Guidelines for Pharmacovigilance System Validation

1) Purpose

The purpose of this SOP is to establish procedures for validating pharmacovigilance systems to ensure compliance with regulatory requirements and data integrity standards.

2) Scope

This SOP applies to personnel responsible for pharmacovigilance system validation, including IT personnel, pharmacovigilance managers, and quality assurance professionals.

3) Responsibilities

The Pharmacovigilance System Owner is responsible for overseeing system validation activities. IT personnel provide technical expertise and support during validation processes.

4) Procedure

4.1 System Requirements Definition

1. Define and document functional and technical requirements for pharmacovigilance systems based on user needs and regulatory guidelines.
2. Ensure alignment of system requirements with pharmacovigilance processes, data management practices, and reporting obligations.

4.2 Validation Planning

1. Develop a validation plan outlining objectives, scope, validation activities, timelines, and resource requirements.
2. Obtain approval for the validation plan from relevant stakeholders and regulatory authorities as applicable.

4.3 Installation Qualification (IQ)

1. Verify and document hardware and software installation specifications to ensure compatibility and functionality.
2. Conduct IQ tests to confirm proper installation and configuration of pharmacovigilance systems according to predefined requirements.

4.4 Operational Qualification (OQ)

1. Perform OQ tests to verify the operational functionality and performance of pharmacovigilance systems under simulated conditions.
2. Document OQ results and address any discrepancies or issues identified during testing.

4.5 Performance Qualification (PQ)

1. Execute PQ tests to validate the accuracy, reliability, and consistency of pharmacovigilance system outputs and functionalities.
2. Validate data integrity, system security measures, and compliance with regulatory requirements during PQ testing.

4.6 User Acceptance Testing (UAT)

1. Collaborate with end users to conduct UAT to assess system usability, functionality, and user interface design.
2. Address feedback and recommendations from UAT participants to enhance system usability and user satisfaction.

4.7 Validation Report

1. Compile validation documentation, including IQ, OQ, PQ test results, UAT findings, and validation summary reports.
2. Prepare a validation report summarizing validation activities, results, conclusions, and compliance status.

4.8 Validation Maintenance

1. Establish procedures for ongoing validation maintenance to ensure continued compliance with evolving regulatory requirements and system updates.
2. Monitor system performance, conduct periodic reviews, and implement corrective actions or updates as necessary based on validation findings.

4.9 Training and Documentation

1. Provide training to pharmacovigilance staff on validated system functionalities, use, and maintenance procedures.
2. Maintain up-to-date documentation of system validation activities, including validation plans, reports, and training records.

4.10 Continuous Improvement

1. Conduct periodic reviews and audits of pharmacovigilance system validation processes to identify opportunities for improvement and optimization.
2. Implement enhancements and updates to validation procedures based on lessons learned, technological advancements, and regulatory changes.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, IQ – Installation Qualification, OQ – Operational Qualification, PQ – Performance Qualification, UAT – User Acceptance Testing

6) Documents, if any

Validation plan, IQ/OQ/PQ/UAT test protocols, validation reports, training materials.

7) Reference, if any

EMA Guideline on Good Pharmacovigilance Practices (GVP) Module IV – Pharmacovigilance Inspections, FDA Guidance for Industry – Computerized Systems Used in Clinical Investigations.

8) SOP Version

Version 1.0