Analytics & Reporting

The Analytics module provides a comprehensive view of your organization’s quality performance. It includes real-time dashboards, compliance scoring, trend analysis, report generation, and AI-powered predictive insights.

What You Can Do

• View key metrics — Monitor compliance scores, training completion, quality issues, and equipment status at a glance
• Track compliance — See compliance scores by area and regulatory standard
• Analyze trends — Chart quality metrics over configurable time periods
• Generate reports — Create formatted reports in PDF, Excel, or CSV
• Get predictive insights — Review AI-generated predictions about potential quality risks

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Analytics Dashboard

Accessing Analytics

1. Navigate to Analytics from the main menu.
2. The main analytics page displays an overview of key metrics.

Note

The Analytics module requires the Admin or QA_Team role, or the analytics.view_dashboard permission.

Key Metrics Overview

The main dashboard displays four primary metric cards:

• Compliance Score — Overall compliance percentage across all areas
• Training Completion — Percentage of training assignments completed on time
• Quality Issues — Count of active deviations and open CAPAs
• Equipment Status — Equipment calibration and maintenance status

Quick Stats

Below the main metrics, quick stats cards show:

• Document Management — Total documents, pending reviews
• Audit Readiness — Audit preparation status
• System Health — Overall system performance indicators

AI Predictive Insights

The dashboard includes an AI-powered insights section showing:

• Predicted quality risks with severity levels (Critical, Warning, Info)
• Confidence scores for each prediction
• Recommended actions to mitigate risks
• An Acknowledge button to mark insights as reviewed

Quick Actions

Use the quick action buttons to jump directly to:

• Reports
• Automations
• Predictive Analytics

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Analytics Sub-Dashboard

KPI Grid

Navigate to Analytics > Dashboard to see a detailed KPI grid with six cards:

1. Total Documents — Count of all documents in the system
2. Active Deviations — Number of currently open deviations
3. Open CAPAs — Count of unresolved corrective and preventive actions
4. Training Compliance — Percentage of training requirements met
5. Supplier Score — Average supplier quality rating
6. Equipment Due Calibration — Count of equipment items due for calibration

Quick navigation links are provided to jump to Reports, Trends, Compliance, Predictive, and Automations pages.

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Compliance Monitoring

Viewing Compliance Scores

1. Navigate to Analytics > Compliance.
2. The Overall Compliance Score is displayed prominently with a color-coded circle:
   • Green (90%+): Excellent compliance
   • Yellow (70—89%): Needs attention
   • Red (below 70%): Requires immediate action

Area Breakdown

Compliance is broken down across six quality areas, each with its own score and progress bar:

• Document Control — Document lifecycle compliance
• Training — Training program compliance
• Deviations — Deviation handling compliance
• CAPAs — CAPA process compliance
• Audits — Audit program compliance
• Suppliers — Supplier quality compliance

Regulatory Standards

The compliance page also shows status against major regulatory frameworks:

• ISO 9001 — Quality Management Systems
• ISO 13485 — Medical Device Quality Management
• GMP — Good Manufacturing Practices
• 21 CFR Part 11 — Electronic Records and Signatures

Each standard displays a compliance status badge (Compliant, Partial, or Non-Compliant).

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Trend Analysis

Viewing Trends

1. Navigate to Analytics > Trends.
2. Select a metric to analyze:
   • Deviations by Month
   • CAPA Closure Rate
   • Training Completion
   • Document Review Time
   • Supplier NCRs (Non-Conformance Reports)
3. Choose a time period:
   • Last 30 Days
   • Last 90 Days
   • Last 6 Months
   • Last 1 Year

Reading Trend Data

Each trend view shows:

• A chart visualizing the selected metric over the chosen period
• Current value — The most recent data point
• Previous value — The comparison value from the prior period
• Change percentage — The difference between current and previous, with a trend badge indicating improvement or decline

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Report Generation

Creating a Report

1. Navigate to Analytics > Reports.
2. Select a Report Type:
   • Quality Overview
   • Deviation Trends
   • CAPA Effectiveness
   • Training Status
   • Supplier Performance
   • Audit Summary
3. Choose an Output Format:
   • PDF
   • Excel
   • CSV
4. Set a Date Range using the start and end date pickers.
5. Click Generate Report.

Managing Reports

• Previously generated reports appear in a list below the generation form.
• Each report shows its name, format, generation date, and status badge.
• Click Download to save a report to your local machine.

Tip

Schedule regular report generation (such as monthly Quality Overview reports) to maintain consistent documentation for audits and management reviews.

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Predictive Analytics

Viewing Predictions

1. Navigate to Analytics > Predictive.
2. Review the list of AI-generated insights.

Understanding Insights

Each prediction includes:

• Severity badge — Critical (red), Warning (yellow), or Info (blue)
• Description — What the AI has identified as a potential risk
• Confidence score — Displayed as a progress bar showing how certain the prediction is
• Recommended actions — Specific steps to address the predicted risk

Generating New Insights

1. Click the Generate Insights button to request a fresh analysis.
2. The AI analyzes current quality data, trends, and patterns.
3. New insights appear in the list when processing completes.

Caution

Predictive insights are AI-generated assessments based on historical data and patterns. They should be reviewed by qualified personnel and used as one input among many in your decision-making process.

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Permissions

Action	Required Role
View analytics dashboards	Admin, QA_Team, or analytics.view_dashboard permission
Generate reports	Admin, QA_Team
View predictive insights	Admin, QA_Team
Download reports	Admin, QA_Team

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Tips

Tip

Use the Compliance page before audits to quickly identify areas that need attention. Focus on any area scoring below 90% to prioritize improvement efforts.

Tip

The Trend Analysis feature is most valuable when comparing data over longer periods. Use the 6-month or 1-year view to identify systemic patterns rather than short-term fluctuations.

Tip

Export reports in Excel format when you need to perform additional analysis or create custom visualizations outside the system.