AI-powered LIMS for regulated labs.
Deployed on YOUR server in 14 days.
8 specialized modules with 24 production ML models bundled - Med · Food · Cosmetics · Micro · Agro · Vet · Env · Tracker. Kotlin + Postgres + Keycloak on your infrastructure. ISO 17025 · 21 CFR Part 11 · MoCRA · EUCAST v16 (Jan 2026) · FSMA-204 · GxP-ready.
Why labs switch to AssayCore
Specific pains we close - backed by enforcement letters, accreditation cycles, and verified competitor pricing.
Recent FDA / regulatory fine?
Audit-trail logs every step automatically - most findings around document control, e-signatures, and version history are closed by Day 1 of go-live.
Locked into LabWare / STARLIMS / LabVantage?
Migrate off in 30 days, zero data loss. Typical TCO 40-60% lower than enterprise LIMS at equivalent ISO 17025 / Part 11 scope.
ISO 17025 / 15189 / 22716 renewal soon?
Pre-configured templates, controlled documents, traceability matrix. Teams typically pass in one audit.
Still on spreadsheets?
A single audit finding on version control costs accreditation. We replace Excel-based QC in 14 days, on your server.
Data must stay on your infra?
Postgres + Keycloak + MinIO - fully self-hosted. No vendor data processing. GDPR Art. 32, HIPAA BAA available.
Techs typing chromatograph results into LIMS?
HL7v2, ASTM E1394, FHIR R4 + parsers for ICP-OES, GC-MS, NIR, ELISA, MALDI-TOF. Bidirectional, auto-import.
Why it's worth the price
We do not sell raw tables. Every deployment ships with trained models, SOP-driven UX, and regulatory spines that normally take months to build.
Trained on real lab workflows
24 CPU-only ML models + 35 Hugging Face datasets bundled: hematology cell classification, colony morphology CNN, allergen cross-contamination scorer, CPNP PIF parser, soil NPK predictor, EPA method matcher, HL7v2 field validator, TAT forecaster per analyte.
Co-designed with working lab technicians
Not abstract software. SOP-driven UX built from walkthroughs with real lab techs in Med, Food, Cosmetic, and Micro. Workflows from practice, not from a spec sheet.
Configured per your SOP, not generic templates
Every deployment is parameterized to your lab: reference ranges, critical values, TAT targets, Westgard QC rules per analyte, report templates, SOP versioning.
8 modules, each with its own regulatory spine
Med = ISO 15189 + HL7v2/FHIR R4 + CLIA · Food = HACCP + USDA/FSIS + ISO 22000 + FSMA · Cosmetic = EU 1223/2009 + ISO 22716 + CPNP + ICH Q1A · Micro = ISO 11133 + EUCAST + CLSI + ISO 11737 · Agro = ISO 10381 + EU MRL 396/2005 + EPA 3050B · Vet = OIE + AVMA + USDA APHIS · Env = EPA 8260B/8270D/200.8/300.0 + NELAP · Tracker = GDP + ISO 15189 sample integrity + 21 CFR Part 11 e-sign.
Eight Modules, One Platform
Each module is a fully autonomous deployment - independent database, authentication, caching, and messaging. Buy one, bundle several, or take the full suite.
AssayCore Med
Comprehensive management of the entire clinical laboratory workflow - from patient registration and sample collection to result verification and report delivery.
- Patient management with full medical history
- Sample lifecycle tracking with barcode/QR generation
- Test ordering with priority levels (Routine, Urgent, STAT)
- Auto-verification with configurable Westgard QC rules
- Levey-Jennings charts and Z-score tracking
- HL7v2 & ASTM E1394 bidirectional instrument integration
- FHIR R4 interoperability with HIS/EMR systems
- Delta check and critical value alerts with escalation
- TAT monitoring dashboard
Compliance
Enterprise-Grade Platform
Built for laboratories that demand reliability, security, and compliance.
Security & Compliance
TLS 1.3 encryption, AES-256 PII protection, complete audit trail supporting FDA 21 CFR Part 11, ISO 17025, and EU GDPR.
Multi-Tenant Architecture
Row-level security with lab_id isolation on every table. Each tenant sees only its own data - guaranteed at the database level.
Flexible Deployment
SaaS cloud platform with Kubernetes auto-scaling, or On-Premise with Docker Compose and native Tauri desktop client for closed networks.
AI/ML Module
24 CPU-only models for anomaly detection, risk scoring, colony recognition, allergen NER, and predictive analytics - no GPU required.
Deep Integration
HL7v2, ASTM E1394, FHIR R4 for instrument and HIS connectivity. Kafka event bus for real-time inter-service communication.
Advanced Reporting
PDF reports via Thymeleaf templates, Excel exports with Apache POI. Scheduled and async report generation with Kafka queues.
Intelligent Search
PostgreSQL pg_trgm fuzzy search with GIN indexes and tsvector full-text search. Redis caching delivers sub-2ms query latency.
Multi-Channel Alerts
In-app, email, SMS, and push notifications with escalation chains. Critical value alerts with delivery tracking and acknowledgment.
ML bundled with every deployment
No GPU required. No external API calls. Models run on your infrastructure against your data. 35 Hugging Face datasets included for fine-tuning per lab.
| Model | Module | Input | Output | Accuracy | Latency |
|---|---|---|---|---|---|
| Hematology cell classifier | Med | Blood smear image | WBC 5-class + count | 94.2% | 180 ms |
| Colony morphology CNN | Micro | Plate photo | Colony segmentation + morphotype | 91.5% | 320 ms |
| Allergen cross-contamination scorer | Food | ATP biolum + batch context | Risk score 0-100 | AUC 0.89 | 12 ms |
| CPNP PIF parser | Cosmetic | PIF text + formula | Structured CPNP XML | 96.0% | 240 ms |
| Soil NPK predictor | Agro | NIR spectrum | N / P / K / OM% | R² 0.87 | 45 ms |
| EPA method matcher | Env | Analyte + matrix | Ranked methods (8260B/8270D/200.8) | top-1 88% | 8 ms |
| HL7v2 field validator | Med | HL7v2 message | Valid / invalid + field issues | 99.1% | 22 ms |
| TAT forecaster | All | Sample type + load + analyzer state | Expected TAT minutes + CI | MAE 11 min | 30 ms |
| Gram stain classifier | Micro | Slide image | Gram +/- + morphology | 92.8% | 190 ms |
| Critical value delta detector | Med | Result + patient history | Critical / flagged / normal | F1 0.93 | 15 ms |
| Shelf-life predictor | Food | Stability + storage conditions | Predicted expiry + confidence | MAE 3.2 d | 40 ms |
| Stability ICH Q1A extrapolator | Cosmetic | Accelerated + real-time data | Long-term projection 36 mo | MAE 4% | 60 ms |
| Species-specific reference ranger | Vet | Species + age + test | Reference interval | coverage 99.5% | 5 ms |
| MRL compliance flagger | Agro | Pesticide + crop + market | Pass / fail vs EU 396/2005 / Codex | 100% rule-based | 3 ms |
| Herd outbreak detector | Vet | Serology time-series | Outbreak probability | AUC 0.91 | 80 ms |
| Water quality anomaly | Env | Multi-parameter water data | Anomaly + severity | F1 0.88 | 50 ms |
| CoA auto-generator | Food | Test results + template | Formatted CoA PDF | 98.5% no-rework | 400 ms |
| Sample integrity scorer | Tracker | Temperature excursions + time | Integrity 0-100 | MAE 4 pt | 20 ms |
| QC Westgard rule engine | Med | QC run series | Violation flags | 100% rule-based | 6 ms |
| EUCAST AST interpreter | Micro | MIC / zone + organism | S / I / R + resistance | 100% per v14 | 4 ms |
| Inventory reorder predictor | Food | Usage + lead time | Reorder date + qty | MAE 1.8 d | 30 ms |
| Allergen NER | Food | Product description | Entities: 26 EU + Big-9 | F1 0.96 | 70 ms |
| NELAP scope auto-extender | Env | Methods + state list | Scope matrix + gaps | Exact | 100 ms |
| Instrument downtime predictor | Med | Analyzer telemetry | Failure probability 48h | AUC 0.84 | 55 ms |
All tiers include 3 months of post-deploy support, 10 training seats, IQ/OQ/PQ scripts, source-code escrow option, and SLA-backed P1/P2 response.
Built for Regulatory Compliance
AssayCore is designed to meet the strictest international laboratory standards across all 8 modules.
Modern Technology Stack
Built with battle-tested technologies, designed for performance and maintainability.
Backend
Frontend
Infrastructure
AI / ML
How implementation works
Predictable timelines · fixed scope · 3-month post-deploy support included.
Managed SaaS
Hosted by AssayCore on EU/US infrastructure. We handle ops, backups, monitoring. $59-$249 per user/mo + $12,900 setup.
On-Premise
Deployed on YOUR server (bare-metal / VM / private cloud). Your DB, your runbook, our maintenance contract. $19,900-$129,900+.
Customer Cloud
Deployed on your AWS / Azure / GCP / Hetzner / OVH account. We commit infrastructure-as-code, you keep ownership.
Boxed (one-time license)
Perpetual license + 20% annual support. For labs that must own software outright (government, defense, certain MedTech).
Timeline by tier
Standard - 14 to 21 days
Professional - 21 to 35 days
Enterprise - 35 to 60 days
Every deployment includes
- Setup, environment & SSL
- Schema migration from your existing system (Excel, LabWare, STARLIMS, etc.)
- Reference data load (analytes, methods, reference ranges, instrument library)
- ML model deployment (24 CPU-only models)
- Analyzer integration assistance (HL7v2, ASTM E1394, FHIR R4)
- Custom workflow configuration to your SOPs
- 3 months post-deploy support (P1 within 4h, P2 within 24h)
- 10 training seats included; UAT & IQ/OQ/PQ scripts
Transparent pricing - no quote-on-call
60% of enterprise LIMS hide their prices. We don't. Pick the entry that fits, bundle if you need more.
Prices in USD. EUR / GBP available on request. Payments processed via Paddle (Merchant of Record).
Presale & quick-deposit SKUs
Most engagements start here - convert 100% to full contractScoping PoC
2 weeks · sandbox + scope doc + migration plan
- Deployed sandbox with your data
- Migration plan from your current system
- Scope document for full build
- 100% credit toward full contract within 90 days
Compliance Audit Sprint (24-48h)
MoCRA / EUCAST v16 / FSMA-204 / IVDR / ISO 17025 — 8-page gap report + corrective-action checklist. Delivered within 48h of payment.
100% credit toward any engagement within 12 months
LIMS Readiness Audit
3 days · 15-page vendor-agnostic PDF
Often converts to Emergency Audit or Scoping within 30 days
Emergency Audit Sprint
5 days · starts Monday · gap analysis + corrective action templates
$4,995 credit toward full engagement
Just one problem? Start with a Quickstart
New · 7-10 daysNot ready for a full LIMS? Pick the specific workflow that's hurting you - CPNP compliance, HACCP CCP, HL7v2 bridging, AST interpretation, or Chain-of-Custody. Fixed scope, fixed price, deployed in one week. 100% credit toward Full Build if you upgrade within 90 days.
Cosmetic CPNP + MoCRA Quickstart
EU CPNP notifications + FDA MoCRA facility/product registration + INCI DB (26 EU allergens, ISO 16128 natural-origin calc) + PIF/CPSR auto-generation. 4 dedicated ML models. 10 days, fixed price.
- EU CPNP XML notification workflow (live in 5 days)
- FDA MoCRA Cosmetics Direct submission packet (Form FDA 5066, biennial renewal automation)
- INCI database (1,020 ingredients) + EU 26 fragrance-allergen flag (auto-detect ≥0.001% rinse-off / ≥0.0001% leave-on)
- ISO 16128 natural-origin calculator + ingredient origin (NO/NOI) classification
- ICH Q1A stability schedule (T₀/T₃₀/T₆₀ tracking, 25°C/40°C chambers)
- PIF / CPSR / TDS / SDS one-click multilingual export (PDF + XML)
- Talc-asbestos testing log (March 2026 FDA final rule ready)
- Adverse-event registry with FDA reporting workflow (since 2024 enforcement)
- 4 production ML models bundled: beauty.toxicity_scorer (AUC 0.82), beauty.allergen_detector (recall 0.90), beauty.solubility, beauty.lipophilicity
- 21 CFR Part 11 audit trail + e-signature
- 8h staff training (recorded Loom + private docs)
- 30 days post-deploy support
- 100% credit → Cosmetic Full Build within 90 days
Med HL7v2 Bridge Quickstart
HL7v2 / ASTM E1394 interface for 1 analyzer + LIS bridge + results to Excel/PDF + audit trail. 10 days.
- HL7v2 / ASTM E1394 interface for 1 analyzer
- LIS bridge + result normalization
- Excel / PDF result export
- 21 CFR Part 11 audit trail
- 8h staff training
- 100% credit → Med Full Build within 90 days
Micro EUCAST v16 Migration Quickstart
EUCAST v16.0 (live since Jan 2026) + CLSI M100 (Ed35) breakpoints + AST interpretation grid + Expert Rules engine + SIR logic. 7 days. Your existing analyzer stays — we replace ONLY the interpretation layer.
- EUCAST v16.0 (Jan 2026) + CLSI M100 Ed35 breakpoints — full database (~3,000 entries)
- Expert Rules engine: ESBL / AmpC / CRE-Carbapenemase / MRSA / VRE / intrinsic-resistance auto-flag
- AST interpretation grid for MIC + zone diameter (manual & instrument input)
- Gepotidacin / trimethoprim / carbapenem-with-inhibitor breakpoints (v16 changes)
- SIR decision logic + AMR surveillance flags
- ML models bundled: micro.ast_predictor (85% accuracy), micro.organism_ner
- 21 CFR Part 11 audit trail
- 8h staff training (recorded)
- 30 days post-deploy support
- 100% credit → Micro Full Build within 90 days
Food HACCP CCP Quickstart
HACCP CCP monitoring + limit breach tracking + CAPA timeline + audit-ready PDF. 7 days.
- HACCP CCP real-time monitoring
- Limit breach detection + CAPA timeline
- Audit-ready PDF export
- 8h staff training
- 30 days post-deploy support
- 100% credit → Food Full Build within 90 days
Env Chain-of-Custody Quickstart
CoC workflow + 1 EPA method template (8260B/8270D/200.8) + tamper-evident timeline. 7 days.
- Chain of custody tamper-evident timeline
- 1 EPA method template (choose 8260B/8270D/200.8)
- 21 CFR Part 11 e-signatures
- 8h staff training
- 30 days post-deploy support
- 100% credit → Env Full Build within 90 days
Full Build & Deploy (one-time)
Standard
1 module · single lab · core workflows
one-time · + 20% / yr
- Timeline
- 14-21 days
- Users
- ≤ 20
- 1 module (Med, Food, Cosmetic, Micro, etc.)
- Up to 20 users
- Standard reports + 1 instrument integration
- Basic compliance templates
- 3 months post-deploy support
- 14-21 day deployment or 10% refund per week
Professional
1-2 modules · multi-site · custom workflows
one-time · + 18% / yr
- Timeline
- 21-35 days
- Users
- ≤ 50
- 1-2 modules bundled
- Up to 50 users · multi-site support
- Up to 5 instrument integrations
- Custom reports + workflow automations
- Full ISO 17025 / Part 11 templates
- 6 months post-deploy support
Enterprise
3+ modules · unlimited · enterprise governance
one-time · + 15% / yr
- Timeline
- 35-60 days
- Users
- Unlimited
- 3+ modules · full suite available
- Unlimited users + multi-tenant
- All instruments + HIS/EMR/ERP integrations
- Dedicated solution architect
- 12 months support + 24/7 P1 SLA
- Source-code escrow · $2M professional liability
Full Build payment split: 30% deposit / 40% UAT / 30% go-live · 45/55 available for expedited delivery
Managed Subscription (per user/mo)
Starter
5-10 user labs
min 5 users = $295/mo
- All modules accessible
- Standard SLA · EU/US hosting
- Daily backups · 99.5% uptime
- Email support
- 7-day full-access trial (no credit card)
Professional
10-50 users
min 10 users = $1,290/mo
- Everything in Starter
- Custom SLA · single-tenant DB
- 99.9% uptime guarantee
- Priority support · phone + email
- Ad-hoc reports builder
Enterprise
50+ users · custom
50+ users · custom
- Everything in Professional
- Dedicated infra · isolated VPC
- 99.95% uptime · 24/7 P1 SLA
- Dedicated CSM + architect
$12,900 Managed Subscription setup fee (non-refundable deposit, separate from Full Build payments) · 12-month initial commit · month-to-month after
Cosmetics premium SKUs
Blue ocean - no direct competitorCosmetic-LIMS sub-niche has no dedicated vendor combining CPNP + ISO 22716 + INCI + ICH Q1A. We charge a 30-45% premium because the gap is real - and we're still 2× cheaper than LabWare-equivalent scope.
CPNP Compliance Fast-Track
10 days · CPNP notification workflow + template library. For brands preparing EU entry.
ISO 22716 Audit-Ready Package
3 weeks · full GMP workflow + SOP templates + mock audit. For brands with upcoming retailer audits.
Stability Study Manager (add-on)
Standalone ICH Q1A/Q1B/Q1D compliance tracking. Tripwire to full Cosmetic module.
How we anchor against competitors
Verified April 2026 from public price pages and LIMS market intelligence.
All tiers include 3 months of post-deploy support, 10 training seats, IQ/OQ/PQ scripts, source-code escrow option, and SLA-backed P1/P2 response.
Prices shown here are identical to /pricing page (Paddle / Gumroad consistency).
Trust signals
Every SKU carries an explicit guarantee. You pay only if we deliver - and you keep the deployment artifacts, data, and source-code escrow if you walk away.
14-day money-back (Scoping PoC + all Managed plans)
Data never leaves your infra (on-premise)
Source-code escrow available
ISO 27001 roadmap 2026 (honest status)
$2M professional liability insurance (Enterprise)
Paddle Merchant of Record - tax compliant
Delivery guarantee: deployed in 14-21 days or 10% refund per week of delay (cap 50%).
For Quickstart SKUs: 25% refund per week of delay, cap 100%. For Scoping PoC: full refund minus deployment costs if we cannot meet your requirements. All refunds processed via Paddle within 14 days.
Why labs actually buy AssayCore
No vendor lock-in
Source-code escrow on Enterprise. On-premise default. Open API. Postgres / Keycloak / MinIO - all standard, nothing proprietary.
Compliance templates save 6-12 months
ISO 17025 QMS, 21 CFR Part 11 audit trail, ISO 22716 batch records, HACCP CCP logs - ready on day 1, not built from scratch.
Deployed in weeks, not quarters
LabWare avg 9 months (competitor). AssayCore Standard 14-21 days. Professional 21-35 days. Enterprise 35-60 days. Fixed price, no T&M.
ML out of the box
24 CPU-only models: colony detection, allergen scoring, HL7 validation, TAT forecasting. No ML team required.
Ready to scope your deployment?
$495 Discovery session (text + detailed document) · $7,995 Scoping PoC (2 weeks, 100% credit to contract).
Get in touch
Ready to scope your deployment? Try a live demo or write us - we respond within one working day.
All public demos use synthetic data. Production deploys on YOUR infrastructure with your real workflows, instruments, and SOPs.