Corrective and Preventive Action (CAPA) management is a cornerstone of every functioning pharmacovigilance (PV) quality system. According to EU GVP Module I, Marketing Authorisation Holders (MAHs) must implement a structured and traceable approach for identifying, documenting, and addressing non-compliances or quality issues within the PV system.

CAPA management plays a central role in:

Resolving findings from audits, inspections, and deviation reports
Preventing recurrence through root cause-driven actions
Strengthening the long-term performance and reliability of the PV system
Demonstrating proactive quality oversight during authority inspections
Supporting continuous improvement in line with EU GVP expectations

A robust CAPA system is not just a regulatory obligation - it is key to sustainable compliance and quality assurance in daily operations.

CAPA Management in Pharmacovigilance

Ensuring Compliance, System Improvement & Inspection Readiness

Why Is CAPA Management Essential in Pharmacovigilance?

A compliant CAPA workflow includes the following core elements:

Issue Detection & Documentation

Findings from audits, inspections, deviations, and other sources must be formally recorded and evaluated.

Root Cause Analysis (RCA)

A structured RCA is conducted to understand the true cause of the issue - enabling targeted, effective actions.

Definition of Corrective & Preventive Actions

Realistic and targeted CAPAs are defined, with clear ownership, timelines, and expected outcomes.

Implementation & Tracking

All actions are implemented within agreed timelines and tracked in a transparent and auditable manner.

Effectiveness Evaluation

A dedicated follow-up ensures that CAPAs are not only implemented, but truly effective - reducing the risk of recurrence.

The CAPA Process – From Identification to Effectiveness Check

Digital CAPA process in pharmacovigilance with document control and effectiveness checks

My Services

Expert Support Across the CAPA Lifecycle

CAPA Process Design & Integration

Development or optimisation of your CAPA process -tailored to your PV system.

Root Cause Analysis & Action Planning

Support in conducting Root Cause Analysis (RCA) and defining practical, compliance-focused CAPAs.

CAPA Implementation & Oversight

Monitoring implementation timelines, responsibilities, and ensuring traceable documentation.

I support you throughout the entire CAPA management process - from process setup to execution and effectiveness review.

Effectiveness Review & CAPA Closure

Support in evaluating CAPA success, documenting follow-up outcomes, and ensuring timely, justified closure.

Inspection-Ready Documentation & Training

Ensuring documentation quality and team awareness for regulatory inspections.

Your Benefits

Sustainable Compliance Through Effective CAPAs

✔ Full Regulatory Alignment

Your CAPA process meets EU GVP expectations - documented, traceable, and inspection-ready.

✔ Repeated Findings Avoided

Effective actions prevent recurrence - strengthening your quality system and audit outcomes.

✔ Clear Responsibilities & Deadlines

CAPAs are assigned, monitored, and completed on time - with full visibility for internal stakeholders and the EU QPPV.

✔ Practical, Scalable Solutions

Actions that are not only compliant, but realistic, implementable, and tailored to your organisation.

✔ Lasting Quality Improvement

Your PV system becomes stronger with every CAPA - building operational consistency and trust in regulatory interactions.

Need expert support in CAPA implementation and management?

Let’s discuss how I can assist you!

Get in Touch