As per GxP requirements, systems shall be periodically evaluated to confirm that they remain in a validated state and are compliant with GMP. The purpose of the Periodic Review is to ensure that the computer system remains compliant with regulation, is fit for its intended use and satisfies company policies and procedures. Periodic Assessment and Review should also fit with the companies Operation Excellence / Continuous Improvement programme.
Some specific GMP areas, where appropriate, to cover when performing a periodic assessment and review:
- Overall GMP Compliance of the department
- System Change controls
- System Maintenance and Calibration
- Deviation, incident and problem Reports
- Non-conformance and CAPA
- System upgrade history
- System performance and Reliability
- Security and Access Control
- Risk Register & Mitigation Actions (RRMA)
- Validation Status
Mivado GlobalPerformance will help implementing and executing your periodic Review program based on quality risk assessment. We provide tools, techniques and end-to-end supports that helps to meet the Regulatory Requirements:
- Defining Periodic Review Approach
- Implementing System Categorization
- Scheduling Periodic assessment activities
- Executing Periodic Assessment and Review
