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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.
ID Audit Trail
AssayCore Micro · Organism identification · 21 CFR Part 11 §11.10(e) · CLSI MM18-A2
IDs logged today
24
Confidence ≥ 95%
11
Manual overrides
4
21 CFR signed
17
MALDI Biotyper score thresholds: ≥ 2.300 = highly probable species-level ID; 2.000–2.299 = secure genus, probable species; < 2.000 = not reliable — confirm by 16S sequencing (CLSI MM18-A2). 21 CFR Part 11 §11.10(e): audit trail with operator ID, timestamp, action logged for all e-records.
| Audit ID | Isolate | Organism (Hit #1) | Library | Hit #1 Score | Hit #2 Score | Confidence | Override | e-Sig (21 CFR) | Operator | Date |
|---|---|---|---|---|---|---|---|---|---|---|
| IDAUD-0001 | ISO-8757 | Staphylococcus epidermidis | NCBI BLAST+ 2.14 | 2.31 | 2.14 | 92% | — | 21 CFR Signed | Mark Li | 2026-04-16 |
| IDAUD-0002 | ISO-2053 | Aspergillus brasiliensis | NCBI BLAST+ 2.14 | 2.37 | 1.94 | 83% | — | 21 CFR Signed | Anya Fischer | 2026-04-15 |
| IDAUD-0003 | ISO-5849 | Escherichia coli | Accugenix AccuPRO-ID | 2.43 | 2.11 | 84% | — | 21 CFR Signed | Mark Li | 2026-04-16 |
| IDAUD-0004 | ISO-6032 | Staphylococcus aureus | MALDI Biotyper (Bruker) | 2.40 | 2.20 | 99% | — | Not Required | Dr. Elena Vasquez | 2026-04-17 |
| IDAUD-0005 | ISO-6257 | Staphylococcus aureus | NCBI BLAST+ 2.14 | 2.42 | 2.16 | 95% | — | 21 CFR Signed | Tom Brennan | 2026-04-15 |
| IDAUD-0006 | ISO-7145 | Salmonella typhimurium | Accugenix AccuPRO-ID | 2.42 | 2.14 | 87% | — | 21 CFR Signed | Mark Li | 2026-04-16 |
| IDAUD-0007 | ISO-2159 | Aspergillus brasiliensis | Accugenix AccuPRO-ID | 2.29 | 2.00 | 97% | — | 21 CFR Signed | Priya Sharma | 2026-04-18 |
| IDAUD-0008 | ISO-9700 | Bacillus subtilis | Accugenix AccuPRO-ID | 2.42 | 2.24 | 95% | — | 21 CFR Signed | Priya Sharma | 2026-04-14 |
| IDAUD-0009 | ISO-5430 | Bacillus subtilis | Accugenix AccuPRO-ID | 2.41 | 2.21 | 90% | — | 21 CFR Signed | Anya Fischer | 2026-04-15 |
| IDAUD-0010 | ISO-3236 | Staphylococcus aureus | Accugenix AccuPRO-ID | 2.45 | 2.16 | 93% | — | 21 CFR Signed | Tom Brennan | 2026-04-15 |
| IDAUD-0011 | ISO-2972 | Salmonella typhimurium | MALDI Biotyper (Bruker) | 2.44 | 2.20 | 97% | — | 21 CFR Signed | Anya Fischer | 2026-04-19 |
| IDAUD-0012 | ISO-7837 | Staphylococcus epidermidis | NCBI BLAST+ 2.14 | 2.39 | 2.16 | 88% | — | Signature Pending | Dr. Elena Vasquez | 2026-04-16 |
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