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Build a clinical trial infrastructure dashboard
Monitor compute health, storage, and data pipelines across active studies
App
Monitor compute health, storage, and data pipelines across active studies
Draft a GxP validation impact assessment
Assess cloud migration impact with 21 CFR Part 11 compliance mapping
Document
Assess cloud migration impact with 21 CFR Part 11 compliance mapping
Build a Q3 architecture review deck
Pull data from Jira and ServiceNow into slides
Slide Deck
Pull data from Jira and ServiceNow into slides
Connect to our clinical trial compute platform and build a dashboard showing environment health, storage utilization, and data pipeline status across our active Phase II and Phase III studies.
AI
I'll need access to the clinical trial infrastructure API. Let me request that through a Gatekeeper.
🔒 Gatekeeper: Clinical Trial Infrastructure API
Requesting read-only access to compute health, storage metrics, and pipeline status. The Gatekeeper holds the credential and logs every query.
Requesting read-only access to compute health, storage metrics, and pipeline status. The Gatekeeper holds the credential and logs every query.
Approved.
AI
Access granted. Pulling infrastructure metrics now.
Executed code
const infra = await env.CTINFRA.getEnvironmentHealth({
phases: ["Phase-II", "Phase-III"],
include: ["compute", "storage", "pipelines"]
});
const alerts = infra.filter(
env => env.storagePct > 85 || env.pipelineStatus !== "healthy"
);
app.render(TrialInfraDashboard, { infra, alerts });
AI
Clinical Trial Infrastructure Dashboard is live. Connected via Gatekeeper -- read-only, every query logged.
I see 3 environments with capacity alerts. Want me to set up ServiceNow auto-tickets when storage exceeds 90%?
I see 3 environments with capacity alerts. Want me to set up ServiceNow auto-tickets when storage exceeds 90%?
+
Draft a validation impact assessment for migrating our LIMS and ELN environments to the new cloud infrastructure. Include 21 CFR Part 11 compliance mapping and GAMP 5 risk classification.
AI
I'll pull from your company's context library to ground this in AbbVie's validation standards.
📚 Context Library: GxP Standards
Loading AbbVie's current CSV procedures (v4.1), 21 CFR Part 11 compliance matrix, GAMP 5 framework guidelines, and cloud qualification standards. These are curated by your Quality team and read-only to the agent.
Loading AbbVie's current CSV procedures (v4.1), 21 CFR Part 11 compliance matrix, GAMP 5 framework guidelines, and cloud qualification standards. These are curated by your Quality team and read-only to the agent.
AI
Context loaded. I've identified 3 gaps in the current validation approach for cloud migration:
1. Electronic signature audit trail needs re-qualification for cloud-hosted LIMS
2. Data integrity controls require updating for multi-region object storage
3. Change control procedures need cloud-native CI/CD SDLC mapping
I'll address all three in the impact assessment.
1. Electronic signature audit trail needs re-qualification for cloud-hosted LIMS
2. Data integrity controls require updating for multi-region object storage
3. Change control procedures need cloud-native CI/CD SDLC mapping
I'll address all three in the impact assessment.
AI
GxP Validation Impact Assessment v1.0 draft is ready. Structured per GAMP 5 with AbbVie-specific procedures and 21 CFR Part 11 compliance mapping.
You can edit directly, export to Google Docs, or share for QA review. The document stays connected to the context library -- if validation standards change, I can flag sections that need updating.
You can edit directly, export to Google Docs, or share for QA review. The document stays connected to the context library -- if validation standards change, I can flag sections that need updating.
+
Build a Q3 architecture review deck summarizing our infrastructure modernization, cloud migration status, and upcoming initiatives. Pull data from Jira and ServiceNow.
AI
I'll need access to your project tracking and CMDB.
🔒 Gatekeeper: Jira (read-only)
Requesting access to the INFRA and PLATFORM projects. Read epics, status, and completion data only.
Requesting access to the INFRA and PLATFORM projects. Read epics, status, and completion data only.
🔒 Gatekeeper: ServiceNow CMDB (read-only)
Requesting access to the Configuration Management Database. Read CIs, relationships, and change records only.
Requesting access to the Configuration Management Database. Read CIs, relationships, and change records only.
Both approved.
AI
Executed code
const epics = await env.JIRA.getEpics({
projects: ["INFRA", "PLATFORM"],
quarter: "Q3-2026"
});
const cmdb = await env.SERVICENOW.getCIs({
category: "infrastructure",
changedSince: "2026-07-01"
});
deck.generate(QuarterlyReview, { epics, cmdb });
AI
Q3 Architecture Review deck is ready -- 4 slides from live Jira and ServiceNow data.
You can regenerate anytime to pick up changes, or edit individual slides. Export to Google Slides or PDF when ready to present.
You can regenerate anytime to pick up changes, or edit individual slides. Export to Google Slides or PDF when ready to present.
+
Gadget
Code
Connections
Clinical Trial Infrastructure Dashboard
99.94%
Platform Uptime
3
Capacity Alerts
847 TB
Data Processed Today
12ms
Avg Pipeline Latency
Capacity Alerts
⚠️ ABBV-951 Phase III (Parkinson's) -- Storage at 94%, exceeds 90% threshold. Expansion request auto-filed in ServiceNow.
⚠️ ILLUMINATE-3 (Lupus) -- GPU compute at 87%, approaching capacity limit for imaging analysis pipeline.
⚠️ RINVOQ RA Extension -- EDC data sync pipeline latency at 340ms, above 200ms SLA threshold.
Environment Health by Study
SKYRIZI Psoriasis Ph-IV
42%
Healthy
Emraclidine Ph-II (Schiz.)
58%
Healthy
Navitoclax Ph-III (MF)
67%
Healthy
EPKINLY DLBCL Ph-III
73%
Healthy
ILLUMINATE-3 (Lupus)
87%
Monitor
RINVOQ RA Extension
91%
High
ABBV-951 Phase III (PD)
94%
Critical
Page
Source
Connections
GxP Validation Impact Assessment v1.0
AbbVie -- GxP Validation Impact Assessment
1. Purpose
This assessment evaluates the validation impact of migrating AbbVie's Laboratory Information Management System (LIMS) and Electronic Lab Notebook (ELN) environments from on-premises infrastructure to the qualified cloud platform. It maps all 21 CFR Part 11 requirements to the target architecture and identifies re-qualification activities required to maintain GxP compliance.
2. Scope
- LIMS production and disaster recovery environments (R&D + QC)
- ELN platform including electronic signature workflows
- Data integrity controls for multi-region object storage [NEW]
- Integration points: CTMS, EDC, regulatory submission gateways
- Change control procedures for cloud-native CI/CD pipelines [NEW]
3. Risk Classification (GAMP 5)
| Category | System Component | Risk Level | Re-qualification |
|---|---|---|---|
| Cat. 5 | LIMS custom workflows & electronic signatures | High | Full IQ/OQ/PQ |
| Cat. 4 | ELN platform (configured COTS) | High | OQ/PQ + config audit |
| Cat. 3 | Cloud infrastructure (IaaS layer) | Medium | IQ + vendor audit |
| Cat. 1 | Operating systems & middleware | Low | Vendor documentation |
4. 21 CFR Part 11 Compliance Matrix
| Requirement | Current State | Cloud Target | Gap |
|---|---|---|---|
| 11.10(a) -- System validation | Validated on-prem | Re-qualify on cloud | Action required |
| 11.10(c) -- Authority checks | AD/LDAP integration | Azure AD SSO + MFA | Compliant |
| 11.10(e) -- Audit trail | Database-level logging | Immutable cloud audit log | Enhance |
| 11.50 -- Signature manifestation | On-prem e-sig module | Cloud e-sig with PKI | Action required |
| 11.300 -- Open system controls | N/A (closed network) | Encryption + access controls | New requirement |
FDA Guidance for Industry (2003, updated 2023): Computerized systems used in clinical investigations must maintain data integrity, audit trails, and electronic signature controls throughout the system lifecycle, including during platform migrations.
5. Escalation Matrix
| Role | Contact | Triggered At |
|---|---|---|
| Infrastructure Engineering Lead | infra-lead@abbvie.com | All migration activities |
| Quality Assurance Lead | qa-csv@abbvie.com | High-risk components |
| VP, Infrastructure | vp-infra@abbvie.com | Critical / schedule impact |
| Chief Information Officer | cio@abbvie.com | Regulatory risk only |
Slides
Source
Connections
Q3 Architecture Review
Integrations
Connect external services to AbbVie OS. Gatekeepers govern access, scope permissions, and log every action.
Gatekeepers
Google Workspace
Gmail, Docs, Sheets, Slides, Calendar, Drive
Microsoft Teams
Send messages, read channels, manage workflows
Jira
Projects, epics, issues, sprints, and boards
Confluence
Read and write wiki pages, search spaces
ServiceNow
IT tickets, change requests, CMDB, GxP change control
Workday
Employee data, org charts, payroll, time off, benefits
SAP
Finance, supply chain, procurement, and manufacturing ERP
Veeva Vault
Clinical data management, regulatory submissions, quality docs
GitHub
Access repositories, create PRs, manage issues
Snowflake
Data warehouse, analytics, cross-department reporting
Splunk / SIEM
Security events, alerts, monitoring, and compliance correlation
Power BI / Tableau
Dashboards, executive reporting, and data visualization
MCP Servers
Remote MCP servers available to all workspaces.
Clinical Trial Infrastructure API
https://ctinfra.mcp.abbvie.internal/mcp
Auto
LIMS / ELN Platform
https://lims.mcp.abbvie.internal/mcp
Needs auth
Manufacturing Execution System
https://mes.mcp.abbvie.internal/mcp
Needs auth
Employee Directory
https://directory.mcp.abbvie.internal/mcp
Auto
Cloudflare API
https://mcp.cloudflare.com/mcp
Auto
Context
Curated reference documents that ground your agent in AbbVie's knowledge. Published centrally, read-only to all agents and workspaces.
company-strategy-fy2027.md
AbbVie's strategic priorities, R&D pipeline milestones, digital transformation objectives, and key results by business unit
gxp-validation-standards.md
GxP validation policies, 21 CFR Part 11 requirements, CSV procedures, GAMP 5 risk frameworks, and cloud qualification standards
security-standards.md
Security policies, HIPAA requirements, SOX IT controls, data classification standards, and cryptographic requirements
architecture-principles.md
Enterprise architecture standards, cloud-first guidelines, decision criteria, review templates, and technology radar
vendor-requirements.md
Third-party vendor assessment criteria, TPRM scoring methodology, and pharmaceutical supply chain risk thresholds
infrastructure-inventory.md
System catalog: LIMS, ELN, CTMS, ERP, EDC with SLAs, ownership, dependency maps, and change advisory contacts
clinical-trial-systems.md
Clinical trial data management standards, EDC integration specs, CDISC requirements, and regulatory submission workflows
manufacturing-procedures.md
Manufacturing IT procedures, MES integration, batch record systems, serialization protocols, and site connectivity
hr-policies.md
Leave policies, performance review criteria, hiring procedures, and compensation guidelines
financial-reporting-standards.md
Chart of accounts, reporting cadence, audit requirements, and SOX compliance procedures
Skills
| Name | Description | Group | Source |
|---|---|---|---|
| meeting-prep | Scan calendar, gather context from connected systems, and generate briefing docs | General | AbbVie |
| weekly-report | Compile team activity summaries from Jira, ServiceNow, email, and calendar data | General | AbbVie |
| validation-assessment | Draft GxP validation impact assessments with 21 CFR Part 11 compliance mapping and GAMP 5 risk classification | Compliance | AbbVie |
| vendor-assessment | Generate vendor security and privacy questionnaires, compute risk scores against internal TPRM standards | Security | AbbVie |
| compliance-audit | Gather SOX, HIPAA, and GxP compliance evidence, map controls, and generate audit packages | Compliance | AbbVie |
| architecture-review | Build quarterly architecture review decks from Jira, ServiceNow, and Confluence data | Architecture | AbbVie |
| change-impact | Analyze change impact across GxP-validated systems, map dependencies, and identify affected teams | Architecture | AbbVie |
| api-catalog | Discover, document, and visualize internal API endpoints with ownership, health, and compliance status | Architecture | AbbVie |
| clinical-trial-ops | Monitor clinical trial infrastructure health, capacity planning, and data pipeline status across studies | Operations | AbbVie |
| cost-optimization | Cloud and infrastructure spend analysis, trend visualization, and optimization recommendations | Operations | AbbVie |
| incident-response | Draft or update incident response policies grounded in AbbVie security standards and NIST/HIPAA | Security | AbbVie |
| runbook-automation | Convert static runbooks into interactive step-by-step tools with automated pre-checks and GxP audit trails | Operations | AbbVie |
| budget-analysis | Pull spend data from SAP, compare to budget, flag variances, and forecast quarter-end | Finance | AbbVie |
| job-posting-draft | Draft job descriptions from role requirements, team context, and compensation guidelines | HR | AbbVie |
| onboarding-guide | Generate new hire documentation from wikis, org charts, and system access procedures | HR | AbbVie |
| regulatory-submission | Compile infrastructure qualification documents and data integrity evidence for regulatory submissions | Compliance | AbbVie |