Ensuring Compliance, System Integrity & Continuous Improvement

In pharmacovigilance (PV), deviations are any unplanned departures from established procedures or SOPs – whether related to case processing, literature screening, signal detection, or other PV activities. If not managed effectively, deviations can lead to non-compliance, inspection findings, and potential risks to patient safety.

EU GVP Module I requires Marketing Authorisation Holders (MAHs) to maintain a robust process for identifying, documenting, assessing, and addressing deviations across the PV system.

All deviations – regardless of their criticality – must be clearly documented, tracked, and assessed. A formal process for root cause analysis and the implementation of corrective and preventive actions (CAPAs) must be in place. The pharmacovigilance system must also ensure ongoing oversight, regular review, and effectiveness checks of implemented actions.

Additionally, deviation trends must be analysed and reported to the EU QPPV as part of the periodic PV system performance review.

In short: Deviation management is not optional – it’s a regulatory requirement and a cornerstone of your PV quality system.

Deviation Management in Pharmacovigilance

I support you in establishing an efficient and inspection-ready deviation management system – tailored to your PV operations and aligned with EU GVP.

Process Development & Implementation

Design and implementation of a deviation management framework that defines roles, responsibilities, timelines, and integration into your existing PV system.

Deviation Handling & CAPA Management

Design of structured workflows and documentation templates for consistent deviation recording, root cause analysis, and tracking of corrective and preventive measures – enabling transparency and traceability.

Audit & Inspection Readiness

Review of deviation records and CAPA documentation to ensure consistency with regulatory expectations and robust audit trails.

Training & Awareness Building

Team-specific training on deviation identification, documentation standards, CAPA workflows, and inspection readiness – tailored to PV-relevant activities.

My Services – Structured Deviation Management for Lasting Compliance

Your Benefits – Why Structured Deviation Handling Matters

✔ Regulatory Compliance & Risk Control

Ensure full alignment with EU GVP expectations and reduce the risk of findings or regulatory action.

✔ Process Integrity & Operational Efficiency

Standardised workflows increase clarity, accountability, and consistency in daily operations.

✔ Systematic Oversight

Maintain an accurate and up-to-date overview of deviation handling, follow-up actions, and overall system performance.

✔ Continual Improvement

Analyse deviation trends and CAPA effectiveness to identify weak spots and drive meaningful, long-term improvements in your PV system.

✔ Audit & Inspection Confidence

Demonstrate structured deviation handling, clear documentation, and proactive oversight – ready to withstand regulatory scrutiny.

Documenting deviations and CAPAs in a pharmacovigilance quality system

Need Support with Deviation Management in PV?

Let’s ensure your deviation process is compliant, inspection-ready, and fully integrated into your PV quality system.

Let’s discuss how I can help!

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