Maintenance of the qualified and validated status
After you've qualified the infrastructure (Microsoft Power Platform) and validated the applications (Dynamics 365 Guides and Power Apps), it's important to ensure that they are kept under control. The computer systems and infrastructure are dynamic in nature. Procedures must be in place to maintain the qualified/validated status when, for example, there are new system versions and infrastructure upgrades. These changes can directly or indirectly affect product quality, patient safety, data integrity, internal policies, regulatory compliance, or business.
The following internal procedures must be implemented to maintain the qualified/validated status:
- Change control: A process to ensure that all system changes are under control. It also ensures and defines your implementation strategy for change.
- Incident and problem management: Processes to ensure that any unplanned issues that could have an impact on patient safety, product quality, and data integrity are addressed before any harm occurs. A problem is related to the root cause of one or more incidents. Problems can be raised in response to a single significant incident or multiple related incidents.
- Corrective action and preventive action (CAPA): A process for investigating, understanding, and correcting deviations. It addresses the immediate impact of the issue and helps minimize the risk of recurrence.
- Training: A plan that defines relevant training according to user roles.
- Continuous monitoring: A process to establish monitoring activities that monitor and report system failures, availability, performance, configuration baseline, and information security issues.
- Backup and restore: A process for saving data, records, configurations, and software to help protect against loss of integrity or availability of the originals.
- System administration: A process that involves routine management and support of systems to ensure that they are running efficiently and effectively.
- Periodic review: A process to ensure that outcomes from review activities confirm all components of a system, and that the required support and maintenance processes are established and under control.
Maintenance of the qualified status for Microsoft Power Platform and the validated status for Guides and Power Apps is an activity that occurs on an ongoing basis. Adequate monitoring, documentation, and evaluation of program impacts help maintain the control condition.