Deploy Checklist

Deploy Checklist Skill

Generate a comprehensive pre-deployment verification checklist for Talosix EDC system releases. Clinical trial systems are validated environments subject to 21 CFR Part 11 and GxP requirements. Every deployment must be verified before execution.

When to Use

• Before any deployment to staging, UAT, or production environments
• When preparing for a validated system release
• As part of change control execution

Checklist Generation

When asked to create a deploy checklist, produce a structured checklist covering all sections below. Tailor the checklist to the specific release scope provided by the user.

1. Change Control Verification

• Change request approved and documented in the change control system
• Change advisory board (CAB) approval obtained (production deployments)
• Risk assessment completed and reviewed
• All linked Jira tickets in "Ready for Deploy" status
• Deployment window confirmed and communicated

2. Validation Documentation Completeness

• Installation Qualification (IQ) protocol approved
• Operational Qualification (OQ) protocol approved
• Test scripts mapped to requirements (traceability matrix updated)
• All validation test cases executed and passed in pre-prod
• Deviations documented and dispositioned
• Validation summary report drafted (pending production execution)

3. Environment Readiness

• Target environment infrastructure verified (compute, memory, storage)
• Database migration scripts reviewed and tested in lower environment
• Environment configuration diff reviewed (env vars, feature flags)
• SSL certificates valid and not expiring within 30 days
• Third-party service dependencies confirmed operational
• Load balancer and DNS configuration verified
• Monitoring and alerting configured for new components

4. Data Backup and Recovery

• Full database backup completed and verified
• Backup restoration tested in isolated environment
• Audit trail data backed up separately
• Document/file storage snapshot taken
• Backup retention policy confirmed (minimum per regulatory requirements)
• Point-in-time recovery capability confirmed

5. Rollback Readiness

• Rollback plan documented and reviewed
• Rollback scripts tested in lower environment
• Database rollback procedure verified (forward-compatible schema changes preferred)
• Rollback decision criteria defined (go/no-go thresholds)
• Rollback communication plan prepared
• Maximum acceptable rollback window defined

6. Code and Artifact Verification

• Release branch/tag created and locked
• Build artifacts generated from tagged source
• Artifact checksums verified
• No unapproved commits since last validation
• Static analysis and security scans passed
• Dependency vulnerability scan completed
• Container images scanned (if applicable)

7. Stakeholder Notification

• Internal engineering team notified of deployment window
• QA team on standby for post-deploy verification
• Customer Success team notified (for customer-facing changes)
• Affected clinical sites notified (if downtime or workflow changes)
• Sponsor contacts notified (if study-impacting changes)
• Support team briefed on changes and known issues
• Release notes distributed to stakeholders

8. Go/No-Go Decision

• All checklist items above completed or explicitly waived with justification
• Go/no-go decision documented with approver names
• Deployment team roles assigned (deployer, verifier, rollback lead)
• War room / communication channel established
• Post-deployment verification plan ready

Output Format

Generate the checklist as a markdown document with:

• Release identifier and version number at the top
• Date and target environment
• Each section with checkboxes
• Space for sign-off names and timestamps
• Notes section for any deviations or waivers

Regulatory Context

Talosix EDC deployments must comply with:

• 21 CFR Part 11 (electronic records, electronic signatures)
• ICH E6(R2) GCP guidelines
• EU Annex 11 (computerized systems)
• GAMP 5 software lifecycle practices

Every deployment to a validated environment is a controlled change that requires documented evidence of verification.