Knowledge Base
Explore foundational concepts, inspection readiness guides, and regulatory frameworks.
Recent Articles
Traceability Matrix in Computerised System Validation
Learn how traceability matrices connect business requirements, risk assessments, specifications, validation testing and objective evidence throughout the lifecycle of validated pharmacovigilance systems.
Validation Testing in Pharmacovigilance: IQ, OQ, PQ and User Acceptance Testing
Learn how validation testing provides objective evidence that pharmacovigilance computerised systems are fit for their intended use through risk-based qualification and testing strategies.
User Requirements Specifications (URS) in Pharmacovigilance
Learn how to write effective User Requirements Specifications (URS) that form the foundation of successful validation projects and support inspection-ready pharmacovigilance systems.
Functional Specifications and Design Specifications in Pharmacovigilance
Learn how business requirements defined in the User Requirements Specification are translated into functional and technical system designs while supporting risk-based validation and regulatory compliance.
Signal Management & Benefit-Risk
22- What is a Safety Signal?
- Signal Tracking and Documentation
- Signal Prioritisation in Pharmacovigilance
- Signal Validation in Pharmacovigilance
- Signal Management
Risk Management Plans
14- RMP Lifecycle Management
- RMP Governance and Version Control
- Risk Minimisation Effectiveness Evaluation
- Safety Specification
- Risk Management Plans (RMPs)
PBRER
11- How to Write a PBRER
- Understanding the Structure of a PBRER
- Writing the Executive Summary in a PBRER
- Writing the Data in Summary Tabulations Section in a PBRER
- Writing the Worldwide Marketing Authorisation Status Section in a PBRER
Vendor Management
9- Vendor Oversight in Pharmacovigilance
- Vendor Risk Assessment in Pharmacovigilance
- Common Vendor Oversight Inspection Findings
- Vendor Audits in Pharmacovigilance
- Vendor Oversight for QPPVs
Audits & Quality Assurance
8- Risk-Based Audit Planning in Pharmacovigilance
- QPPV and Audit Oversight
- Pharmacovigilance Audits
- Common Pharmacovigilance Audit Failures
- Audit Programme Management in Pharmacovigilance
PSMF Management
8- What is a Pharmacovigilance System Master File (PSMF)?
- PSMF Inspection Readiness Checklist
- PSMF and QPPV Oversight
- Common PSMF Inspection Findings
- PSMF Maintenance and Change Control
Safety Operations
8- Medical Literature Monitoring in Pharmacovigilance
- EVDAS and Signal Detection in Pharmacovigilance
- EudraVigilance Metrics and KPIs for QPPVs
- XEVMPD Guide for Pharmacovigilance Professionals
- EudraVigilance Registration and Access Management
Pharmacovigilance Inspections
7- What is a Pharmacovigilance Inspection?
- Pharmacovigilance Inspections
- Inspection Interviews in Pharmacovigilance
- Inspection Hosting for QPPVs
- Inspection Readiness in Pharmacovigilance
Governance & Oversight
6- Pharmacovigilance Governance
- What is a Local Safety Officer?
- Deputy QPPV
- QPPV Metrics
- Global vs EU PSMF
Computerised System Validation
5- User Requirements Specifications (URS) in Pharmacovigilance
- Functional Specifications and Design Specifications in Pharmacovigilance
- Validation Testing in Pharmacovigilance: IQ, OQ, PQ and User Acceptance Testing
- Traceability Matrix in Computerised System Validation
- Computerised System Validation Plan