Analytics & Reporting

The Analytics page provides dashboards for monitoring quality performance, compliance status, trend analysis, report generation, and AI-powered predictive insights.

Note

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

---

View the analytics overview

1. On the left sidebar, select Analytics.
2. The Overview tab displays key metric cards:
   • Compliance Score — overall compliance percentage
   • 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
3. Below the main metrics, quick stats cards show document management, audit readiness, and system health indicators.
4. In the AI Predictive Insights section, review predicted quality risks with severity levels, confidence scores, and recommended actions.
5. Select Acknowledge on any insight to mark it as reviewed.

---

Monitor compliance scores

1. On the left sidebar, select Analytics.
2. Select the Compliance tab.
3. Review the Overall Compliance Score displayed with a color-coded indicator:
   • Green (90%+): excellent compliance
   • Yellow (70—89%): needs attention
   • Red (below 70%): requires immediate action
4. Scroll down to see the area breakdown with individual scores for:
   • Document Control
   • Training
   • Deviations
   • CAPAs
   • Audits
   • Suppliers
5. Review regulatory standard compliance status for ISO 9001, ISO 13485, GMP, and 21 CFR Part 11.

---

Analyze trends

1. On the left sidebar, select Analytics.
2. Select the Trends tab.
3. Select a metric to analyze from the options:
   • Deviations by Month
   • CAPA Closure Rate
   • Training Completion
   • Document Review Time
   • Supplier NCRs
4. Choose a time period: 30 Days, 90 Days, 6 Months, or 1 Year.
5. Review the chart showing the metric over the selected period, along with the current value, previous value, and change percentage with a trend indicator.

Tip

Use the 6-month or 1-year view to identify systemic patterns rather than short-term fluctuations.

---

Generate a report

1. On the left sidebar, select Analytics.
2. Select the Reports tab.
3. Select a Report Type:
   • Quality Overview
   • Deviation Trends
   • CAPA Effectiveness
   • Training Status
   • Supplier Performance
   • Audit Summary
4. Choose a Date Range using the period selector: Last 7 Days, Last 30 Days, Last 90 Days, Year to Date, or Custom.
5. For custom date ranges, set the start and end dates.
6. Choose an Output Format: PDF, Excel, or CSV.
7. Select Generate Report.
8. Once generated, select Download next to the report in the list below.

Tip

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

---

Review predictive insights

1. On the left sidebar, select Analytics.
2. Select the Insights tab.
3. Review the list of AI-generated insights, each showing:
   • A severity badge — Critical (red), Warning (yellow), or Info (blue)
   • A description of the predicted risk
   • A confidence score displayed as a progress bar
   • Recommended actions
4. Select Acknowledge on any insight to mark it as reviewed.

Caution

Predictive insights are AI-generated assessments based on historical data and patterns. Review them with qualified personnel and use them as one input among many in your decision-making process.

---

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

---

Tips

Tip

Use the Compliance tab before audits to quickly identify areas scoring below 90% and prioritize improvement efforts.

---

Practical example: Preparing analytics for a management review

Scenario: A Quality Director needs to compile quality performance data for the quarterly management review meeting required by ISO 13485 clause 5.6.

1. Navigate to Analytics and select the Compliance tab.
2. Note the Overall Compliance Score is 87% (yellow) — driven by a Training score of 74% and a Deviations score of 81%. Document Control and CAPAs are both above 90%.
3. Select the Trends tab. Choose Deviations by Month with a 6 Months timeframe. The chart shows deviations spiked in Month 3 (12 deviations vs. a baseline of 5) due to a raw material supplier issue, then returned to normal after a supplier CAPA was completed.
4. Switch to CAPA Closure Rate over the same period. The rate improved from 68% to 91%, confirming corrective actions are being closed on time.
5. Select the Reports tab. Generate a Quality Overview report with Year to Date range in PDF format.
6. Download the report for inclusion in the management review presentation.
7. Review the Insights tab. An AI insight flagged “Training requalification backlog increasing — 14 overdue assignments in Production” with a Warning severity and 82% confidence. Acknowledge the insight and add it to the management review agenda as an action item.

The management review package now includes compliance scores, trend analysis, a generated report, and a predictive risk item — all sourced directly from the Analytics dashboard.