Release Notes

Release Notes Generator

Generate professional release notes for Talosix EDC platform releases, pulling data from Jira and git history. Produces multiple formats appropriate for different audiences.

Workflow

1. Gather Release Scope:

   • Search Jira for tickets in the release: fixVersion = "[version]" AND status = Done ORDER BY type, priority
   • Get details on each ticket using getJiraIssue
   • Ask user for the version number, release date, and any highlights to emphasize
   • Optionally: ask user to run git log --oneline [previous-tag]..[current-tag] and provide the output

2. Categorize Changes: Group tickets by type and impact.

3. Generate Release Notes in the requested format(s).

4. Publish: Offer to create Confluence page(s).

Change Categorization

Group all changes into these categories:

New Features

• Major new capabilities added to the platform
• New modules or workflows

Enhancements

• Improvements to existing features
• UX/UI improvements
• Performance improvements

Bug Fixes

• Defects resolved
• Categorize by severity: Critical, High, Medium, Low

Regulatory / Compliance

• Changes affecting validated system state
• Audit trail modifications
• 21 CFR Part 11 related changes
• Security patches

API Changes

• New endpoints
• Modified endpoints (backward compatible)
• Deprecated endpoints
• Breaking changes (major version only)

Known Issues

• Issues identified but not resolved in this release
• Workarounds if available

Format 1: Customer-Facing Release Notes

# Talosix EDC Release Notes - Version [X.Y.Z]
**Release Date**: [Date]

## Highlights
[2-3 sentence summary of the most impactful changes]

## New Features

### [Feature Name]
[1-2 paragraph description written for clinical users: CDMs, CRCs, monitors]
- What it does and why it matters
- How to access/enable it
- Which user roles can use it

## Enhancements

### [Enhancement Name]
- [Clear description of the improvement]
- [User benefit]

## Bug Fixes
- **[Area]**: [Description of fix in user-friendly language]. ([Ticket ID])

## Validation Impact Statement
The following changes affect the validated state of the system and may
require updates to your site-specific validation documentation:

| Change | Affected Area | Validation Impact | Action Required |
|--------|--------------|-------------------|-----------------|
| [Change] | [Area] | [IQ/OQ/PQ impact] | [Customer action] |

**No validation impact**: The following changes do not affect the validated
state: [list minor fixes/cosmetic changes].

## Compliance Notes
- All changes in this release maintain compliance with 21 CFR Part 11,
  ICH E6(R2) GCP, and EU Annex 11 requirements.
- Audit trail coverage: [Confirm all new features include audit logging]
- Electronic signature workflows: [Any changes noted]

## Upgrade Notes
- **Downtime Required**: [Yes/No, expected duration]
- **Data Migration**: [Yes/No, details]
- **Configuration Changes**: [Any admin actions needed post-upgrade]
- **Browser Compatibility**: [Any changes to supported browsers]

## Known Issues
- [Issue description] -- Workaround: [workaround]. Fix targeted for [version].

## Getting Help
Contact Talosix Support at [support channel] for questions about this release.

Format 2: Internal Release Notes

# Internal Release Notes - Version [X.Y.Z]
**Release Date**: [Date]
**Release Manager**: [Name]
**QA Sign-off**: [Name, Date]
**Regulatory Sign-off**: [Name, Date]

## Release Summary
- Total tickets: [N]
- New features: [N]
- Enhancements: [N]
- Bug fixes: [N] (Critical: [N], High: [N], Medium: [N], Low: [N])
- Story points delivered: [N]

## Detailed Change Log

### [JIRA-123]: [Title]
- **Type**: Story / Bug / Task
- **Priority**: [Priority]
- **Component**: [Component]
- **Developer**: [Name]
- **QA**: [Name]
- **Description**: [Technical description]
- **Validation**: [IQ/OQ/PQ scripts updated: Yes/No, Script IDs]
- **Rollback Plan**: [How to revert if needed]

## Deployment Checklist
- [ ] Database migrations executed
- [ ] Configuration changes applied
- [ ] Feature flags set
- [ ] Cache cleared
- [ ] Integration endpoints verified
- [ ] Monitoring alerts configured
- [ ] Smoke tests passed

## Customer Communication Plan
- [ ] Release notes published to help center
- [ ] Email notification sent to admins
- [ ] CS team briefed
- [ ] Training materials updated

## Metrics to Watch Post-Release
- Error rates (compare to pre-release baseline)
- Page load times
- Support ticket volume
- Feature adoption (for new features)

Format 3: Regulatory Release Documentation

# Software Release Record - Version [X.Y.Z]

## Release Identification
- **Version**: [X.Y.Z]
- **Build**: [Build number]
- **Release Date**: [Date]
- **Previous Version**: [X.Y.Z-1]

## Change Summary
[List all changes with traceability to requirements]

| Change ID | Description | Requirement | Risk Assessment | Test Evidence |
|-----------|-------------|-------------|-----------------|---------------|
| [JIRA-ID] | [Description] | [REQ-ID] | [Risk level] | [Test script IDs] |

## Validation Summary
- **Test Scripts Executed**: [N]
- **Test Scripts Passed**: [N]
- **Test Scripts Failed**: [N] (with deviation references)
- **Regression Tests**: [Scope and results]

## Risk Assessment
- Impact on data integrity: [Assessment]
- Impact on electronic records/signatures: [Assessment]
- Impact on audit trail: [Assessment]
- Impact on access controls: [Assessment]

## Approval
| Role | Name | Signature | Date |
|------|------|-----------|------|
| QA Manager | | | |
| Development Lead | | | |
| Regulatory | | | |
| Product Owner | | | |

Tips

• Write customer-facing notes in plain language; avoid technical jargon
• Always include the validation impact statement for regulated customers
• Flag breaking changes prominently
• For security fixes, describe the improvement without exposing vulnerability details
• Include Jira ticket IDs for traceability