Verixa β QMS / Validation & Compliance Tracker
π Patent-filing date realignment Β· 18 Jun β 26 Jun β 03 Jul 2026
Patent FD target shifted from 15 Jun 2026 to 26 Jun 2026 03 Jul 2026. All FD+N statutory and decision dates shift accordingly: Β§39 clock starts 26 Jun 03 Jul Β· complete specifications due 26 Jun 2027 03 Jul 2027 (Β§9(1)) Β· PCT decision 26 Dec 2026 03 Jan 2027 Β· US/EU national-phase entry 26 Dec 2028 03 Jan 2029 Β· Request for Examination 26 Jan 2029 03 Feb 2029. Marketing public-disclosure window also shifts: founder 1-to-1 outbound to known DP targets continues pre-FD under NDA; public marketing (newsletter Β· pillar pages Β· founder LinkedIn cadence Β· PR note Β· webinar invites) unlocks Mon 29 Jun 2026 Tue 07 Jul 2026 (W5) post-FD. Engineering W1-W14 pilot timeline holds: demo lock Fri 26 Jun Β· Verified Go-Live Decision Tue 01 Sep.
GAMP 5 Category 5 GxP system Β· 69 SOPs + 37 work instructions (v1.0 DRAFT) Β· Validation Harness v1.0.1-GO Β· Commercial Pilot Verification Plan Β· 41 Target-State URS Β· development phase β no change control until verified, tested & validated Β· updated 2026-06-25 (independent QA/CSV reviewer sourcing added β pre-pilot gate)
69
SOPs authored (v1.0 DRAFT)
41
Target-State URS modules
v1.0.1-GO
Validation Harness (framework approved)
IQ/OQ/PQ
risk-based CSA per VRX-SOP-202
0
SOPs effective yet β all DRAFT
QMS / Validation Document Library