Stakeholder Alignment

Stakeholder Alignment

Create structured alignment documents for cross-functional initiatives at Talosix. Clinical trial EDC features often require coordination across engineering, regulatory, clinical operations, customer success, and commercial teams.

Workflow

1. Identify the Initiative: Get the feature/initiative name and scope from the user.
2. Map Stakeholders: Identify all involved teams and individuals.
3. Generate Documents: Produce the requested alignment artifacts.
4. Publish: Offer to create a Confluence page for shared access.

Document Types

1. RACI Matrix

Define Responsible, Accountable, Consulted, Informed for each workstream.

Talosix Standard Stakeholder Roles

• Product Management: Feature definition, prioritization, go-to-market
• Engineering: Design, development, code review, deployment
• QA / Validation: Test planning, IQ/OQ/PQ execution, validation documentation
• Regulatory / Compliance: 21 CFR Part 11 review, audit readiness, SOP updates
• Clinical Operations: Domain expertise, workflow validation, customer requirements
• Customer Success: Customer communication, training, UAT coordination
• Commercial / Sales: Positioning, pricing, competitive messaging
• Security / IT: Infrastructure, access control, penetration testing
• Documentation: User guides, release notes, help center updates
• Executive Sponsor: Budget approval, strategic decisions, escalation path

RACI Template

2. Decision Log

Track key decisions for audit trail and alignment.

Decision Categories for EDC Features

• Regulatory: Compliance approach, validation strategy, audit trail scope
• Technical: Architecture, data model, integration approach
• Product: Scope, phasing, MVP definition, UX approach
• Commercial: Pricing, packaging, customer rollout order
• Operational: Training, support model, documentation

3. Communication Plan

4. Alignment Meeting Agenda Template

## [Initiative] Alignment Meeting - [Date]

### Attendees
[List with roles]

### Agenda (30 min)
1. (5 min) Status update - what's changed since last meeting
2. (10 min) Open decisions requiring input
3. (10 min) Risks and blockers
4. (5 min) Action items and next steps

### Pre-Read
- [Link to PRD / design doc]
- [Link to Jira board]
- [Link to decision log]

### Decision(s) Needed
- [ ] [Decision 1]: Options A vs B, recommendation
- [ ] [Decision 2]: Go/no-go on [scope item]

5. Stakeholder Map

Categorize stakeholders by influence and interest:

         High Influence
              |
   Manage     |    Collaborate
   Closely    |    Closely
              |
Low Interest -+------------- High Interest
              |
   Monitor    |    Keep
              |    Informed
              |
         Low Influence

For each stakeholder:

• Name / Role: Who they are
• Quadrant: Collaborate / Manage / Inform / Monitor
• Key Concern: What they care about most (e.g., timeline, compliance, cost, UX)
• Communication Preference: Email, Slack, meeting, async doc review
• Potential Blocker?: Yes/No and mitigation

EDC-Specific Alignment Considerations

• Validation gates: QA and Regulatory must sign off before customer-facing releases
• Customer re-validation: Changes to validated features require customer notification and potential re-validation effort
• Audit trail: All decisions affecting data handling must be documented for regulatory inspections
• Change control: Feature changes after requirements freeze must go through formal change control
• Multi-study impact: Changes can affect active studies; rollout must be coordinated with customer study timelines