Analytics & Reporting

The Analytics page provides dashboards for monitoring quality performance, compliance status, trend analysis, report generation, and attention items derived from your records.

Note

The Analytics page requires the analytics.view_dashboard permission (granted to the Admin, QA_Team, User, Auditor and External Auditor roles — not to Trainee) and the Enterprise plan. On the Compliance and Growth plans the Analytics link is hidden from the sidebar; opening it directly shows an upgrade prompt rather than the dashboard. This applies to every page under Analytics, including Compliance Benchmarking.

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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. Select the Insights tab to see Attention Items. Each item is derived from a count of your own records — open high or critical deviations, CAPAs past due, and outstanding training assignments. Every item shows the count it came from, the rule that produced it, and suggested next steps.
5. Select Refresh at the top of the page to re-derive the list.

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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.
6. Select Manage Automations on the Workflow Automations card to open the automations page.

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Manage workflow automations

1. On the left sidebar, select Analytics.
2. Select the Compliance tab, then select Manage Automations on the Workflow Automations card.
3. The automations page lists the rules that trigger automatically on quality events — each row shows the rule’s name, description, how many times it has fired, and when it last triggered.
4. Select the switch on a row to enable or disable that rule. The change is saved immediately; refreshing the page confirms the new state.

Note

Enabling or disabling an automation requires the analytics.generate_reports permission (Admin or QA_Team) — viewing the Analytics dashboard alone does not allow changing automation state. Each toggle is recorded in the audit trail.

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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.

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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.

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Review attention items

1. On the left sidebar, select Analytics.
2. Select the Insights tab.
3. Review the list of attention items, each showing:
   • A category badge and a priority badge — high, medium, or low
   • The count it was derived from, such as “12 open high/critical deviations”
   • The rule that produced it
   • Suggested next steps
4. Select Refresh at the top of the page to re-derive the list.

Note

Attention items are not predictions and no model produces them. Each one is a fixed rule counted over your own records, which is why every item states both its count and its rule. They are a prompt to look, not an assessment.

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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 attention items	Admin, QA_Team
Download reports	Admin, QA_Team
Enable/disable a workflow automation	Admin, QA_Team (analytics.generate_reports)

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Tips

Tip

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

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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 attention item reads “14 incomplete training assignments” with a low priority, citing the rule “More than 5 outstanding training assignments”. 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 an outstanding-training item — all sourced directly from the Analytics dashboard.