| File | What it is | Why we need it |
|---|
| ① Workstream trackers (the family) |
| Investment Activity | Date-by-date $2M@$8M seed plan, 5 gates (G0→G4), investor pipeline + doc library. | Run and diligence the raise. |
| Patent Filing | 8 India provisionals, FD 26 Jun, §39 window, QC + IPflair library. | Protect the IP moat; hold filing deadlines. |
| Development & Demo | Phase 1A/1B/2/3 build map, 6+1 demo, gap tickets, code audit @HEAD. | Track build to 26 Jun demo + Sep-01 verified build. |
| Pilot Launch | India pilot: regulatory items, FDA boundary, team/GTM, Day-90 gate. | Run the India pilot to first logos. |
| Go-To-Market | Two-lane motion, design-partner pipeline/ICP, 12 workstreams. | Drive commercial motion + partner conversion. |
| Product Roadmap | All 70 module specs, filter/sort/search. | Prove the full GxP suite. |
| Dataset | Synthetic 43/29.7M + gold corpus + demo-seed mapping. | Evidence demo seed + validation data lineage. |
| QMS / Validation | 69 SOPs + 37 WIs (file-linked), validation lifecycle, reg map. | Activate QMS + answer pharma-QA / technical DD. |
| Security & Trust | Pentest register v8.1 (6 defects/9 gates), SOC 2 / ISO readiness. | Security DD + buyer security review. |
| Legal & Entity | 3-phase legal set (17/12/4), entities, IP-assignment chain. | Corporate + IP execution (Gate-1 / FD). |
| Demo Scenarios & Acceptance (6+1) | 77 acceptance criteria, Part-A story, demo readiness. | The demo script + per-control acceptance criteria. |
| Master Tracker | Hub: cards ①–⑩ + cross-workstream hard dates. | Single entry point to the family. |
| Regulatory & Compliance Intelligence | 52 GxP frameworks (GMP·GCP·GLP·GDP·GVP, data integrity, CSV/AI, ICH, submissions/biologics, India, privacy, IP), mapped to SOP/URS controls. | Track applicable regulations/guidance/laws + AI-era horizon scan. |
| Events Tracker — Marketing/Leads (IN · US · EU) | 53 events with HIGH/MED-HIGH/MED/SPEC ROI tagging + 7-step action plan + urgent banner. India HIGH: ET Pharma Tech Conclave (24 Jul Hyderabad · URGENT) · iPHEX (Sep 2026 Bharat Mandapam) · CPHI India + PMEC India (Nov 2026) · BioAsia 2027 · ISPE India Pharma 4.0 (Apr 2027). US HIGH: PDA/FDA Joint Regulatory (14-16 Sep 2026 DC) · Veeva R&D + Quality Summit US (Oct 2026 Boston) · FDLI Annual (May 2027 · CFP opens 17 Aug) · INTERPHEX 2027 (Apr NYC) · CPHI Americas 2027 (May Miami) · DCAT Week (Mar 2027 NYC). EU HIGH: Annex 22 / AI Conference (Oct 2026 ECA) · CPHI Worldwide (Nov 2026 Frankfurt) · DIA Europe (Mar 2027 Basel) · BIO-Europe (Nov 2026 Cologne) · PharmaLab (Nov 2026 Darmstadt). Webinar: KENX (12 Aug-11 Nov 2026 · URGENT pitch). Urgent: AIPM poster 30 Jun · ET Pharma 24 Jul · FDLI CFP 17 Aug · KENX 12 Aug. | Drive founder speaker pipeline + private DP meetings + CFP submissions across all three regulatory regimes. Anti-drift: 7-step action-plan timeline embedded. |
| 📄 Source data · Marketing event research (md) | Backing research for the Marketing Events Tracker · 30 KB · 18 priority ranking table + India/US/EU breakdowns + AAPS / INTERPHEX / CPHI Americas / NASSCOM fit answers + 7-step action plan. Source-of-truth for any added/dropped marketing event with citations. | Audit trail for marketing-event decisions and CFP commitments. |
| 📄 Source data · Investor event research (md) | Backing research for the Investor Events Tracker · 47 KB · Top-12 priority ranking + US/EU/India/Accelerator/Global tables + 6 direct-question answers (BIO Investor Forum, HLTH, Slush, India, EIT, LSX) + 4-step action plan + verified-weak avoidance list. Source-of-truth for any added/dropped investor event with citations. | Audit trail for investor-event decisions and pitch commitments. |
| Investor Events Tracker (IN · US · EU) | 42 investor events + 7 membership/network channels with HIGH/MED-HIGH/MED/SPEC ROI tagging + Top-12 priority ranking + 4-step action plan + "Do NOT prioritize" verified-weak list. US HIGH: JPM Healthcare + RESI JPM (Jan 2027 SF · gap-filling) · HLTH Startup Pitch (Nov 2026 Vegas · judges a16z+GV+Khosla+Cigna Ventures) · Rock Health Summit (Oct 2026 SF) · DHIS East + Cooley Capital Call · J&J JLABS Investor Day. EU HIGH: BIO-Europe (Nov 2026 Cologne partneringONE®) · Slush (Nov 2026 Helsinki · 3,300 investors) · LSX World Congress Europe 2027 Lyon (seed-Series B). India HIGH: India Pharma Conference 2027 (FICCI DoP IPA) · C-CAMP NBEC (INR 20Cr) · BTS Future Makers · TiE iDay + The Knot · Bharat AI Innovation Healthcare AI. Global: Biotechgate Digital Partnering · BIO Investment & Growth Summit 2027 Miami (BIO Investor Forum replacement). $2M@$8M seed pipeline events. | Map investor surfaces for the seed raise. Investor Activity Tracker remains source of truth for named investor pipeline + close-status. |
| ② Live Phase-1 demo / pilot flow diagrams (current — FINAL 2026-06-02) |
| Deviation → RCA → CAPA end-to-end | Continuous quality-event UI thread, screen by screen. | Blueprint for the core demo thread + build spec. |
| Deviation complete user flow (Sai+Anita) | Full deviation create→triage→close UX with SoD. | Deviation UX/acceptance spec. |
| Batch disposition arm (critical deviation) | Critical-deviation → batch disposition branch + seeded batch linkage. | Designs the critical-path branch + batch_id seed. |
| Deviation ↔ OOS cross-reference (optional) | Optional OOS↔deviation linkage design. | Reference for OOS linkage; optional in demo. |
| SOP from AI generation (URS-12 + URS-32 MIRA) | MIRA-assisted SOP authoring (advisory, human-authored). | Doc-control demo beat #4 + AI-governance proof. |
| New SOP from scratch (URS-12) | Manual controlled-document creation. | Doc-control baseline UX spec. |
| SOP from template → approved (URS-12) | Template happy-path to approval/e-sign. | Doc-control approval/e-sig demo path. |
| SOP template → rejected + recovery (URS-12) | Rejection + recovery branch. | Negative-path UX spec. |
| Upload document (.docx + .pdf) | Controlled upload + MIRA-review intake. | Doc intake UX + DQG linkage. |
| ③ Lifecycle, index & specification HTML |
| End-to-end GxP SaaS lifecycle | URS→Build→Test→Release→Validation→Customer→Change-Control. | Master SDLC/validation narrative for QMS + DD. |
| URS 1–41 canonical index | Linked index of all 41 Target-State URS modules. | Navigate the URS corpus behind roadmap + QMS. |
| Demo flow: claim vs code vs URS | Per-claim reconciliation claim↔code↔URS. | Inspection-grade proof demo claims are true-in-code. |
| India pilot launch playbook (Apr 25) | Earlier India pilot launch plan. | Source feeding the Pilot Launch tracker. |
| Seed fundraising flow ($2M@$8M) | Step-by-step raise process + artifacts. | Process map behind the Investment tracker. |
| Pentest execution guide v8.1 | Tester-facing HTML render of the plan. | Execution doc for the authorized pentest. v8.0 SUPERSEDED. |
| Validate Dataset index (legacy, light) | Older light index of gold/validate corpus. | SUPERSEDED by the Dataset tracker; kept for history. |
| ④ Website & marketing HTML (migrated / legacy) |
| Verixa marketing site v3 (latest) | Public marketing site draft, current. | Public positioning draft; latest website. |
| Verixa marketing site v2 | Prior website draft. | SUPERSEDED by v3. |
| Navira QA services site | GxP compliance-services site (predecessor brand). | Legacy services positioning. |
| Expert-network outreach templates | Outreach copy templates. | Legacy GTM outreach reference. |
| ⑤ Reference & archive HTML (read-only / superseded history) |
| Patent case-law: Alice + KSR, Bilski, Mayo, eBay (5 US) | Downloaded landmark US software/eligibility rulings. | §101 / CRI patent-strategy reference. |
| Patent case-law: India — Monsanto + Merck v Glenmark (2) | Indian landmark patent rulings. | India §3(k)/CRI eligibility reference. |
| Indian Patent Rules 2003 (updated 2024) | Current Indian Patent Rules text (+ raw copy). | Filing-compliance reference for FD + prosecution. |
| URS archive workflow diagrams (9) | Historical URS workflow diagrams in _Source_Archives. | SUPERSEDED by current URS specs + Phase-1 FINAL flows. |