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ROI CalculatorPeriodic Review is an organized process of review, carried out at regular intervals, aimed at reviewing a validated system, an equipment profile, a computerized software application, or SOP in order to confirm that it remains in a completely validated, compliant, and controlled state.
In sectors where there is a very high level of administrative or regulatory control, like pharmaceutical manufacturing, clinical laboratories, biotech manufacturing, and data handling processes in finance, getting through the validation process initially is just the start of the compliance lifecycle. After implementation of the automated system, the cleanroom's utility equipment, or production line, the process of change immediately begins. Updates will be made to the system software, preventive maintenance will be done on the equipment, the process manual will be updated, and little variations will inevitably occur. The Periodic Review is the governance tool used to verify that the changes have not impacted the baseline status of the system.
The fundamental purpose of conducting a Periodic Review is to ensure that any slight, unintended changes in the process, which may escape detection during routine change management efforts, are identified. The organization can then determine whether its systems are still aligned with its initial design and regulation requirements through the assessment of operational history within a specific period (normally 12-36 months, depending on a risk-based impact analysis). This approach is mandated by organizations around the world, including the FDA via 21 CFR Part 211 and EU GMP computerized systems via Annex 11. Failure to implement a Periodic Review Program exposes the organization to compliance risk since it would be unable to show its systems remain in a controlled state.
To produce an auditable Periodic Review report with objectivity, it is important for the validation team to consider multiple dimensions of operation in gathering data. Specifically,
Change Control History Tracking: Analyzing all change control log entries made since the last review to verify that all system changes have been tested, validated, and approved.
Deviation and Non-Conformance Trends: Analyzing all OOTs and system software issues to detect possible trends that may be indicative of equipment breakdowns or training deficiencies among operators.
Maintenance and Calibration History logs: Checking all PM and calibration histories to ensure that these operations were done within the stipulated timelines.
System Security and Access Control Audits: Analysis of user rights to verify that unique login credentials were upheld, and that administrative privileges were secure from breaches.
To complete a Periodic Review, there must be documentation approved by the system owner and the Quality Assurance team that indicates the system has been validated successfully. In case there is a trend identified in the review process, there must be an immediate implementation of the action through the Corrective and Preventive Action program, which includes re-validation.
Through this standardized review process, a business can ensure that the data integrity of its systems has been maintained, facilitate external audits, avoid surprises caused by downtimes of equipment, and establish a solid company base.
