release-monitoring

name	release-monitoring
description	Post-release monitoring plan for Talosix EDC deployments. Covers key metrics, alert thresholds, smoke test execution, and escalation procedures.
allowed-tools	Read, Grep, Glob, Bash

Release Monitoring Skill

Generate post-release monitoring plans and analyze monitoring data for Talosix EDC system releases. Clinical trial systems require heightened post-release observation to detect issues that could impact data integrity or patient safety.

When to Use

• Immediately after a production deployment
• When defining monitoring criteria for an upcoming release
• When analyzing post-release metrics to assess deployment health
• When investigating anomalies detected after a release

Monitoring Plan Structure

1. Monitoring Phases

Phase 1: Immediate (0-2 hours post-deploy)

• Active monitoring by deployment team
• Execute smoke tests
• Watch error rates, response times, system resources
• Go/no-go for rollback window closure

Phase 2: Short-term (2-24 hours post-deploy)

• Elevated monitoring with on-call awareness
• Monitor async processes (data exports, integrations, scheduled jobs)
• Watch for gradual degradation patterns

Phase 3: Extended (1-7 days post-deploy)

• Standard monitoring with release-specific alert rules
• Monitor user-reported issues for new patterns
• Watch clinical workflow completion rates

2. Key Metrics to Watch

System Health Metrics:

Metric	Normal Range	Warning	Critical
API response time (p50)	< 200ms	> 500ms	> 1000ms
API response time (p99)	< 1000ms	> 2000ms	> 5000ms
Error rate (5xx)	< 0.1%	> 0.5%	> 1%
Error rate (4xx)	< 2%	> 5%	> 10%
CPU utilization	< 60%	> 75%	> 90%
Memory utilization	< 70%	> 80%	> 95%
Database connection pool	< 70%	> 80%	> 95%
Disk I/O wait	< 10%	> 20%	> 40%

Clinical Workflow Metrics:

Metric	Normal Range	Warning	Critical
eCRF form save success rate	> 99.5%	< 99%	< 98%
Electronic signature success rate	> 99.9%	< 99.5%	< 99%
Audit trail write success rate	100%	< 100%	< 100%
Query workflow completion rate	> 99%	< 98%	< 95%
Data export success rate	> 99%	< 98%	< 95%
User login success rate	> 99%	< 98%	< 95%

Integration Metrics:

Metric	Normal Range	Warning	Critical
External API call success rate	> 99%	< 98%	< 95%
Message queue depth	< 1000	> 5000	> 10000
Integration sync latency	< 5 min	> 15 min	> 30 min

3. Smoke Test Execution

Execute the following smoke tests immediately after deployment:

Core Functionality:

1. User authentication (login, logout, session management)
2. eCRF form rendering for each form type modified in release
3. Data entry and save on a test subject
4. Edit check / validation rule firing
5. Electronic signature application
6. Audit trail generation and viewing
7. Query open, respond, close workflow
8. Role-based access control verification

Integration Points:

1. Lab data import processing
2. Randomization system connectivity (RTSM/IRT)
3. Coding dictionaries (MedDRA, WHODrug) availability
4. Data export generation (SAS, CSV)
5. Email notification delivery

Administrative Functions:

1. Study configuration access
2. User management operations
3. Report generation
4. System administration pages

4. Escalation Procedures

Severity Levels:

Level	Definition	Response Time	Escalation
SEV-1	System down or data integrity issue	Immediate	VP Engineering + CTO + Regulatory
SEV-2	Major feature broken, workaround unavailable	15 minutes	Engineering Manager + Product
SEV-3	Feature degraded, workaround available	1 hour	Engineering Lead
SEV-4	Minor issue, no workflow impact	Next business day	Sprint backlog

Escalation Path:

1. On-call engineer detects or is alerted to issue
2. Assess severity using criteria above
3. For SEV-1/SEV-2: Initiate incident response (see incident-response skill)
4. For SEV-1: Evaluate rollback per rollback plan
5. Notify stakeholders per severity communication matrix
6. Document all actions and decisions in incident channel

Clinical Impact Assessment: For any issue that may affect clinical data, additionally:

• Notify Clinical Operations lead immediately
• Assess whether affected studies need to pause data entry
• Determine if a field safety notice is required
• Evaluate 21 CFR Part 11 compliance impact

5. Monitoring Dashboard Checklist

Verify these dashboards are accessible and showing data:

• Application performance dashboard
• Error tracking dashboard (Sentry, Datadog, etc.)
• Database performance dashboard
• Infrastructure metrics dashboard
• Business metrics dashboard (form submissions, active users)
• Integration health dashboard
• Audit trail monitoring dashboard

6. Monitoring Completion Criteria

The release monitoring period ends when:

• All smoke tests passed
• No SEV-1 or SEV-2 issues in the monitoring period
• All metrics within normal ranges for 24+ hours
• No anomalous patterns in error logs
• Clinical workflow metrics stable
• Deployment team signs off on monitoring completion
• Monitoring completion documented in change control record

Using Allowed Tools

When analyzing post-release data:

• Use Read to examine log files and configuration
• Use Grep to search for error patterns in logs
• Use Glob to find relevant log and config files
• Use Bash to run monitoring queries or check system status

Output Format

Generate monitoring plans as structured markdown with clear metrics tables, runbook-style procedures, and checklists suitable for the on-call team.