How do you monitor and maintain the performance of your software system after PQ is completed?

Periodic Validation reviews of the systems are most important to monitor the metrics of the performance of the system after the completion of the PQ.

Periodic reviews are a valuable method for ensuring that a system remains compliant with regulations. These reviews offer independent assurance to senior management that effective controls are in place and functioning correctly around the system under review. They also serve to identify any controls that may not be working as intended, allowing for improvement and the elimination of identified weaknesses. It's important to note that the impact of these findings may apply to a single computer system or to all systems. At the end of the process, all findings, observations, and conclusions should be thoroughly documented.

VSR should define the frequency for periodic reviews. Periodic reviews frequency of any system depends on the GAMP category of that system and its impact on the business.

In my experience, change control plays a critical role in ensuring that a system remains validated. When a change is proposed, we conduct a thorough impact assessment to understand how it might affect the validated state of the system. We then follow a structured process, including testing and validation, to confirm that the change doesn't compromise the system's intended functionality, data integrity, and regulatory compliance. Additionally, all documentation and evidence related to the change are carefully maintained to demonstrate its validation status during audits and inspections.

Yes, performance monitoring is a very helpful method. It helps keep your software running smoothly. They predict when you need more resources, work with different systems, store past data for review, and can be tailored to your software's needs. Some even use smart technology to spot problems before they happen, keeping your system dependable and fast.

Performance monitoring or effectiveness check is an important part of the validation process. This ensures that system is still working as expected.

An untrained user operating a fully validated system without proper procedural controls poses as high a risk to patient safety, product quality, and data integrity as using an invalidated system. Therefore, it's important that system users receive proper training

Training should be completed before PQ is started. Training should be completed as part of system familiarisation and all the required procedures should be approved before operation qualification is completed or as part of OQ. Monitoring of system status should be performed via Quality Management system.

Implementing a robust backup and restore process is crucial. Here are the key steps: Risk Assessment: Identify critical data, systems, and processes through a thorough risk assessment. Backup Strategy: Develop a strategy for backups, specifying their frequency, type, storage locations, and security measures. Restoration Plan: Create a detailed restoration plan, including steps for data recovery in case of loss or corruption. Personnel Training: Train responsible staff in backup and restoration procedures and technology. Conduct periodic tests to validate the process. Monitor and Review: Regularly monitor and review the process, including testing and validating backups and restoration procedures

In many organizations, the first point (periodic reviews) also aligns with the operational excellence and continuous improvement program.