Users and roles, taxonomy, metric definitions, integrations, audit trail, AI governance and compliance support.
Signed-in user
CURRENT_USER_ID; in a deployed tenant it comes from the SSO token and switching users means signing in as them.| User | Role | Function | Country / region | Products in scope | Active | Last login |
|---|---|---|---|---|---|---|
| HODr. Helen OkaforGlobal Head of Medical Affairs | Medical Affairs executive | Leadership | United States · North America | VantrexaNephradaLumevaAurelin | Active | 15 Sept 2026, 07:42 UTC |
| PRDr. Priya RamanGlobal Medical Lead, Vantrexa | Global medical lead | Leadership | United States · North America | Vantrexa | Active | 15 Sept 2026, 06:10 UTC |
| MLDr. Marcus LindqvistGlobal Medical Lead, Nephrada | Global medical lead | Leadership | Germany · Europe | Nephrada | Active | 14 Sept 2026, 16:55 UTC |
| EMDr. Elena MorettiGlobal Medical Lead, Lumeva | Global medical lead | Leadership | Italy · Europe | Lumeva | Active | 15 Sept 2026, 08:05 UTC |
| TFDr. Tomás FerreiraGlobal Medical Lead, Aurelin | Global medical lead | Leadership | United States · North America | Aurelin | Active | 12 Sept 2026, 13:20 UTC |
| SLDr. Sophie LaurentRegional Medical Lead, Europe | Regional medical lead | Leadership | France · Europe | VantrexaNephradaLumeva | Active | 15 Sept 2026, 07:00 UTC |
| KWDr. Kenji WatanabeCountry Medical Lead, Japan | Country medical lead | Leadership | Japan · Asia-Pacific | VantrexaLumeva | Active | 15 Sept 2026, 01:15 UTC |
| JWJames WhitfieldSenior MSL, Oncology (US East) | Field medical (MSL) | Field Medical | United States · North America | Vantrexa | Active | 15 Sept 2026, 11:30 UTC |
| ABDr. Anna BeckerMSL, Nephrology (DACH) | Field medical (MSL) | Field Medical | Germany · Europe | Nephrada | Active | 15 Sept 2026, 09:48 UTC |
| LOLuis OrtegaMSL, Neurology (Iberia) | Field medical (MSL) | Field Medical | Spain · Europe | Lumeva | Active | 14 Sept 2026, 17:22 UTC |
| MTMei TanakaMSL, Oncology (Japan) | Field medical (MSL) | Field Medical | Japan · Asia-Pacific | Vantrexa | Active | 15 Sept 2026, 02:05 UTC |
| RARachel AdeyemiMSL, Oncology (UK & Ireland) | Field medical (MSL) | Field Medical | United Kingdom · Europe | Vantrexa | Active | 15 Sept 2026, 08:40 UTC |
| DCDavid ChenHead of Medical Communications | Medical communications | Medical Communications | United States · North America | VantrexaNephradaLumevaAurelin | Active | 15 Sept 2026, 10:12 UTC |
| FAFatima Al-SayedMedical Information Lead | Medical information | Medical Information | United Kingdom · Europe | VantrexaNephradaLumevaAurelin | Active | 15 Sept 2026, 08:00 UTC |
| NPDr. Nikolai PetrovHead of Evidence Generation & HEOR | Evidence generation / HEOR | Evidence Generation | Germany · Europe | VantrexaNephradaLumevaAurelin | Active | 14 Sept 2026, 15:30 UTC |
| GNGrace NakamuraMedical Operations Lead | Medical operations | Medical Operations | United States · North America | VantrexaNephradaLumevaAurelin | Active | 15 Sept 2026, 12:01 UTC |
| OBOliver BrandtCompliance & Quality Partner | Compliance / audit | Compliance | Germany · Europe | VantrexaNephradaLumevaAurelin | Active | 13 Sept 2026, 09:10 UTC |
| SHSara HolmMarket Access Director | Cross-functional partner | Cross-functional | United States · North America | VantrexaNephrada | Active | 11 Sept 2026, 14:45 UTC |
| Capability | Executive | Medical Lead | Field Medical | Medical Ops | Compliance | Cross-functional |
|---|---|---|---|---|---|---|
| View portfolio dashboards | Yes | Yes | Limited | Yes | Yes | Limited |
| Create and edit medical plans | No | Yes | No | Configurable | No | No |
| Approve medical plans | Yes | Review | No | No | Review | No |
| Record engagements | No | Limited | Own records | No | No | No |
| View stakeholder profiles | Limited | Yes | Territory-based | Limited | Yes | Restricted |
| Capture insights | No | Yes | Own records | No | No | Limited |
| Review, prioritise and route insights | No | Yes | No | Configurable | Review | No |
| View restricted-class insights | Yes | Yes | No | No | Yes | No |
| Manage publications and congress activities | No | Yes | No | Configurable | Review | No |
| Handle medical-information inquiries | No | Limited | No | No | Review | No |
| Override launch readiness scores | No | Yes | No | No | Review | No |
| View budget and actuals | Yes | Yes | No | Limited | Limited | Restricted |
| Export data | Yes | Limited | Own records | Configurable | Yes | Restricted |
| Manage metric definitions | Review | Review | No | Yes | Review | No |
| Configure taxonomy and workflows | No | No | No | Yes | Review | No |
| Manage integrations | No | No | No | Yes | No | No |
| View audit trail | Limited | Limited | Own records | Limited | Yes | No |
| Approve AI feature enablement | Review | No | No | Yes | Review | No |
| Manage users and roles | No | No | No | Yes | Review | No |
Segregation of duties and configurability
| Role | Key | Description | Users |
|---|---|---|---|
| Platform administrator | platform_admin | Full tenant configuration. | 0 |
| Medical Affairs executive | ma_executive | Portfolio view, plan approval, exports. | 1 |
| Global medical lead | global_medical_lead | Owns product strategy and plans. | 4 |
| Regional medical lead | regional_medical_lead | Regional adaptation and oversight. | 1 |
| Country medical lead | country_medical_lead | Local plans and execution. | 1 |
| Field medical (MSL) | field_medical | Engagements and insight capture. | 5 |
| Medical communications | med_comms | Publications and congress deliverables. | 1 |
| Medical information | med_info | Inquiry handling and SLA monitoring. | 1 |
| Evidence generation / HEOR | evidence_gen | Research portfolio management. | 1 |
| Medical operations | med_ops | Workflows, metrics, integrations, data quality. | 1 |
| Compliance / audit | compliance | Audit trail, approvals, evidence packages. | 1 |
| Finance | finance | Budget and actuals. | 0 |
| Cross-functional partner | cross_functional | Scoped read access. | 1 |
| Read-only executive | read_only_exec | Dashboards only. | 0 |
| Brand | INN | Therapeutic area | Disease areas | Lifecycle stage | Global medical lead | Launch countries |
|---|---|---|---|---|---|---|
| Vantrexa VTX | vantrelimab | Oncology | Non-small cell lung cancer, Small cell lung cancer | Launch | PRDr. Priya Raman | 5 |
| Nephrada NPH | nephradin | Nephrology | IgA nephropathy, Focal segmental glomerulosclerosis | Pre-launch | MLDr. Marcus Lindqvist | 3 |
| Lumeva LMV | lumevarin | Neurology | Migraine | Mature post-launch | EMDr. Elena Moretti | 10 |
| Aurelin ARL | aurelinate | Immunology | Atopic dermatitis | Late clinical development | TFDr. Tomás Ferreira | 0 |
10 countries in the tenant list
10 default stages · order fixed · labels configurable per tenant
v3 · effective 2026-01-01 · local extensions controlled (regional admins may add sub-categories that roll up to these 22)
13 types
Configurable within controlled limits: labels and transitions may change; terminal states and audit semantics may not
Metric governance (PRD §21)
| ID | Name | Category | Module | Unit | Target | Refresh | Owner | Version | Approval | DQ |
|---|---|---|---|---|---|---|---|---|---|---|
| MET-001 | Strategic objective progress | Outcome | Planning | % | 70 | Daily | GNGrace Nakamura | v1 | Approved | Good |
| MET-002 | Initiatives linked to objectives | Quality | Planning | % | 90 | Daily | GNGrace Nakamura | v1 | Approved | Good |
| MET-003 | At-risk or blocked initiatives | Risk | Planning | count | — | Daily | GNGrace Nakamura | v1 | Approved | Good |
| MET-004 | Overdue actions | Risk | Work management | count | — | Daily | GNGrace Nakamura | v1 | Approved | Good |
| MET-010 | Completed engagements | Activity | Field medical | count | — | Daily | JWJames Whitfield | v1 | Approved | Good |
| MET-011 | Tier 1 stakeholder coverage | Output | Field medical | % | 85 | Daily | JWJames Whitfield | v1 | Approved | Good |
| MET-012 | Insight generation rate | Quality | Field medical | % | 35 | Daily | JWJames Whitfield | v1 | Approved | Good |
| MET-013 | Mean engagement quality | Quality | Field medical | score | 3.8 | Daily | JWJames Whitfield | v1 | Approved | Good |
| MET-014 | Follow-up completion | Quality | Field medical | % | 85 | Daily | JWJames Whitfield | v1 | Approved | Good |
| MET-020 | Insights captured | Activity | Insights | count | — | Daily | PRDr. Priya Raman | v1 | Approved | Good |
| MET-021 | High-priority insights | Leading | Insights | count | — | Daily | PRDr. Priya Raman | v1 | Approved | Good |
| MET-022 | Insight-to-action conversion | Outcome | Insights | % | 60 | Daily | PRDr. Priya Raman | v1 | Approved | Good |
| MET-023 | Median time to review | Quality | Insights | days | 3 | Daily | PRDr. Priya Raman | v1 | Approved | Good |
| MET-024 | Unresolved high-priority insights | Risk | Insights | count | — | Daily | PRDr. Priya Raman | v1 | Approved | Good |
| MET-025 | Duplicate rate | Data quality | Insights | % | — | Daily | GNGrace Nakamura | v1 | Approved | Good |
| MET-030 | Publication plan completion | Output | Publications | % | 90 | Daily | DCDavid Chen | v1 | Approved | Good |
| MET-031 | Acceptance rate | Outcome | Publications | % | — | Daily | DCDavid Chen | v1 | Approved | Good |
| MET-032 | Delayed publication milestones | Risk | Publications | count | — | Daily | DCDavid Chen | v1 | Approved | Good |
| MET-040 | Inquiry volume | Activity | Medical information | count | — | Daily | FAFatima Al-Sayed | v1 | Approved | Good |
| MET-041 | SLA compliance | Quality | Medical information | % | 92 | Daily | FAFatima Al-Sayed | v1 | Approved | Good |
| MET-042 | Median response time | Quality | Medical information | hours | 48 | Daily | FAFatima Al-Sayed | v1 | Approved | Good |
| MET-043 | Escalation rate | Risk | Medical information | % | — | Daily | FAFatima Al-Sayed | v1 | Approved | Good |
| MET-044 | Standard-response reuse | Quality | Medical information | % | 65 | Daily | FAFatima Al-Sayed | v1 | Approved | Good |
| MET-050 | Active evidence projects | Activity | Evidence generation | count | — | Daily | NPDr. Nikolai Petrov | v1 | Approved | Good |
| MET-051 | Approval cycle time | Quality | Evidence generation | days | 90 | Daily | NPDr. Nikolai Petrov | v1 | Approved | Good |
| MET-052 | Evidence gaps with an active project | Outcome | Evidence generation | % | 70 | Daily | NPDr. Nikolai Petrov | v1 | Approved | Good |
| MET-060 | Launch readiness score | Leading | Launch readiness | score | 85 | Daily | PRDr. Priya Raman | v1 | Approved | Good |
| MET-061 | At-risk launch milestones | Risk | Launch readiness | count | — | Daily | PRDr. Priya Raman | v1 | Approved | Good |
| MET-070 | Budget consumed | Activity | Budget | % | — | Monthly | GNGrace Nakamura | v1 | Approved | Good |
| MET-071 | Lines at overrun risk | Risk | Budget | count | — | Monthly | GNGrace Nakamura | v1 | Approved | Good |
| MET-080 | Open data-quality exceptions | Data quality | Data quality | count | — | Daily | GNGrace Nakamura | v1 | Approved | Good |
| MET-081 | Records lacking strategic linkage | Data quality | Data quality | count | — | Daily | GNGrace Nakamura | v1 | Approved | Good |
| MET-090 | Total KOL interactions (legacy) | Activity | Field medical | count | — | Daily | GNGrace Nakamura | v2 | Deprecated | Good |
| Integration | Direction | Schedule | Last sync | Records | Error queue | System of record | Owner | Status · actions |
|---|---|---|---|---|---|---|---|---|
| Veeva CRM — engagements & stakeholdersVeeva CRM · CRM · INT-01 | Inbound | Every 4 hours | 15 Sept 2026, 08:00 UTCtoday | 412 | 14 | Yes | GNGrace Nakamura | Degraded |
| Veeva Vault — approved contentVeeva Vault · Content · INT-02 | Inbound | Daily 02:00 UTC | 15 Sept 2026, 02:00 UTCtoday | 86 | 0 | Yes | DCDavid Chen | Healthy |
| Microsoft Entra ID — SSO & SCIMMicrosoft Entra ID · Identity · INT-03 | Inbound | Real-time | 15 Sept 2026, 11:58 UTCtoday | 18 | 0 | Yes | GNGrace Nakamura | Healthy |
| SAP — budget actualsSAP S/4HANA · Finance · INT-04 | Inbound | Monthly (3rd business day) | 03 Sept 2026, 02:00 UTC12 days ago | 1,240 | 0 | Yes | GNGrace Nakamura | Healthy |
| MI inquiry platformIRMS · Medical information · INT-05 | Inbound | Hourly | 15 Sept 2026, 11:00 UTCtoday | 27 | 0 | Yes | FAFatima Al-Sayed | Healthy |
| CTMS — study milestonesVeeva Vault CTMS · Study · INT-06 | Inbound | Daily 03:00 UTC | 13 Sept 2026, 03:00 UTC2 days ago | 0 | 3 | Yes | NPDr. Nikolai Petrov | Failed |
| ClinicalTrials.gov — competitor trialsClinicalTrials.gov API · External data · INT-07 | Inbound | Weekly | 12 Sept 2026, 06:00 UTC3 days ago | 212 | 0 | No | GNGrace Nakamura | Healthy |
| PubMed — publication metricsPubMed E-utilities · External data · INT-08 | Inbound | Weekly | 12 Sept 2026, 06:30 UTC3 days ago | 0 | 0 | No | DCDavid Chen | Paused |
Every connector must provide these before it is enabled in production.
| Entity | System of record | Note |
|---|---|---|
| Stakeholders | Veeva CRM | Hub holds a governed copy; edits flow back through the CRM |
| Engagements | Veeva CRM | Captured in CRM or Hub mobile capture; CRM is authoritative |
| Approved content | Veeva Vault | Approval status and version read-only in Hub |
| Budget actuals | SAP S/4HANA | Monthly extract; Hub plans and forecasts locally |
| Inquiries | IRMS | Hub reads status, SLA and categorisation |
| Study milestones | Veeva Vault CTMS | Evidence projects reference CTMS milestone ids |
| Plans, objectives, insights, launch scorecards | Hub | Hub is the system of record |
Append-only and tamper-evident: each event is chained to the previous one by hash; nothing is edited or deleted, corrections are new events.
/api/audit?format=csvElectronic signature events in view
| Timestamp (UTC) | Record | Action | User | Field | Change | Reason | Source | Session · chain |
|---|---|---|---|---|---|---|---|---|
| 15 Sept 2026, 07:42 UTC | Session · u-helen | Login | HODr. Helen OkaforMedical Affairs executive | — | SSO (Entra ID) · MFA satisfied | — | UI | AUD-001815 sess-1b2c · 10.12.4.22 · #8fd3… |
| 15 Sept 2026, 02:00 UTC | Stakeholder · STK-0007 | Update | GNGrace NakamuraMedical operations | dataQuality | Good → Duplicate suspected | — | Integration | AUD-001811 svc-veeva-sync · #8bd3… |
| 14 Sept 2026, 18:43 UTC | Initiative · INI-0068 | Update | JWJames WhitfieldField medical (MSL) | dueDate | Draft → Submitted | — | UI | AUD-002099 sess-70a4 · 10.12.5.109 · #491e… |
| 14 Sept 2026, 18:12 UTC | Publication · PUB-0091 | Update | JWJames WhitfieldField medical (MSL) | summary | Draft → Reviewed | — | Integration | AUD-002134 sess-5702 · 10.12.3.245 · #b5df… |
| 14 Sept 2026, 14:09 UTC | Initiative · INI-0117 | Update | MTMei TanakaField medical (MSL) | status | — → Reviewed | — | UI | AUD-002033 sess-f6ad · 10.12.1.110 · #c305… |
| 14 Sept 2026, 13:27 UTC | Initiative · INI-0071 | Create | ABDr. Anna BeckerField medical (MSL) | dueDate | Draft → Completed | — | Integration | AUD-002102 sess-c75e · 10.12.16.158 · #49dc… |
| 14 Sept 2026, 13:23 UTC | Engagement · ENG-0023 | Create | LOLuis OrtegaField medical (MSL) | topics | — → In progress | — | UI | AUD-002151 sess-a4b2 · 10.12.18.211 · #aed0… |
| 14 Sept 2026, 12:57 UTC | Initiative · INI-0099 | Update | JWJames WhitfieldField medical (MSL) | dueDate | — → In progress | — | UI | AUD-002144 sess-f958 · 10.12.17.85 · #b7d2… |
| 14 Sept 2026, 09:27 UTC | Task · T-0054 | Create | PRDr. Priya RamanGlobal medical lead | notes | — → In progress | — | UI | AUD-002157 sess-6abc · 10.12.16.15 · #b4d0… |
| 14 Sept 2026, 08:47 UTC | Insight · INS-0065 | Update | RARachel AdeyemiField medical (MSL) | status | In progress → Reviewed | — | UI | AUD-002063 sess-a899 · 10.12.10.229 · #5b0d… |
| 14 Sept 2026, 08:14 UTC | Inquiry · MI-2026-0812 | Update | FAFatima Al-SayedMedical information | status | Triage → Escalated | Safety flag; PV notified | UI | AUD-001802 sess-0a11 · 10.13.7.60 · #8ed5… |
| 14 Sept 2026, 07:15 UTC | Insight · INS-0012 | Create | MTMei TanakaField medical (MSL) | progress | In progress → Submitted | — | Integration | AUD-002002 sess-44b8 · 10.12.11.99 · #ca08… |
| 14 Sept 2026, 06:05 UTC | Initiative · INI-0015 | Update | GNGrace NakamuraMedical operations | dueDate | Planned → In progress | — | Integration | AUD-002043 sess-c4f1 · 10.12.5.5 · #4311… |
| 13 Sept 2026, 16:31 UTC | Inquiry · MI-2026-0013 | Create | FAFatima Al-SayedMedical information | topics | Draft → Submitted | — | API | AUD-002012 sess-8911 · 10.12.1.218 · #d40a… |
| 13 Sept 2026, 14:08 UTC | Publication · PUB-0018 | Update | JWJames WhitfieldField medical (MSL) | dueDate | Draft → Submitted | — | UI | AUD-002111 sess-a416 · 10.12.9.24 · #46da… |
| 13 Sept 2026, 13:16 UTC | Engagement · ENG-0073 | Update | MTMei TanakaField medical (MSL) | progress | — → Submitted | — | API | AUD-002042 sess-e1ba · 10.12.7.83 · #4211… |
| 13 Sept 2026, 09:45 UTC | Audit trail · MP-2026-VTX-G | Export | OBOliver BrandtCompliance / audit | — | Evidence package (PDF+CSV), 214 events | Q3 internal audit | UI | AUD-001788 sess-f3d8 · 10.13.7.5 · #9f85… |
| 13 Sept 2026, 08:26 UTC | Insight · INS-0071 | Update | DCDavid ChenMedical communications | dueDate | In progress → Completed | — | UI | AUD-002137 sess-b663 · 10.12.14.131 · #b4df… |
| 13 Sept 2026, 07:38 UTC | Task · T-0019 | Update | MTMei TanakaField medical (MSL) | status | Draft → Submitted | — | UI | AUD-002046 sess-885b · 10.12.20.224 · #4611… |
| 12 Sept 2026, 18:07 UTC | Task · T-0115 | Update | PRDr. Priya RamanGlobal medical lead | notes | In progress → In progress | — | UI | AUD-002078 sess-e40a · 10.12.20.208 · #560f… |
| 12 Sept 2026, 15:39 UTC | Initiative · INI-0034 | Update | LOLuis OrtegaField medical (MSL) | topics | In progress → Submitted | — | Integration | AUD-002092 sess-3dcf · 10.12.20.170 · #441e… |
| 12 Sept 2026, 14:01 UTC | Task · T-0036 | Update | LOLuis OrtegaField medical (MSL) | topics | — → Reviewed | — | UI | AUD-002131 sess-1f4 · 10.12.16.155 · #b2df… |
| 12 Sept 2026, 13:57 UTC | Engagement · ENG-0017 | Update | PRDr. Priya RamanGlobal medical lead | dueDate | Planned → In progress | — | UI | AUD-002154 sess-5e6e · 10.12.7.218 · #b1d0… |
| 12 Sept 2026, 13:15 UTC | Task · T-0072 | Close | DCDavid ChenMedical communications | summary | Planned → Reviewed | — | UI | AUD-002146 sess-6104 · 10.12.3.68 · #b5d2… |
| 12 Sept 2026, 12:52 UTC | Insight · INS-0069 | Update | RARachel AdeyemiField medical (MSL) | notes | In progress → Submitted | — | UI | AUD-002124 sess-cb1b · 10.12.5.120 · #b3e1… |
| 12 Sept 2026, 12:52 UTC | Publication · PUB-0114 | Update | JWJames WhitfieldField medical (MSL) | notes | Planned → In progress | — | Integration | AUD-002087 sess-6308 · 10.12.6.172 · #d71b… |
| 12 Sept 2026, 12:41 UTC | Insight · INS-0033 | Update | LOLuis OrtegaField medical (MSL) | summary | Draft → Completed | — | UI | AUD-002023 sess-d408 · 10.12.18.53 · #c303… |
| 12 Sept 2026, 12:05 UTC | Initiative · INI-0065 | Create | PRDr. Priya RamanGlobal medical lead | dueDate | Draft → In progress | — | UI | AUD-002121 sess-5a9f · 10.12.4.26 · #b6e1… |
| 12 Sept 2026, 11:45 UTC | Task · T-0019 | Update | FAFatima Al-SayedMedical information | summary | In progress → Submitted | — | UI | AUD-002117 sess-7c6 · 10.12.20.55 · #44da… |
| 12 Sept 2026, 11:23 UTC | Inquiry · MI-2026-0101 | Close | MTMei TanakaField medical (MSL) | progress | Planned → Completed | — | API | AUD-002080 sess-f4e6 · 10.12.20.73 · #dc1b… |
| 12 Sept 2026, 10:54 UTC | Task · T-0067 | Create | LOLuis OrtegaField medical (MSL) | progress | Draft → Completed | — | UI | AUD-002038 sess-ee0 · 10.12.12.28 · #ce05… |
| 12 Sept 2026, 09:10 UTC | Insight · INS-0047 | Update | PRDr. Priya RamanGlobal medical lead | ai.suggestedPriority | High → Critical | Breadth: ≥ 3 centres; brain-metastasis gap is a plan evidence gap | UI | AUD-001733 sess-d4b2 · 10.12.9.8 · #2aa0… |
| 12 Sept 2026, 08:52 UTC | Initiative · INI-0008 | Update | MTMei TanakaField medical (MSL) | notes | — → In progress | — | UI | AUD-002077 sess-9217 · 10.12.2.123 · #570f… |
| 12 Sept 2026, 06:22 UTC | Engagement · ENG-0054 | Create | RARachel AdeyemiField medical (MSL) | topics | — → In progress | — | UI | AUD-002031 sess-ffb2 · 10.12.15.138 · #c505… |
| 11 Sept 2026, 18:09 UTC | Publication · PUB-0026 | Create | MTMei TanakaField medical (MSL) | progress | In progress → Submitted | — | API | AUD-002062 sess-fa22 · 10.12.19.68 · #5a0d… |
| 11 Sept 2026, 17:21 UTC | Task · T-0064 | Create | MTMei TanakaField medical (MSL) | notes | Planned → In progress | — | UI | AUD-002126 sess-1946 · 10.12.12.226 · #b5e1… |
| 11 Sept 2026, 15:40 UTC | Publication · PUB-0022 | Create | LOLuis OrtegaField medical (MSL) | notes | — → Submitted | — | API | AUD-002150 sess-203d · 10.12.19.73 · #add0… |
| 11 Sept 2026, 14:42 UTC | Initiative · INI-0071 | Update | ABDr. Anna BeckerField medical (MSL) | status | — → Submitted | — | Integration | AUD-002113 sess-7372 · 10.12.10.136 · #48da… |
| 11 Sept 2026, 14:40 UTC | Task · T-0031 | Update | MTMei TanakaField medical (MSL) | topics | Draft → Reviewed | — | UI | AUD-002006 sess-1674 · 10.12.7.226 · #c608… |
| 11 Sept 2026, 14:37 UTC | Inquiry · MI-2026-0037 | Close | JWJames WhitfieldField medical (MSL) | topics | Draft → Submitted | — | UI | AUD-002093 sess-4d9d · 10.12.10.88 · #431e… |
| 11 Sept 2026, 14:21 UTC | Insight · INS-0022 | Close | JWJames WhitfieldField medical (MSL) | topics | In progress → In progress | — | API | AUD-002158 sess-23a4 · 10.12.13.192 · #b5d0… |
| 11 Sept 2026, 13:05 UTC | Insight · INS-0058 | Route | MLDr. Marcus LindqvistGlobal medical lead | routedTo | — → Safety | Potential adverse event — PV handoff per SOP-PV-014 | UI | AUD-001760 sess-e0c7 · 10.13.2.41 · #2b93… |
| 11 Sept 2026, 13:02 UTC | Engagement · ENG-0083 | Close | DCDavid ChenMedical communications | summary | In progress → In progress | — | Integration | AUD-002156 sess-2fff · 10.12.16.196 · #b3d0… |
| 11 Sept 2026, 12:43 UTC | Insight · INS-0025 | Close | FAFatima Al-SayedMedical information | summary | — → Submitted | — | UI | AUD-002013 sess-57f7 · 10.12.4.166 · #d30a… |
| 11 Sept 2026, 12:06 UTC | Engagement · ENG-0037 | Close | GNGrace NakamuraMedical operations | dueDate | Planned → Reviewed | — | Integration | AUD-002073 sess-1e95 · 10.12.6.118 · #5b0f… |
| 11 Sept 2026, 11:00 UTC | Initiative · INI-0070 | Create | PRDr. Priya RamanGlobal medical lead | status | — → Completed | — | UI | AUD-002056 sess-4561 · 10.12.9.142 · #c814… |
| 11 Sept 2026, 10:14 UTC | Engagement · ENG-0025 | Update | DCDavid ChenMedical communications | topics | Planned → Completed | — | UI | AUD-002138 sess-6ec · 10.12.20.210 · #b9df… |
| 11 Sept 2026, 08:25 UTC | Publication · PUB-0007 | Create | FAFatima Al-SayedMedical information | status | — → Reviewed | — | UI | AUD-002039 sess-d85d · 10.12.5.122 · #cd05… |
| 11 Sept 2026, 07:45 UTC | Initiative · INI-0040 | Update | GNGrace NakamuraMedical operations | dueDate | Planned → Reviewed | — | UI | AUD-002021 sess-d450 · 10.12.6.227 · #c103… |
| 10 Sept 2026, 18:47 UTC | Initiative · INI-0092 | Update | FAFatima Al-SayedMedical information | dueDate | In progress → Reviewed | — | Integration | AUD-002142 sess-5924 · 10.12.2.167 · #b1d2… |
| 10 Sept 2026, 16:03 UTC | Initiative · INI-0095 | Update | ABDr. Anna BeckerField medical (MSL) | status | In progress → Reviewed | — | Integration | AUD-002130 sess-5856 · 10.12.14.124 · #b1df… |
| 10 Sept 2026, 15:42 UTC | Insight · INS-0047 | Update | JWJames WhitfieldField medical (MSL) | ai.summary | AI summary generated (helixor-private-llm-2026.08, confidence 0.86) | — | AI | AUD-001702 svc-ai-orchestrator · #9999… |
| 10 Sept 2026, 15:42 UTC | Insight · INS-0047 | Create | JWJames WhitfieldField medical (MSL) | — | Captured from ENG-0007 | — | UI | AUD-001701 sess-c1a9 · mobile · #9898… |
| 10 Sept 2026, 15:14 UTC | Inquiry · MI-2026-0061 | Create | MTMei TanakaField medical (MSL) | topics | Draft → In progress | — | UI | AUD-002009 sess-afa · 10.12.10.107 · #d508… |
| 10 Sept 2026, 14:47 UTC | Engagement · ENG-0110 | Update | MTMei TanakaField medical (MSL) | summary | In progress → Submitted | — | API | AUD-002028 sess-5854 · 10.12.5.113 · #c803… |
| 10 Sept 2026, 12:04 UTC | Initiative · INI-0028 | Update | GNGrace NakamuraMedical operations | progress | Draft → In progress | — | UI | AUD-002128 sess-af0 · 10.12.8.87 · #bfe1… |
| 10 Sept 2026, 11:43 UTC | Engagement · ENG-0030 | Update | GNGrace NakamuraMedical operations | status | Draft → Completed | — | UI | AUD-002107 sess-14c4 · 10.12.7.22 · #44dc… |
| 10 Sept 2026, 06:11 UTC | Publication · PUB-0036 | Update | FAFatima Al-SayedMedical information | notes | Draft → Completed | — | Integration | AUD-002034 sess-78e4 · 10.12.4.204 · #ca05… |
| 09 Sept 2026, 18:49 UTC | Task · T-0101 | Update | ABDr. Anna BeckerField medical (MSL) | status | Planned → In progress | — | UI | AUD-002030 sess-5669 · 10.12.1.19 · #c605… |
| 09 Sept 2026, 17:54 UTC | Publication · PUB-0029 | Update | JWJames WhitfieldField medical (MSL) | progress | Planned → Reviewed | — | UI | AUD-002095 sess-84a9 · 10.12.2.157 · #451e… |
| 09 Sept 2026, 15:59 UTC | Task · T-0009 | Close | GNGrace NakamuraMedical operations | notes | — → Reviewed | — | UI | AUD-002060 sess-bad5 · 10.12.2.167 · #580d… |
| 09 Sept 2026, 15:16 UTC | Insight · INS-0041 | Close | ABDr. Anna BeckerField medical (MSL) | progress | In progress → In progress | — | Integration | AUD-002064 sess-6d38 · 10.12.4.48 · #540d… |
| 09 Sept 2026, 14:48 UTC | Publication · PUB-0077 | Update | RARachel AdeyemiField medical (MSL) | summary | Draft → Reviewed | — | API | AUD-002081 sess-89ac · 10.12.19.19 · #dd1b… |
| 09 Sept 2026, 11:02 UTC | Initiative · INI-0102 | Update | MTMei TanakaField medical (MSL) | topics | In progress → Reviewed | — | UI | AUD-002075 sess-3e0c · 10.12.4.22 · #590f… |
| 09 Sept 2026, 10:41 UTC | Publication · PUB-0092 | Update | MTMei TanakaField medical (MSL) | progress | Draft → Submitted | — | UI | AUD-002089 sess-c28d · 10.12.9.113 · #d51b… |
| 09 Sept 2026, 09:27 UTC | Insight · INS-0027 | Update | FAFatima Al-SayedMedical information | dueDate | In progress → In progress | — | UI | AUD-002044 sess-a4f6 · 10.12.18.104 · #4811… |
| 09 Sept 2026, 07:43 UTC | Publication · PUB-0003 | Close | FAFatima Al-SayedMedical information | summary | Planned → Completed | — | UI | AUD-002119 sess-ecd6 · 10.12.14.174 · #3eda… |
| 09 Sept 2026, 07:23 UTC | Initiative · INI-0010 | Update | ABDr. Anna BeckerField medical (MSL) | summary | Draft → Submitted | — | Integration | AUD-002017 sess-52a0 · 10.12.5.239 · #d70a… |
| 08 Sept 2026, 18:01 UTC | Inquiry · MI-2026-0052 | Create | JWJames WhitfieldField medical (MSL) | topics | — → Completed | — | Integration | AUD-002098 sess-787 · 10.12.2.249 · #4a1e… |
| 08 Sept 2026, 15:30 UTC | Medical plan · MP-2026-ARL-G | Update | TFDr. Tomás FerreiraGlobal medical lead | version | 1 → 2 | Revised after Clinical Development comments | UI | AUD-001655 sess-b7f1 · 10.12.4.90 · #9661… |
| 08 Sept 2026, 15:23 UTC | Insight · INS-0071 | Create | GNGrace NakamuraMedical operations | notes | — → Completed | — | Integration | AUD-002069 sess-65a3 · 10.12.5.16 · #510d… |
| 08 Sept 2026, 13:36 UTC | Task · T-0101 | Update | JWJames WhitfieldField medical (MSL) | notes | — → In progress | — | UI | AUD-002074 sess-cdbc · 10.12.10.47 · #5a0f… |
| 08 Sept 2026, 09:57 UTC | Engagement · ENG-0056 | Update | ABDr. Anna BeckerField medical (MSL) | status | — → Submitted | — | Integration | AUD-002153 sess-c58 · 10.12.7.173 · #b0d0… |
| 08 Sept 2026, 09:23 UTC | Inquiry · MI-2026-0102 | Update | LOLuis OrtegaField medical (MSL) | summary | Planned → Completed | — | API | AUD-002159 sess-1cdf · 10.12.1.109 · #b6d0… |
| 08 Sept 2026, 07:05 UTC | Engagement · ENG-0112 | Update | FAFatima Al-SayedMedical information | notes | — → Reviewed | — | UI | AUD-002014 sess-3dec · 10.12.19.232 · #d60a… |
| 07 Sept 2026, 18:39 UTC | Insight · INS-0080 | Update | ABDr. Anna BeckerField medical (MSL) | summary | In progress → Reviewed | — | Integration | AUD-002147 sess-425b · 10.12.17.84 · #b4d2… |
| 07 Sept 2026, 18:29 UTC | Engagement · ENG-0004 | Update | GNGrace NakamuraMedical operations | notes | Planned → Reviewed | — | UI | AUD-002037 sess-c82b · 10.12.13.196 · #c705… |
| 07 Sept 2026, 15:48 UTC | Publication · PUB-0093 | Update | ABDr. Anna BeckerField medical (MSL) | dueDate | Draft → Reviewed | — | API | AUD-002090 sess-e6e9 · 10.12.6.139 · #421e… |
| 07 Sept 2026, 12:50 UTC | Insight · INS-0101 | Update | DCDavid ChenMedical communications | summary | — → Reviewed | — | API | AUD-002114 sess-957a · 10.12.7.4 · #41da… |
| 07 Sept 2026, 12:37 UTC | Insight · INS-0006 | Update | FAFatima Al-SayedMedical information | topics | — → In progress | — | UI | AUD-002070 sess-40ab · 10.12.9.148 · #5e0f… |
| 07 Sept 2026, 11:54 UTC | Engagement · ENG-0014 | Update | DCDavid ChenMedical communications | progress | Planned → In progress | — | Integration | AUD-002084 sess-3d15 · 10.12.20.79 · #d81b… |
| 07 Sept 2026, 11:13 UTC | Insight · INS-0093 | Update | FAFatima Al-SayedMedical information | summary | In progress → In progress | — | API | AUD-002100 sess-227 · 10.12.15.144 · #4bdc… |
| 07 Sept 2026, 08:53 UTC | Publication · PUB-0039 | Close | LOLuis OrtegaField medical (MSL) | dueDate | — → In progress | — | UI | AUD-002003 sess-a70 · 10.12.1.58 · #cb08… |
| 07 Sept 2026, 08:37 UTC | Inquiry · MI-2026-0081 | Update | LOLuis OrtegaField medical (MSL) | status | Draft → In progress | — | UI | AUD-002041 sess-2256 · 10.12.5.1 · #4511… |
| 07 Sept 2026, 07:54 UTC | Insight · INS-0026 | Close | FAFatima Al-SayedMedical information | summary | — → In progress | — | UI | AUD-002067 sess-c833 · 10.12.1.185 · #570d… |
| 07 Sept 2026, 06:58 UTC | Initiative · INI-0102 | Update | GNGrace NakamuraMedical operations | summary | Planned → Reviewed | — | Integration | AUD-002143 sess-83f0 · 10.12.17.119 · #b0d2… |
| 06 Sept 2026, 18:29 UTC | Task · T-0110 | Update | GNGrace NakamuraMedical operations | notes | Draft → Submitted | — | UI | AUD-002105 sess-2fcf · 10.12.11.232 · #46dc… |
| 06 Sept 2026, 17:36 UTC | Insight · INS-0050 | Close | JWJames WhitfieldField medical (MSL) | notes | Draft → Submitted | — | API | AUD-002112 sess-a776 · 10.12.3.80 · #47da… |
| 06 Sept 2026, 17:03 UTC | Publication · PUB-0061 | Close | GNGrace NakamuraMedical operations | summary | Planned → Submitted | — | Integration | AUD-002018 sess-dacc · 10.12.6.106 · #ca0a… |
| 06 Sept 2026, 16:11 UTC | Task · T-0094 | Create | GNGrace NakamuraMedical operations | notes | Planned → Completed | — | API | AUD-002152 sess-6b39 · 10.12.5.249 · #afd0… |
| 06 Sept 2026, 16:04 UTC | Publication · PUB-0049 | Create | PRDr. Priya RamanGlobal medical lead | dueDate | Draft → Submitted | — | UI | AUD-002036 sess-ed98 · 10.12.16.39 · #c805… |
| 06 Sept 2026, 16:02 UTC | Publication · PUB-0100 | Update | FAFatima Al-SayedMedical information | progress | — → Completed | — | Integration | AUD-002122 sess-e28d · 10.12.1.60 · #b9e1… |
| 06 Sept 2026, 15:26 UTC | Publication · PUB-0035 | Update | GNGrace NakamuraMedical operations | status | In progress → Completed | — | Integration | AUD-002110 sess-ca2 · 10.12.15.249 · #45da… |
| 06 Sept 2026, 15:19 UTC | Initiative · INI-0067 | Create | MTMei TanakaField medical (MSL) | summary | Draft → Completed | — | UI | AUD-002051 sess-cf8f · 10.12.8.105 · #c914… |
| 06 Sept 2026, 13:41 UTC | Inquiry · MI-2026-0044 | Update | MTMei TanakaField medical (MSL) | summary | Planned → Completed | — | UI | AUD-002140 sess-34a7 · 10.12.12.63 · #b3d2… |
| 06 Sept 2026, 11:33 UTC | Insight · INS-0075 | Update | GNGrace NakamuraMedical operations | status | — → Reviewed | — | UI | AUD-002083 sess-e4eb · 10.12.16.206 · #db1b… |
| 06 Sept 2026, 10:00 UTC | Insight · INS-0102 | Update | PRDr. Priya RamanGlobal medical lead | topics | Draft → Submitted | — | Integration | AUD-002115 sess-293d · 10.12.1.113 · #42da… |
| 06 Sept 2026, 09:52 UTC | Publication · PUB-0023 | Update | JWJames WhitfieldField medical (MSL) | status | Draft → In progress | — | API | AUD-002035 sess-58ae · 10.12.2.209 · #c905… |
| 06 Sept 2026, 08:29 UTC | Task · T-0108 | Close | JWJames WhitfieldField medical (MSL) | notes | In progress → Submitted | — | UI | AUD-002019 sess-1e1d · 10.12.9.195 · #c90a… |
| 06 Sept 2026, 07:49 UTC | Inquiry · MI-2026-0056 | Close | MTMei TanakaField medical (MSL) | notes | — → Submitted | — | Integration | AUD-002072 sess-e325 · 10.12.5.221 · #5c0f… |
| 06 Sept 2026, 06:37 UTC | Inquiry · MI-2026-0040 | Update | LOLuis OrtegaField medical (MSL) | status | — → Completed | — | Integration | AUD-002015 sess-9220 · 10.12.10.124 · #d50a… |
| 06 Sept 2026, 06:00 UTC | Task · T-0048 | Create | GNGrace NakamuraMedical operations | progress | In progress → Completed | — | UI | AUD-002103 sess-3fae · 10.12.3.201 · #48dc… |
| 05 Sept 2026, 18:51 UTC | Inquiry · MI-2026-0065 | Create | DCDavid ChenMedical communications | summary | Draft → In progress | — | UI | AUD-002048 sess-b35b · 10.12.16.50 · #4c11… |
| 05 Sept 2026, 17:40 UTC | Publication · PUB-0046 | Update | PRDr. Priya RamanGlobal medical lead | dueDate | Draft → Submitted | — | UI | AUD-002053 sess-c82c · 10.12.13.84 · #cb14… |
| 05 Sept 2026, 14:08 UTC | Task · T-0100 | Update | ABDr. Anna BeckerField medical (MSL) | status | In progress → In progress | — | UI | AUD-002066 sess-188b · 10.12.20.29 · #560d… |
| 05 Sept 2026, 13:39 UTC | Initiative · INI-0069 | Close | DCDavid ChenMedical communications | summary | Planned → Completed | — | Integration | AUD-002145 sess-da61 · 10.12.18.50 · #b6d2… |
| 05 Sept 2026, 13:37 UTC | Insight · INS-0046 | Close | FAFatima Al-SayedMedical information | dueDate | Draft → Completed | — | UI | AUD-002040 sess-63b7 · 10.12.4.162 · #4411… |
| 05 Sept 2026, 13:04 UTC | Engagement · ENG-0029 | Update | LOLuis OrtegaField medical (MSL) | summary | In progress → In progress | — | UI | AUD-002055 sess-76c4 · 10.12.6.103 · #c514… |
| 05 Sept 2026, 10:17 UTC | Publication · PUB-0004 | Close | ABDr. Anna BeckerField medical (MSL) | dueDate | Draft → In progress | — | UI | AUD-002001 sess-adda · 10.12.17.51 · #cd08… |
| 05 Sept 2026, 09:57 UTC | Engagement · ENG-0080 | Update | MTMei TanakaField medical (MSL) | topics | In progress → In progress | — | Integration | AUD-002025 sess-a48c · 10.12.8.61 · #c503… |
| 05 Sept 2026, 09:54 UTC | Insight · INS-0050 | Create | PRDr. Priya RamanGlobal medical lead | summary | Draft → Reviewed | — | Integration | AUD-002024 sess-7fdf · 10.12.16.114 · #c403… |
| 05 Sept 2026, 09:41 UTC | Initiative · INI-0026 | Create | ABDr. Anna BeckerField medical (MSL) | notes | Draft → Reviewed | — | UI | AUD-002032 sess-d748 · 10.12.18.87 · #c405… |
| 05 Sept 2026, 07:00 UTC | Task · T-0060 | Update | LOLuis OrtegaField medical (MSL) | notes | In progress → Completed | — | UI | AUD-002086 sess-1cd6 · 10.12.6.125 · #d61b… |
| 05 Sept 2026, 06:51 UTC | Inquiry · MI-2026-0075 | Update | JWJames WhitfieldField medical (MSL) | progress | — → Completed | — | UI | AUD-002011 sess-258e · 10.12.10.200 · #d10a… |
| 04 Sept 2026, 17:19 UTC | Insight · INS-0078 | Update | PRDr. Priya RamanGlobal medical lead | summary | — → Submitted | — | UI | AUD-002108 sess-c41d · 10.12.1.184 · #43dc… |
| 04 Sept 2026, 17:12 UTC | Task · T-0061 | Create | MTMei TanakaField medical (MSL) | notes | — → Submitted | — | UI | AUD-002118 sess-bba4 · 10.12.11.161 · #3dda… |
| 04 Sept 2026, 16:47 UTC | Engagement · ENG-0085 | Create | LOLuis OrtegaField medical (MSL) | progress | Planned → Submitted | — | Integration | AUD-002027 sess-7424 · 10.12.8.40 · #c703… |
| 04 Sept 2026, 16:39 UTC | Task · T-0057 | Close | JWJames WhitfieldField medical (MSL) | summary | Planned → Completed | — | UI | AUD-002132 sess-ee2d · 10.12.9.163 · #afdf… |
| 04 Sept 2026, 15:32 UTC | Initiative · INI-0045 | Create | JWJames WhitfieldField medical (MSL) | dueDate | Draft → In progress | — | Integration | AUD-002155 sess-2b9f · 10.12.13.133 · #b2d0… |
| 04 Sept 2026, 13:20 UTC | Engagement · ENG-0115 | Update | RARachel AdeyemiField medical (MSL) | progress | Draft → Submitted | — | UI | AUD-002065 sess-9b82 · 10.12.12.48 · #550d… |
| 04 Sept 2026, 09:02 UTC | Task · T-0015 | Update | GNGrace NakamuraMedical operations | status | — → Submitted | — | Integration | AUD-002076 sess-62d8 · 10.12.13.231 · #580f… |
| 04 Sept 2026, 08:50 UTC | Inquiry · MI-2026-0053 | Create | GNGrace NakamuraMedical operations | notes | In progress → In progress | — | Integration | AUD-002052 sess-2d20 · 10.12.13.13 · #cc14… |
| 04 Sept 2026, 06:42 UTC | Engagement · ENG-0116 | Create | JWJames WhitfieldField medical (MSL) | topics | — → In progress | — | UI | AUD-002148 sess-f6a3 · 10.12.18.180 · #bbd2… |
| 04 Sept 2026, 06:06 UTC | Inquiry · MI-2026-0046 | Create | GNGrace NakamuraMedical operations | dueDate | Planned → Reviewed | — | API | AUD-002094 sess-9e90 · 10.12.19.72 · #461e… |
| 03 Sept 2026, 18:54 UTC | Insight · INS-0052 | Update | RARachel AdeyemiField medical (MSL) | status | In progress → In progress | — | UI | AUD-002071 sess-59b5 · 10.12.10.167 · #5d0f… |
| 03 Sept 2026, 18:54 UTC | Initiative · INI-0087 | Update | MTMei TanakaField medical (MSL) | progress | Draft → Submitted | — | UI | AUD-002149 sess-b7e3 · 10.12.8.21 · #bad2… |
| 03 Sept 2026, 18:51 UTC | Publication · PUB-0072 | Update | RARachel AdeyemiField medical (MSL) | summary | Draft → Submitted | — | Integration | AUD-002097 sess-f942 · 10.12.3.86 · #471e… |
| 03 Sept 2026, 17:57 UTC | Engagement · ENG-0060 | Update | GNGrace NakamuraMedical operations | progress | — → Submitted | — | UI | AUD-002109 sess-9a0c · 10.12.14.158 · #42dc… |
| 03 Sept 2026, 17:20 UTC | Publication · PUB-0040 | Close | MTMei TanakaField medical (MSL) | notes | — → Reviewed | — | UI | AUD-002026 sess-830c · 10.12.8.70 · #c603… |
| 03 Sept 2026, 17:04 UTC | Insight · INS-0097 | Update | JWJames WhitfieldField medical (MSL) | topics | In progress → In progress | — | UI | AUD-002020 sess-4d32 · 10.12.1.172 · #c003… |
| 03 Sept 2026, 16:50 UTC | Initiative · INI-0077 | Close | LOLuis OrtegaField medical (MSL) | dueDate | — → Reviewed | — | UI | AUD-002005 sess-eca4 · 10.12.16.155 · #c908… |
| 03 Sept 2026, 15:09 UTC | Initiative · INI-0041 | Update | RARachel AdeyemiField medical (MSL) | status | Draft → Submitted | — | API | AUD-002068 sess-9575 · 10.12.15.221 · #500d… |
| 03 Sept 2026, 14:44 UTC | Insight · INS-0017 | Create | MTMei TanakaField medical (MSL) | dueDate | — → In progress | — | UI | AUD-002123 sess-5625 · 10.12.11.122 · #b8e1… |
| 03 Sept 2026, 14:40 UTC | Inquiry · MI-2026-0102 | Update | MTMei TanakaField medical (MSL) | status | — → Completed | — | API | AUD-002120 sess-14c8 · 10.12.19.250 · #b7e1… |
| 03 Sept 2026, 14:35 UTC | Inquiry · MI-2026-0069 | Update | LOLuis OrtegaField medical (MSL) | topics | Planned → Submitted | — | UI | AUD-002106 sess-cc19 · 10.12.8.118 · #45dc… |
| 03 Sept 2026, 13:26 UTC | Publication · PUB-0054 | Close | ABDr. Anna BeckerField medical (MSL) | dueDate | In progress → Completed | — | UI | AUD-002136 sess-6cb4 · 10.12.1.219 · #b3df… |
| 03 Sept 2026, 12:52 UTC | Publication · PUB-0095 | Close | DCDavid ChenMedical communications | dueDate | Draft → In progress | — | UI | AUD-002049 sess-a65 · 10.12.4.148 · #4d11… |
| 03 Sept 2026, 11:34 UTC | Initiative · INI-0044 | Update | LOLuis OrtegaField medical (MSL) | notes | — → Submitted | — | UI | AUD-002085 sess-3dc1 · 10.12.10.240 · #d91b… |
| 03 Sept 2026, 11:09 UTC | Insight · INS-0112 | Close | LOLuis OrtegaField medical (MSL) | progress | Planned → Completed | — | UI | AUD-002088 sess-ea52 · 10.12.1.160 · #d41b… |
| 03 Sept 2026, 10:40 UTC | Inquiry · MI-2026-0045 | Update | FAFatima Al-SayedMedical information | notes | Planned → Reviewed | — | Integration | AUD-002127 sess-edaa · 10.12.8.211 · #b4e1… |
| 03 Sept 2026, 09:32 UTC | Task · T-0113 | Create | FAFatima Al-SayedMedical information | notes | In progress → Reviewed | — | UI | AUD-002059 sess-34e6 · 10.12.4.184 · #d114… |
| 03 Sept 2026, 08:12 UTC | Publication · PUB-0061 | Close | ABDr. Anna BeckerField medical (MSL) | progress | Draft → Completed | — | API | AUD-002129 sess-68a3 · 10.12.18.11 · #bee1… |
| 03 Sept 2026, 07:30 UTC | Inquiry · MI-2026-0071 | Update | PRDr. Priya RamanGlobal medical lead | dueDate | Planned → Submitted | — | UI | AUD-002045 sess-c864 · 10.12.15.140 · #4911… |
| 03 Sept 2026, 07:29 UTC | Publication · PUB-0113 | Update | LOLuis OrtegaField medical (MSL) | topics | Planned → In progress | — | UI | AUD-002082 sess-bba0 · 10.12.8.241 · #da1b… |
| 02 Sept 2026, 17:35 UTC | Initiative · INI-0071 | Update | JWJames WhitfieldField medical (MSL) | topics | — → Completed | — | API | AUD-002029 sess-d1a · 10.12.17.165 · #c903… |
| 02 Sept 2026, 16:27 UTC | Task · T-0010 | Update | JWJames WhitfieldField medical (MSL) | dueDate | — → Submitted | — | UI | AUD-002116 sess-f598 · 10.12.18.157 · #43da… |
| 02 Sept 2026, 15:08 UTC | Task · T-0090 | Create | PRDr. Priya RamanGlobal medical lead | progress | Draft → Submitted | — | UI | AUD-002004 sess-85b5 · 10.12.7.185 · #c808… |
| 02 Sept 2026, 14:27 UTC | Insight · INS-0095 | Update | MTMei TanakaField medical (MSL) | summary | Draft → Completed | — | UI | AUD-002050 sess-f9 · 10.12.12.27 · #ca14… |
| 02 Sept 2026, 13:53 UTC | Engagement · ENG-0094 | Update | FAFatima Al-SayedMedical information | dueDate | In progress → Submitted | — | Integration | AUD-002096 sess-2c81 · 10.12.17.217 · #481e… |
| 02 Sept 2026, 13:44 UTC | Publication · PUB-0019 | Close | FAFatima Al-SayedMedical information | progress | — → Completed | — | UI | AUD-002104 sess-752f · 10.12.19.73 · #47dc… |
Suggestions (30 days)
Accepted
Corrected
Rejected
Acceptance rate
Pending review
| Feature | Intended use | Prohibited use | Model version | Human review | Evaluation (P / R) | Last evaluated | Status |
|---|---|---|---|---|---|---|---|
| Insight summary AI-generated | Draft a neutral summary of free-text insight notes with quoted source spans | Generating scientific claims or promotional wording | helixor-private-llm-2026.08 | Required | 0.91 / 0.87 | 28 Aug 2026 | Enabled |
| Topic classification AI-generated | Suggest an insight category from taxonomy v3 | Auto-applying a category without reviewer confirmation | helixor-private-llm-2026.08 | Required | 0.88 / 0.84 | 28 Aug 2026 | Enabled |
| Duplicate detection AI-generated | Flag likely duplicate insights and stakeholders for review | Merging or deleting records automatically | helixor-embed-v2 | Required | 0.94 / 0.79 | 15 Jul 2026 | Enabled |
| Executive narrative AI-generated | Draft narrative paragraphs from approved metric values with citations | Distribution without named human approval; use with unapproved metrics | helixor-private-llm-2026.08 | Required | 0.82 / 0.80 | 01 Sept 2026 | Enabled |
| Inquiry categorisation AI-generated | Suggest inquiry category and urgency for triage | Drafting or sending medical responses; safety triage decisions | helixor-private-llm-2026.08 | Required | 0.90 / 0.86 | 10 Aug 2026 | Enabled |
| Timestamp | Feature | Model | Record | User | Outcome | Confidence |
|---|---|---|---|---|---|---|
| 14 Sept 2026, 11:02 UTC | Insight summary | helixor-private-llm-2026.08 | Insight · INS-0061 | RARachel Adeyemi | Pending review | 0.79 |
| 13 Sept 2026, 04:31 UTC | Topic classification | helixor-private-llm-2026.08 | Insight · INS-0060 | MTMei Tanaka | Pending review | 0.88 |
| 12 Sept 2026, 09:10 UTC | Insight summary | helixor-private-llm-2026.08 | Insight · INS-0047 | PRDr. Priya Raman | Corrected | 0.86 |
| 10 Sept 2026, 06:00 UTC | Executive narrative | helixor-private-llm-2026.08 | Report · RPT-Q3-EXEC | GNGrace Nakamura | Pending review | 0.74 |
| 08 Sept 2026, 09:12 UTC | Duplicate detection | helixor-embed-v2 | Insight · INS-0055 | FAFatima Al-Sayed | Accepted | 0.94 |
| 07 Sept 2026, 14:20 UTC | Inquiry categorisation | helixor-private-llm-2026.08 | Inquiry · MI-2026-0788 | FAFatima Al-Sayed | Accepted | 0.91 |
| 05 Sept 2026, 10:00 UTC | Topic classification | helixor-private-llm-2026.08 | Insight · INS-0052 | LOLuis Ortega | Rejected | 0.58 |
Data handling
Positioning
| Deliverable | Status | Note | |
|---|---|---|---|
| Intended-use statement template | Template | Customer completes for their process scope | |
| Risk assessment (GAMP 5 category 4) | Available | Vendor assessment; customer adds process risks | |
| User requirements specification (URS) | Available | Mapped to PRD sections | |
| Functional specification (FS) | Available | Per release | |
| Configuration specification (CS) | Template | Documents tenant configuration decisions | |
| Traceability matrix | Available | URS → FS → test scripts | |
| Test scripts (OQ) | Available | Executable in the validation tenant | |
| Test evidence export | Available | Screenshots, logs and signatures per script | |
| Release notes with impact assessment | Available | Every release | |
| Change control procedure | Template | Aligned to customer SOP | |
| Validation impact assessment per release | Available | Classifies changes as none / minor / major | |
| Periodic review record | Template | Annual |
| Principle | How the system supports it |
|---|---|
| Attributable | Every change records the authenticated user, role and session; integrations run under named service identities. |
| Legible | Audit entries store field, previous and new value in readable form; exports render as PDF and CSV. |
| Contemporaneous | Server timestamps in UTC at the moment of the change; client clocks are not trusted. |
| Original | Source records from integrations keep the original payload id and sync time; originals are never overwritten. |
| Accurate | Validation rules, controlled taxonomies and data-quality monitoring; corrections keep the prior value. |
| Complete | Append-only trail includes creates, updates, deletes, approvals, signatures, exports and overrides. |
| Consistent | One event schema across modules; sequence preserved by chained hashes. |
| Enduring | Retention policies per record class; audit trail retained for the configured period beyond record deletion. |
| Available | Searchable in the UI and exportable as an evidence package on demand. |
Sample signature event
AUD-000902 · 20 Jan 2026, 14:02 UTC · Medical plan MP-2026-VTX-G · Meaning: Approval · Re-authenticated
| Level | Examples | Access | Export | Retention | AI processing |
|---|---|---|---|---|---|
| Public | Published articles, congress names | All roles | Unrestricted | Indefinite | Allowed |
| Internal | Plans, objectives, metrics | Scoped by product and geography | Logged | 7 years after archive | Allowed (tenant model) |
| Confidential | Insights, engagement notes, budgets | Role and scope | Logged; approval for bulk export | 7 years | Allowed with source-span display |
| Restricted | Safety-flagged insights, pseudonymised stakeholder data | Named roles only | Compliance approval; watermarked | Per PV and privacy policy | Summarisation only; no classification |
| Commercially sensitive | Pre-approval launch dates, pricing context | Executive and named leads | Blocked by default | Until public then Internal | Not processed |