| name | deploy-plan |
| description | Create deployment plans for validated GxP environments including validation impact assessment, pre-deployment checklists, deployment steps with rollback criteria, post-deployment verification, and GxP documentation. |
Deployment Plan for Validated Environments
Purpose
Create deployment plans for releasing software changes to Talosix validated EDC production environments. Deployments to GxP systems require formal planning, validation impact assessment, documented execution, and post-deployment verification to maintain the validated state.
When to Use
- Any deployment to production GxP environments
- Deployments to staging/pre-production environments used for validation
- Infrastructure changes affecting validated systems
- Database changes (schema, data migration)
- Configuration changes to production
- Emergency hotfix deployments
Deployment Plan Document Structure
Header
DEPLOYMENT PLAN
Document ID: DP-[RELEASE]-[SEQ]
Release: [Release identifier / version]
System: [System name]
Target Env: [Production / Staging / DR]
Planned Date: [DATE]
Planned Window: [START TIME - END TIME, TIMEZONE]
Author: [Name, Role]
Technical Lead: [Name]
QA Approver: [Name]
System Owner: [Name]
Related Documents:
- Change Request: CR-[ID]
- Validation Protocol: [ID] (if applicable)
- Release Notes: [ID]
Section 1: Release Summary
Release Version: [X.Y.Z]
Changes Included:
| Change ID | Description | Type | Risk Level |
|-----------|------------|------|------------|
| CR-XXX | [Brief description] | Feature/Fix/Config | High/Med/Low |
Changes Excluded / Deferred:
| Change ID | Description | Reason for Deferral |
|-----------|------------|-------------------|
Section 2: Validation Impact Assessment
Evaluate each change against validation criteria:
| Change ID | Affects Validated Function | Revalidation Required | Test Scope | Validation Docs Updated |
|-----------|--------------------------|----------------------|-----------|----------------------|
Validation Impact Categories
No Impact - Change does not affect any validated functionality.
- Cosmetic changes with no data handling impact
- Internal refactoring with identical external behavior (confirmed by regression testing)
Minor Impact - Change affects validated functionality but within existing validated scope.
- Regression testing required
- Existing test cases re-executed
- No new validation documentation required
Major Impact - Change extends or modifies validated functionality.
- New or updated validation protocols required
- New test cases required
- Traceability matrix update required
- Validation summary report addendum required
Critical Impact - Change affects core GxP functions (audit trail, e-signatures, access controls, data integrity).
- Full validation protocol execution required
- Independent QA verification required
- Regulatory notification assessment required
Section 3: Pre-Deployment Checklist
Complete all items before deployment begins:
Approvals:
[ ] Change request approved by CCB
[ ] Deployment plan approved by QA
[ ] Deployment plan approved by System Owner
[ ] Deployment window confirmed (no conflicts with active studies)
[ ] Study teams notified of planned downtime
[ ] Client notification sent (if required)
Technical Readiness:
[ ] All code changes merged to release branch
[ ] Release build created and tagged in version control
[ ] Build artifacts verified (checksums match)
[ ] Release notes finalized
[ ] Database migration scripts reviewed and tested
[ ] Configuration changes documented
Testing Readiness:
[ ] All validation testing complete in staging/pre-prod
[ ] Validation test results reviewed and approved
[ ] Regression testing complete
[ ] No open critical or high defects
[ ] UAT sign-off obtained (if applicable)
[ ] Performance testing complete (if applicable)
Environment Readiness:
[ ] Production environment health verified
[ ] Database backup completed and verified
[ ] Application backup completed
[ ] Configuration backup completed
[ ] Monitoring alerts acknowledged or silenced for window
[ ] Support team on standby
Rollback Readiness:
[ ] Rollback procedure documented and reviewed
[ ] Rollback tested in staging (for major releases)
[ ] Rollback decision criteria defined
[ ] Rollback authorization chain confirmed
[ ] Database rollback scripts prepared and tested
Documentation Readiness:
[ ] Deployment runbook prepared
[ ] Post-deployment verification checklist prepared
[ ] Communication templates prepared (success / rollback)
Section 4: Deployment Steps
Document each step with precision:
Step | Time | Action | Responsible | Verification | Notes
-----|------|--------|-------------|--------------|------
1 | T+0:00 | Begin deployment window; confirm team readiness | Deploy Lead | Roll call complete |
2 | T+0:05 | Set system to maintenance mode | SysAdmin | Maintenance page displayed | Users see maintenance notice
3 | T+0:10 | Verify all active sessions closed | SysAdmin | Zero active sessions | Wait up to 5 min for sessions to close
4 | T+0:15 | Execute production database backup | DBA | Backup file verified, checksum recorded |
5 | T+0:25 | Execute database migration scripts | DBA | Scripts complete without error; row counts verified |
6 | T+0:35 | Deploy application release | Deploy Lead | Deployment tool shows success |
7 | T+0:40 | Update application configuration | SysAdmin | Config values verified |
8 | T+0:45 | Execute smoke tests | QA | All smoke tests pass | GO/NO-GO decision point
9 | T+0:50 | Execute post-deployment verification | QA | All verification checks pass |
10 | T+1:00 | Remove maintenance mode | SysAdmin | Application accessible |
11 | T+1:05 | Verify system accessible to users | QA | Login and basic navigation confirmed |
12 | T+1:10 | Send deployment complete notification | Deploy Lead | Notification sent |
13 | T+1:15 | Monitor system for 30 minutes | SysAdmin | No errors in logs |
14 | T+1:45 | Close deployment window | Deploy Lead | Deployment log completed |
For each step, also note:
- Estimated duration
- What constitutes success
- What constitutes failure and triggers rollback consideration
Section 5: Rollback Criteria and Procedure
Rollback Decision Criteria
Rollback is triggered if any of the following occur:
Automatic Rollback Triggers (no discussion needed):
- Data corruption detected
- Audit trail not functioning
- Electronic signatures not functioning
- System inaccessible after deployment
- Database migration failure
Judgment-Based Rollback Triggers (Deploy Lead + QA decision):
- Smoke test failures in non-critical areas
- Performance degradation beyond threshold
- Unexpected error patterns in logs
- Partial functionality loss
Rollback Authorization
Standard Release: Deploy Lead can authorize rollback
Critical Systems: Deploy Lead + QA + System Owner authorization required
(verbal authorization acceptable, documented within 24h)
Rollback Steps
Step | Action | Responsible | Verification
-----|--------|-------------|-------------
R1 | Announce rollback decision | Deploy Lead | Team acknowledged
R2 | Set system to maintenance mode | SysAdmin | Maintenance page displayed
R3 | Execute database rollback | DBA | Database restored; data verification
R4 | Restore application to previous version | Deploy Lead | Previous version deployed
R5 | Restore configuration to previous state | SysAdmin | Configuration verified
R6 | Execute smoke tests on restored system | QA | All smoke tests pass
R7 | Remove maintenance mode | SysAdmin | System accessible
R8 | Send rollback notification | Deploy Lead | Stakeholders notified
R9 | Document rollback in deployment log | Deploy Lead | Log complete
R10 | Schedule root cause analysis | QA | Meeting scheduled within 24h
Section 6: Post-Deployment Verification
Immediate Verification (within deployment window)
Core GxP Functions:
[ ] User login with correct credentials succeeds
[ ] User login with incorrect credentials fails
[ ] Role-based access controls enforce correctly
[ ] Audit trail records actions with correct metadata
[ ] Electronic signature captures all required fields
[ ] Data entry saves correctly
[ ] Edit checks fire as configured
[ ] Query workflow functions
[ ] Data export produces correct output
[ ] Reports generate correctly
System Health:
[ ] Application logs show no errors
[ ] Database connections stable
[ ] Response times within acceptable range
[ ] Background jobs/schedulers running
[ ] Integration endpoints responding
[ ] Monitoring tools showing healthy status
Extended Verification (24-48 hours post-deployment)
[ ] Overnight batch processes completed successfully
[ ] Automated backup completed successfully
[ ] No user-reported issues
[ ] Error log review (no new error patterns)
[ ] Performance metrics within normal range
[ ] Audit trail completeness check (sample review)
[ ] Integration data flow verification
Validation-Specific Verification
If the release required validation testing:
[ ] Validation test cases executed in production (if required by protocol)
[ ] Test results documented and reviewed
[ ] Deviations documented (if any)
[ ] Validation summary report updated
[ ] Traceability matrix updated
[ ] Validated state confirmed by QA
Section 7: Communication Plan
| When | What | To Whom | Method | Template |
|------|------|---------|--------|----------|
| Pre-deploy (48h) | Planned maintenance notice | All users, study teams | Email | COMM-001 |
| Pre-deploy (1h) | Deployment starting notice | Internal team | Chat/call | COMM-002 |
| Post-deploy (success) | Deployment complete, release notes | All users, study teams | Email | COMM-003 |
| Post-deploy (rollback) | Rollback notice | All users, study teams, management | Email + call | COMM-004 |
| Post-deploy (24h) | Extended verification results | Internal team | Email | COMM-005 |
Section 8: GxP Deployment Record
After deployment, complete the formal record:
Deployment Record:
Deployment Plan ID: DP-[ID]
Actual Start Time: [TIME]
Actual End Time: [TIME]
Outcome: Successful / Rolled Back / Partial
Steps Completed: [List or reference deployment log]
Deviations from Plan: [Document any deviations]
Post-Deployment Verification:
- Immediate verification: Pass / Fail
- Extended verification: Pass / Fail / Pending
Validation Status:
- Validated state maintained: Yes / No
- Validation documentation updated: Yes / No / N/A
- Traceability matrix updated: Yes / No / N/A
Signatures:
- Deployed by: [Name, Date]
- Verified by (QA): [Name, Date]
- Approved by (System Owner): [Name, Date]
Deployment Types
Standard Release
Full deployment plan with complete checklist. Minimum 5 business days lead time for preparation and approval.
Emergency Hotfix
Abbreviated deployment plan. Same structure but:
- Expedited approval (minimum 2 approvers: System Owner + QA)
- Reduced testing scope (focused on fix + regression of affected area)
- Full documentation completed within 5 business days post-deployment
- Post-implementation review required
Configuration-Only Change
Simplified deployment plan for non-code changes:
- Configuration change documented
- Before/after values recorded
- Verification that change is effective
- No application deployment required
Infrastructure Change
Deployment plan focused on:
- Infrastructure component identification
- Impact on hosted applications
- IQ re-execution if applicable
- Network and connectivity verification
- Performance baseline comparison
Metrics
Track deployment metrics:
- Deployment success rate (target: >95%)
- Rollback frequency (target: <5%)
- Mean deployment duration
- Post-deployment issues reported within 48h
- Time from change approval to production deployment
Regulatory References
- FDA 21 CFR Part 11 - System validation maintenance
- EU Annex 11 - Section 10: Change Management
- ISPE GAMP 5 - Operational Change and Configuration Management
- ICH E6(R2) - GCP (system maintenance and validation)
- ITIL Release and Deployment Management (adapted for GxP)
