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Mastering Periodic Review in GxP Environments

Mastering Periodic Review in GxP Environments

Leverage the advanced tools and methodologies offered by ProcessX for continuous improvement and excellence in GxP operations.

In regulated industries governed by good practices (GxP)—such as pharmaceuticals, biotechnology, and medical devices—companies must pay strict attention to product quality, patient safety, and compliance.

To ensure GxP computerized systems meet regulatory requirements and maintain product quality, process control, and data integrity, they undergo a three-stage validation process: process design, process qualification, and continued process verification. Periodic review is instrumental in confirming the validation status of qualified systems.

What is Periodic Review?

Periodic review of systems, processes, and procedures ensures that they remain in their validated state over time. Its purpose is to identify any changes made since the last review and determine the actions required to maintain a validated state.

The outcome may indicate that revalidation of a low-risk process is necessary, in which case validation activities are performed again.

What FDA, EU, and ISPE Guidance Says

U.S. Food and Drug Administration (FDA) 21 CFR 211.68(b) states, “Input to and output from the computer or related system of formulas or other records or data shall be checked for accuracy. The degree and frequency of input/output verification shall be based on the complexity and reliability of the computer or related system.”

European Union (EU) Good Manufacturing Practice (GMP) Annex 15 provides guidelines for facilities, systems, equipment, and processes—including cleaning—that should be periodically evaluated to confirm that they remain valid. Where no significant changes have been made to the validated status, a review documenting that facilities, systems, equipment, and processes meet the prescribed requirements fulfills the need for revalidation.

International Society for Pharmaceutical Engineering (ISPE) Good Automated Manufacturing Practice (GAMP 5) guidance addresses a risk-based approach to periodic review, the use of metrics and trends to determine fitness for use, and sample-based records reviews.

When to Conduct Periodic Reviews

The complexity, criticality, and usage of the computerized system helps to determine the frequency of periodic review. For example, new GAMP category 4 (configurable software) and GAMP category 5 (custom or bespoke software) may require an annual review, then more frequent reviews than off-the-shelf items.

For non-configurable systems, the initial review frequency may be every two years upon installation. Systems with low risk to patient safety and minimal impact on GMP requirements may not require periodic reviews. Whatever the case, it’s necessary to document the decision-making process and rationale for review frequency in a standard operating procedure (SOP).

When to Change the Frequency of Periodic Review

Without a doubt, periodic review is essential for continuous compliance, but it potentially imposes a significant burden on your regulated company. If procedural or technical controls are deemed high risk or prove to be ineffective, periodic review must happen more frequently.

After each periodic review task, there’s an opportunity to reassess the previously established frequency. If no significant issues are identified and controls prove effective, the frequency can be reduced.

What to Review in a Periodic Review

Periodic review involves analyzing information from incidences and changes. For example, user access reviews confirm that all active users are authorized in the system and verify the accuracy of their assigned roles. Audit trail reviews confirm authorized changes in the system.

It’s also important to address and close any data integrity issues, incidents, deviations, or corrective and preventive actions (CAPAs) generated during the review period and to validate the accuracy and completeness of data backups. These activities streamline the review process and ensure regulatory compliance.

Other Information related to business processes and computerized system validation (CSV) that supports periodic review include:

  • Policies, SOPs, and work instructions (WIs)
  • Compliance risk assessment reports
  • Previous periodic review reports
  • Current validation plan reports
  • Internal audit observations
  • System lifecycle documents
  • Change and configuration management records
  • Service management records
  • Error logs
  • Backup and restoration records

How ProcessX Simplifies Periodic Review in GxP Environments

Timely completion of periodic review tasks is critical for maintaining compliance and system integrity. The suite of capabilities in ProcessX ensures continuous compliance by leveraging pre-validated workflows, forms, and event-driven tasks. They also optimize automation features like e-Signature and audit trail tools.

ProcessX automates your regulatory applicability assessment and identifies the compliance requirements your organization is obligated to meet. It uses this assessment to help you determine periodic review frequency and scheduling.

With its regulated IT workflows, ProcessX enables the seamless integration of periodic review findings with quality records so that issues are promptly documented, monitored, and resolved through the CAPA process. Bolster your organization’s quality and compliance by using ProcessX to ensure thorough risk management and ongoing improvement and efficient management and oversight.

Additionally, ProcessX and ServiceNow store data elements in one place to drive generated tasks in predefined sequences to fulfill periodic review requirements. Increase the visibility of task-based actions using built-in notifications while improving communication and accountability.

The ProcessX dashboard gives you access to a comprehensive overview of completed periodic review tasks for systems and quality records. This insight into activities across your organization allows stakeholders to monitor and track review statuses, promote transparency and accountability, and achieve unprecedented operational excellence.

Why Wait Any Longer?

Embrace the principles of periodic review to safeguard patient safety and product quality while demonstrating the integrity of your GxP environments. Leverage the advanced tools and methodologies offered by ProcessX to optimize the periodic review process and maintain continuous improvement and excellence in GxP operations. Contact us today to get started.

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