Periodic Review of System Validation

System validation is key to maintaining compliance in GxP systems, but validation is not a once-and-done thing. Software updates as well as changes required to support manufacturing, clinical, or laboratory practices lead to periodic changes in the system, so it is important to conduct periodic audits to ensure that the system continues to perform for its intended purpose. These audits should include a review of the description of the system, critical subsystems, equipment, hardware, and software; effects of all date changes; all deviations and incidents; maintenance and calibration records; system logs, and any other performance trending; and regulatory requirements (old and new).

To ensure a thorough and successful validation review, we recommend the following steps:

Official Validation Documents: Organize and file specifications, plans, change logs, reports, operations manual, data retention, and other protocols.
Regulatory and Company Requirements: External and internal policies need to be written, reviewed, updated, approved by management, and distributed to stakeholders.
Assessment and Resolution of Validation Issues: Identify, discuss, address, and resolve issues from old validation reports.
Documentation: This needs to be ready for internal and external audits.
Updates and Modifications: Log updates and modifications that are required for the system.
Incident Tracking: Record all incidents.
Operation and Maintenance Procedures: Identify tasks completed by vendors, train users, and ensure that SOPs are defined.
Risk Assessment and Security: Create polices for internal and external systems, such as comprehensive risk and disaster recovery protocols.

Periodic validation review of systems is an important part of maintaining GxP compliance. Using this checklist, you can conduct a thorough review that ensures patient safety, product quality, and data integrity are protected.