Investigation

Need for Investigation

An investigation is a systematic, regulated process for identifying and correcting deviations, defects, or non-conformances to maintain product quality, safety, and regulatory compliance. Pharmaceutical investigations are critical to comply with regulatory expectations, as every OOS, OOT, deviation, or batch failure must be thoroughly examined and documented. A structured, risk-based approach ensures true root cause identification, effective CAPA, and adherence to data integrity principles. Without it, companies risk regulatory findings, product recalls, and patient safety concerns, making a robust investigation process essential for compliance, quality, and trust.

How it Benefits  

Process Diagram

Event Identification and Investigation logging

Acknowledging the deviation, complaint, OOS, or other quality events and initiaton of the investigation

Define Problem & Collect Data

Collect relevant data, records, and evidence; clearly define the problem including context from linked events if any.

Root Cause Analysis (RCA)

Use systematic tools (5 Whys, Fishbone) to analyse all relevant evidence to determine the root cause, considering links to other events if present.

Impact & Risk Analysis

Evaluate the risk and impact on product quality, compliance, and patient safety, including the cumulative effect of linked events.

CAPA Planning & Implementation

Define and implement corrective and preventive actions that addresses the root cause.

Effectiveness Check & Closure

Confirm actions resolved the issue, perform Effectiveness checks and close out documentation.

Investigation with QEdge

Root Cause Analysis with Investigation Tools: Integrated tools such as 5 Whys and Fishbone diagrams help systematically analyse root causes directly within the platform.
CAPA Integration: Following root cause, CAPA are triggered and managed, ensuring corrective and preventive actions are implemented, tracked, and verified for effectiveness.
Real-Time Monitoring & Alerts: Timely notifications and dashboards reflect investigation status, pending reviews, and CAPA progress, enabling proactive management.
Cross functional collaboration: Collaboration among QA, QC, production, and regulatory teams through role-based access and shared documentation environments.
Regulatory Compliance: Compliance with FDA 21 CFR Part 11, EU Annex 11, and other relevant regulations by providing digitized signatures, audit trails and controlled access.

Results of Implementation

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faster root cause identification

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reduction in investigation closure cycle times

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reduction in “human error” misclassifications

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fewer production delays due to faster investigation turnaround

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