nroze22 Requirements Test Matrix
Generate a comprehensive, categorized test case matrix from product requirements. Each test case is mapped to its source requirement and categorized by test type (automated, manual, UAT) for planning and execution.
When to Use
- PRD approved and stories created - need test coverage plan
- QA needs a master test list before sprint execution
- Preparing UAT test suites for CRO/sponsor users
- Building regression test suite for a new feature
- Validation planning (mapping tests to IQ/OQ/PQ)
Workflow
Step 1: Ingest Requirements
Accept input from:
- PRD text or Confluence URL
- Jira story keys (pull via Atlassian MCP)
- Pasted requirements or acceptance criteria
Step 2: Extract Testable Requirements
For each requirement, identify:
- Functional behavior to verify
- Edge cases and boundary conditions
- Error handling scenarios
- Regulatory/compliance requirements
- Performance expectations
- Security requirements
Step 3: Generate Test Case Matrix
Output as a table (CSV/spreadsheet-ready):
| TC-ID | Requirement Ref | Test Category | Test Title | Preconditions | Steps | Expected Result | Test Type | Priority | Automation Candidate | UAT Candidate | Validation Phase |
|-------|----------------|---------------|------------|---------------|-------|-----------------|-----------|----------|---------------------|---------------|-----------------|
Column Definitions
- TC-ID: Unique identifier (TC-[Feature]-[Number], e.g., TC-ENROLL-001)
- Requirement Ref: PRD section or Jira story key this traces to
- Test Category: Functional | Negative | Boundary | Security | Performance | Compliance | Integration | Accessibility
- Test Title: Clear, concise description of what is being tested
- Preconditions: System state required before test execution
- Steps: Numbered steps to execute (keep concise, 3-7 steps)
- Expected Result: Specific, observable, pass/fail outcome
- Test Type: Unit | Integration | System | E2E | Regression
- Priority: P1-Critical | P2-High | P3-Medium | P4-Low
- Automation Candidate: Yes | No | Partial (with reason)
- UAT Candidate: Yes | No (with audience: CRO, Sponsor, Site)
- Validation Phase: IQ | OQ | PQ | N/A
Categorization Rules
Automation Candidates (mark Yes when):
- Repeatable with consistent inputs/outputs
- Data-driven (same test, different data sets)
- Regression risk (core functionality that must always work)
- High-frequency execution (run every build)
- No subjective judgment required
- UI interactions follow predictable patterns
- API/service layer tests
- Database validation queries
Manual Testing Required (mark No when):
- Requires subjective visual assessment
- Complex multi-system workflow with timing dependencies
- Exploratory testing needed
- First-time validation of new functionality
- Usability evaluation
- Complex clinical workflow requiring domain judgment
UAT Candidates (mark Yes when):
- Business-critical workflow that end users must validate
- Clinical data entry patterns that site users perform daily
- Query management workflows (Data Managers)
- Monitoring and SDV workflows (CRAs)
- Report generation and data export (Sponsors, Biostatisticians)
- Any workflow where incorrect behavior impacts patient safety
Step 4: Generate Category Summaries
## Test Matrix Summary
### By Test Category
| Category | Count | Auto | Manual | UAT |
|-------------|-------|------|--------|-----|
| Functional | ... | ... | ... | ... |
| Negative | ... | ... | ... | ... |
| Boundary | ... | ... | ... | ... |
| Security | ... | ... | ... | ... |
| Performance | ... | ... | ... | ... |
| Compliance | ... | ... | ... | ... |
| Integration | ... | ... | ... | ... |
### By Priority
| Priority | Count | Auto | Manual | UAT |
|-------------|-------|------|--------|-----|
| P1-Critical | ... | ... | ... | ... |
| P2-High | ... | ... | ... | ... |
| P3-Medium | ... | ... | ... | ... |
| P4-Low | ... | ... | ... | ... |
### Automation Coverage
- Total test cases: [N]
- Automation candidates: [N] ([%])
- Manual only: [N] ([%])
- UAT required: [N] ([%])
### Traceability Coverage
- Requirements with test coverage: [N/total] ([%])
- Requirements without test coverage: [list any gaps]
Step 5: Regulatory Test Patterns
For clinical trial EDC, always include these test categories:
Audit Trail Tests:
- TC: Verify audit trail records user ID, timestamp, old value, new value for every data change
- TC: Verify audit trail captures reason for change
- TC: Verify audit trail is read-only (cannot be modified or deleted)
- TC: Verify audit trail is viewable by authorized users only
Electronic Signature Tests (21 CFR Part 11):
- TC: Verify signature requires username and password re-entry
- TC: Verify signature meaning is displayed before signing
- TC: Verify signed record is locked from editing
- TC: Verify re-signature is required after any change to signed data
- TC: Verify signature timestamp is system-generated (not user-editable)
Data Integrity Tests (ALCOA+):
- TC: Verify data is Attributable (who entered it)
- TC: Verify data is Legible (readable, permanent)
- TC: Verify data is Contemporaneous (timestamped at entry)
- TC: Verify data is Original (first recording preserved)
- TC: Verify data is Accurate (validation rules enforced)
Access Control Tests:
- TC: Verify role-based access for each user role
- TC: Verify site-level data segregation
- TC: Verify study-level access restrictions
- TC: Verify unauthorized access attempts are blocked and logged
Step 6: Output Formats
Offer the test matrix in multiple formats:
- Markdown table (default - paste into Confluence or Jira)
- CSV format (copy into Excel/Google Sheets)
- Zephyr Scale import format (if using Zephyr for test management)
Step 7: Offer Next Actions
- "Want me to generate detailed Playwright test scripts for the automation candidates? (use /playwright-test-generation)"
- "Shall I create UAT test scripts in business language? (use /uat-test-generation)"
- "Need a full test strategy document? (use /test-strategy)"
- "Want to sync these to Zephyr Scale? (use /zephyr-test-sync)"
- "Should I create the Jira stories for test execution? (use /prd-to-stories)"