system need to be either validated or qualified .
Infrastructure Qualification Plan
IT infrastructure qualification plan defines the framework to perform the initial exercise, and the ongoing work to ensure that the infrastructure remains in compliance.
IT infrastructure qualification plan includes: –
- Background and history.
- Roles and responsibilities.
- System description.
- Qualification approach – strategy to include:
- Creating user requirements specifications.
- Creating SOPs and policies.
- Installation/operational qualifications.
- Qualification summary reports
IT infrastructure qualification Tests: –
- Training
- Change control
- Access security
- Vendor support
- Virus protection
- Backup and restoration
- PC maintenance
- Periodic reviews
- Deviations/incidents
- Decommissioning network components
- Contingency planning and disaster recovery