DEMO MODE· Read-only demo with synthetic dataLearn more on assaycore.pro
Compliance
ISO 15189ISO 11133ISO 11737EUCAST v16.0CLSI M100-S34EU GMP Annex 1USP <71>

Interactive marketing demo running on Vercel with mock data. Click any feature to explore — no account needed.

Production stack for AssayCore Micro

Core: PostgreSQL 16 + Redis 7 + Kafka 3.7 + MinIO + Keycloak 24 + Spring Boot 3.3 (Kotlin) + React 18/MUI + FastAPI ML (Python 3.11) + Nginx + Docker

Module-specific: PyTorch 2.x + YOLOv8 + OpenCV colony AI · EUCAST v16 / CLSI M100-S34 AST breakpoints · AMR expert rules (EUCAST v3.4) · VITEK/MALDI-TOF/ASTM bridges · EM trending dashboard with alert/action limits (EU GMP Annex 1)

Deployable on your infrastructure or our managed Hetzner. Self-hosted source-license available.

Environmental Qualification

AssayCore Micro · DQ/IQ/OQ/PQ lifecycle · ISPE Baseline Vol. 3 · EU GMP Annex 15 · ICH Q9

Cleanrooms qualified

3

Re-qualifications due

7

IQ/OQ/PQ complete

10

CCS deviations

9

ISPE Baseline Vol. 3 / EU GMP Annex 15: DQ = Design Qualification (design intent documented); IQ = Installation Qualification; OQ = Operational Qualification (range of operation tested); PQ = Performance Qualification (routine operation). Annual re-qualification mandatory per EU GMP Annex 1 (2022) §4.4. CCS = Contamination Control Strategy per Annex 1 §4.37.
Room IDDesignationClassDQIQOQPQNext Re-qualCCS DeviationsStatusLead
CR-A-001Filling Isolator Suite — Grade A/BGrade ADQIQOQPQ2026-06-010Re-qual DuePriya Sharma
CR-A-002LAF Workstation Area — Grade AGrade ADQIQOQPQ2026-06-010Re-qual DueMark Li
CR-B-001Aseptic Processing Suite — Grade BGrade BDQIQOQPQ2026-05-014Re-qual DueMark Li
CR-B-002Vial Filling Background — Grade BGrade BDQIQOQPQ2026-03-010OverdueMark Li
CR-C-001Preparation Suite — Grade CGrade CDQIQOQPQ2026-11-010QualifiedDr. Elena Vasquez
CR-C-002Component Washing — Grade CGrade CDQIQOQPQ2026-09-010QualifiedTom Brennan
CR-C-003Solution Prep Lab — Grade CGrade CDQIQOQPQ2026-05-012Re-qual DueDr. Elena Vasquez
CR-D-001Dispensary Area — Grade DGrade DDQIQOQPQ2026-10-010QualifiedAnya Fischer
CR-D-002Packaging Corridor — Grade DGrade DDQIQOQPQ2026-07-010Re-qual DueTom Brennan
CR-D-003Material Airlock — Grade DGrade DDQIQOQPQ2026-03-013OverdueAnya Fischer