Cross-cutting
Audit IQ
Compliance trail · every agent decision · every human action · inspector-replayable
Entries (last 100)
49
23 agent · 26 human
Agent decisions
47%
autonomous proportion
21 CFR Part 11
✓
immutable timestamps · e-sig ready
Retention
7 years
ICH E6(R3) compliant
Recent audit trail
Live from Postgres · audit_log + agent_decisions| Timestamp | Actor | Action | Entity | Reason / context | Meta |
|---|---|---|---|---|---|
| 5/27/2026, 16:18:41 | humanhuman | briefing_generated | briefing | Daily briefing per role | |
| 5/27/2026, 16:18:41 | agentportfolio-agent | agent_run | agent_decision | Daily briefing for Margaret Chen | opus-4-5-20251101 · portfolio |
| 5/27/2026, 16:17:55 | humanhuman | submission_agent_analysis | dossier | Live gap analysis with 9 FDA/ICH guidance citations | |
| 5/27/2026, 16:17:55 | humanhuman | briefing_invalidated | briefing | Cascade from Submission Agent — 1 critical gaps on BLA-HEM-021 | |
| 5/27/2026, 16:17:55 | agentsubmission-agent | agent_run | agent_decision | Dossier BLA-HEM-021 analysis | opus-4-5-20251101 · 26163ms · submission |
| 5/27/2026, 16:16:09 | humanhuman | csr_section_drafted | csr_section | Section 12.1 of CSL-HEM-021 CSR | |
| 5/27/2026, 16:16:09 | agentmedical-writer-agent | agent_run | agent_decision | Drafted 12.1 for CSL-HEM-021 | opus-4-5-20251101 · 10753ms · medical-writing |
| 5/27/2026, 16:14:45 | humanhuman | agent_investigation | alert | Risk Investigator on-demand fire | |
| 5/27/2026, 16:14:45 | agentrisk-investigator | agent_run | agent_decision | Alert enrollment_below_plan on CSL-HEM-021 | sonnet-4-5-20250929 · 21067ms · conduct |
| 5/27/2026, 16:14:45 | humanhuman | risk_cascade_detected | study | High-confidence root cause (72%) on enrollment_below_plan | |
| 5/27/2026, 16:14:45 | agentorchestrator | agent_run | agent_decision | Risk Investigator on CSL-HEM-021 alert enrollment_below_plan | rule-based · conduct |
| 5/27/2026, 16:12:06 | humanhuman | site_ranking_generated | study | Live ranking via PubMed + Open Payments | |
| 5/27/2026, 16:12:06 | agentsite-selection-agent | agent_run | agent_decision | Ranked sites for CSL-HEM-021 | sonnet-4-5-20250929 · 19223ms · patient-site |
| 5/27/2026, 16:01:10 | humanhuman | briefing_generated | briefing | Daily briefing per role | |
| 5/27/2026, 16:01:10 | agentportfolio-agent | agent_run | agent_decision | Daily briefing for Margaret Chen | opus-4-5-20251101 · portfolio |
| 5/27/2026, 16:01:09 | humanhuman | briefing_generated | briefing | Daily briefing per role | |
| 5/27/2026, 16:01:09 | agentportfolio-agent | agent_run | agent_decision | Daily briefing for Margaret Chen | opus-4-5-20251101 · portfolio |
| 5/27/2026, 15:49:42 | humanhuman | submission_agent_analysis | dossier | Live gap analysis with 1 FDA/ICH guidance citations | |
| 5/27/2026, 15:49:42 | humanhuman | briefing_invalidated | briefing | Cascade from Submission Agent — 0 critical gaps on MAA-IMM-203 | |
| 5/27/2026, 15:49:42 | agentsubmission-agent | agent_run | agent_decision | Dossier MAA-IMM-203 analysis | opus-4-5-20251101 · 22585ms · submission |
| 5/27/2026, 15:46:47 | humanhuman | briefing_generated | briefing | Daily briefing per role | |
| 5/27/2026, 15:46:47 | agentportfolio-agent | agent_run | agent_decision | Daily briefing for Aisha Patel | opus-4-5-20251101 · portfolio |
| 5/27/2026, 15:46:19 | humanhuman | briefing_generated | briefing | Daily briefing per role | |
| 5/27/2026, 15:46:19 | agentportfolio-agent | agent_run | agent_decision | Daily briefing for David Kowalski | opus-4-5-20251101 · portfolio |
| 5/27/2026, 15:46:03 | humanhuman | briefing_generated | briefing | Daily briefing per role | |
| 5/27/2026, 15:46:03 | agentportfolio-agent | agent_run | agent_decision | Daily briefing for Margaret Chen | opus-4-5-20251101 · portfolio |
| 5/27/2026, 15:44:54 | humanhuman | submission_agent_analysis | dossier | Live gap analysis with 9 FDA/ICH guidance citations | |
| 5/27/2026, 15:44:54 | humanhuman | briefing_invalidated | briefing | Cascade from Submission Agent — 1 critical gaps on BLA-HEM-021 | |
| 5/27/2026, 15:44:54 | agentsubmission-agent | agent_run | agent_decision | Dossier BLA-HEM-021 analysis | opus-4-5-20251101 · 28036ms · submission |
| 5/27/2026, 15:37:42 | humanhuman | agent_investigation | alert | Risk Investigator on-demand fire | |
| 5/27/2026, 15:37:42 | agentrisk-investigator | agent_run | agent_decision | Alert irb_stall on CSL-HAE-007 | sonnet-4-5-20250929 · 20363ms · conduct |
| 5/27/2026, 15:17:14 | humanhuman | site_ranking_generated | study | Live ranking via PubMed + Open Payments | |
| 5/27/2026, 15:17:14 | agentsite-selection-agent | agent_run | agent_decision | Ranked sites for CSL-HEM-021 | sonnet-4-5-20250929 · 15618ms · patient-site |
| 5/27/2026, 15:16:58 | humanhuman | regulatory_response_drafted | ha_query | Response to FDA Q-047 | |
| 5/27/2026, 15:16:58 | agentregulatory-agent | agent_run | agent_decision | HA response for Q-047 | opus-4-5-20251101 · 16018ms · regulatory |
| 5/27/2026, 15:16:42 | humanhuman | csr_section_drafted | csr_section | Section 12.1 of CSL-HEM-021 CSR | |
| 5/27/2026, 15:16:42 | agentmedical-writer-agent | agent_run | agent_decision | Drafted 12.1 for CSL-HEM-021 | opus-4-5-20251101 · 11358ms · medical-writing |
| 5/27/2026, 15:09:20 | humanhuman | submission_agent_analysis | dossier | Live gap analysis with 8 FDA/ICH guidance citations | |
| 5/27/2026, 15:09:20 | agentsubmission-agent | agent_run | agent_decision | Dossier BLA-HEM-021 analysis | opus-4-5-20251101 · 32505ms · submission |
| 5/27/2026, 14:59:02 | humanhuman | briefing_generated | briefing | Daily briefing per role | |
| 5/27/2026, 14:59:02 | agentportfolio-agent | agent_run | agent_decision | Daily briefing for Aakash Sharma | opus-4-5-20251101 · portfolio |
| 5/27/2026, 14:58:45 | humanhuman | briefing_generated | briefing | Daily briefing per role | |
| 5/27/2026, 14:58:45 | agentportfolio-agent | agent_run | agent_decision | Daily briefing for Karen Mitchell | opus-4-5-20251101 · portfolio |
| 5/27/2026, 14:58:30 | humanhuman | briefing_generated | briefing | Daily briefing per role | |
| 5/27/2026, 14:58:30 | agentportfolio-agent | agent_run | agent_decision | Daily briefing for David Kowalski | opus-4-5-20251101 · portfolio |
| 5/27/2026, 14:57:54 | humanhuman | agent_investigation | alert | Risk Investigator on-demand fire | |
| 5/27/2026, 14:57:54 | agentrisk-investigator | agent_run | agent_decision | Alert enrollment_below_plan on CSL-HEM-021 | sonnet-4-5-20250929 · 20291ms · conduct |
| 5/27/2026, 14:57:34 | humanhuman | briefing_generated | briefing | Daily briefing per role | |
| 5/27/2026, 14:57:34 | agentportfolio-agent | agent_run | agent_decision | Daily briefing for Margaret Chen | opus-4-5-20251101 · portfolio |
Every agent call writes to agent_decisions · every state change writes to audit_log · 21 CFR Part 11 compliant