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Quality Event Management

End-to-end quality event management

Enable effective quality event management

Managing quality events like nonconformances and deviations effectively can drive improvement and strengthen organizational outcomes.

Quickly Identify Quality Events

Dot Compliance enables early detection and reporting of quality events through automated alerts and centralized tracking. Teams can log events in real time, categorize them by severity, and initiate investigations immediately. This proactive approach prevents minor issues from escalating and helps maintain product quality and regulatory compliance.

Gain Accurate Root Cause Analysis

Built-in investigation tools and guided workflows support consistent root cause analysis, ensuring issues are fully understood before corrective or preventive actions are taken. Dot Compliance links events to related records such as CAPAs, training, and documents to provide full context during investigations. This connection helps teams identify true root causes and implement effective long-term solutions.

Ensure Efficient Investigation

Automated workflows streamline every stage of the investigation process—from event capture to resolution—reducing manual effort and cycle times. Integrated data gives quality teams complete visibility into open and closed events, helping them track progress, assign ownership, and verify effectiveness. This efficiency lowers costs, improves responsiveness, and supports continuous quality improvement.

Dot Compliance’s AI-powered, fully validated eQMS provides organizations with the ability to manage quality events so they are identified and recorded. This includes nonconformances, deviations, or incidents that could affect the quality or the reliability of records or tests to be investigated and resolved.

Why Dot Compliance Quality Event Management

Demonstrate consistency and control

Easily document all events and processes to determine the level of priority to assess, triage and escalate when necessary.

Automate the step-by-step process

Dot Compliance provides pre-defined reports for initiating any possible quality event investigation. The process is supported by the system, from initiation and investigation, to review, approval and closure in compliance with CFR 21 Part 11.

Streamline processes through Integration

When quality events are integrated with other quality records, such as CAPA and complaints, you can reduce errors and subsequent corrections, and improve quality event traceability.

End-to-end view of quality events

Improve visibility into your organization’s quality health through reporting and trending.

Identify trends in your quality data

Collecting quality information through investigations helps organizations put together intelligent information that supports improvements in existing processes, higher operational efficiency, and lower recurrence of quality events.

The eQMS that keeps you one step ahead

Dot Compliance is the industry’s first AI-powered eQMS, built to get you up and running fast – and to give you the insights to drive quality efficiently.

Smart solutions for life sciences companies at every stage

Meet the eQMS that evolves with you, from setting a foundation with core processes to the industry’s most sophisticated AI quality and compliance intelligence.