The Digital Nervous System for 503B Compounding
Eliminate paper sheets, prevent transcription deviations, and maintain an audit-ready facility in real-time. Purpose-built for FDA-registered outsourcing facilities.
0%
Transcription Errors
< 4 Hours
QA Batch Turnaround
100%
Part 11 Compliant
USP <797>/<800>
Sterile Alignment
One Unified Platform. Two Specialized Interfaces.
Compounding technicians execute sterile operations via the glove-friendly iPad client, while quality and operations command the facility from the Next.js web dashboard.
Compounding Sequence
Pre-compounding Clearance
Completed by Tech M. Jones
Active Ingredient Verification
Current Active Step
Vortex & pH Validation
Locked step
Scan Ingredient Barcode
Compounding requires physical barcode verification of Lot & Expiry to prevent wrong-constituent errors.
Product Capabilities
Compliance-Gated Compound Operations
Generic platforms make you retrofit paper processes. Clarix was engineered specifically for FDA 503B operations, embedding cGMP rules and USP guidelines into the code itself.
Digital Batch Records
Build cleanroom MBRs with exact ingredient parameters, steps, and required co-signatures. Force step-by-step completion to eliminate retrospective batch data logging entirely.
- Guided execution loops for technicians
- Real-time weight and measurement validation
- Dynamic USP <797> beyond-use date calculator
Cleanroom QMS
Prevent non-conformances with out-of-specification (OOS) blocks. Automatically spawn deviations directly from cleanroom events and manage linked corrective actions (CAPA).
- Auto-deviation triggers on parameter failures
- Review-by-Exception QA release queue
- Investigation drafter using structured logs
Environmental Monitoring
Schedule, sample, and map colony-forming units (CFUs) across ISO 5/7/8 rooms. Ensure active sample incubation timers and link excursions directly to affected production batches.
- Visual cleanroom sampling room-maps
- Automatic viable & non-viable particle alerts
- Excursion trace-back to affected batch logs
FIFO Lot Inventory
Perform barcode receiving and lock down supply inputs into strict Quarantine-to-Release states. Enforce strict First-In, First-Out material flows and track full vendor parameters.
- Dynamic stockout and expiry forecasting
- Glove-friendly barcode scanner lot-receiving
- Chemical master & allergen segregation logs
Equipment & Calibration
Lock down autoclaves, scales, and biological safety cabinets to Qualified States. Prevent batch execution with out-of-calibration or uncleaned cleanroom hardware.
- Automated calibration date schedules & reminders
- Sanitizing agent rotation & room cleaning logs
- Direct balance wedge-weight integration
Audit & Trust Posture
Built to Survive Your Next FDA 483 Inspection
In compounding, compliance is not an afterthought — it is your license to operate. Clarix embeds 21 CFR Part 11 validation and cGMP enforcement into every core database action and touch interface.
Dual E-Signatures (§ 11.50)
Capture signer name, timestamp, and meaning (such as approval, check, or release) on all critical batch actions.
Immutable Audit Trail (§ 11.10)
UUID v7 time-sortable database records. Secure, computer-generated, timestamped audits track all modifications automatically.
Turnkey Validation Package
Complete IQ/OQ/PQ protocols matching the Clarix source code version, cutting validation time from months to days.
Operator: Priya, D. (PIC) · IP: 10.12.92.14 · Session Token: b6a8...21
"entity": "batch",
"entityId": "BATCH-FENT-797-12A",
"orgId": "facility_orlando_01",
"action": "STATUS_CHANGE",
"changes": { "from": "review", "to": "released" },
"coSigners": ["Tech M. Jones", "PIC D. Priya"]
}
Operator: Jones, M. (Technician) · IP: 10.12.94.88 (iPad #03)
>> e-signature PIN matches hash. Validated constituent lot LOT2026-F983A.
Operator: Clerk, K. (Warehouse) · IP: 10.12.94.102 (iPad #07)
>> Lot received: Quarantined state enforced. Label printed with barcode barcode_983ac2.
Industry Benchmark
How Clarix Outperforms the Alternatives
Paper-based records are highly susceptible to critical transcription errors. Legacy MES systems are built for massive industrial manufacturing, not small-batch compounding. Clarix bridges the gap.
| Parameter | Paper & Excel Records | Legacy Enterprise MES | Clarix Platform |
|---|---|---|---|
| QA Release Turnaround | 10 to 14 days (Manual record auditing) | 3 to 5 days (Clunky system workflows) | Real-time (Review-by-Exception system) |
| Cleanroom Verification | Manual visual verification (Error-prone) | Keyboard-based lot number typing | Glove-friendly iPad barcode scan matching |
| Environmental Excursion Tracing | Days of manual log sheet auditing | Complex database query matching | Immediate auto-linking of batch-to-room |
| E-Signature Posture | Incomplete/Missing signatures (High 483 risk) | Basic password prompt popup | Dual PIN co-signatures with strict role gates |
| Beyond Use Date (BUD) | Manual lookup sheets (Calculated by hand) | Fixed value database templates | Dynamic USP <797> rules calculations |
| Hardware Qualifications | Manual check of paper calibration folders | Overdue state warning banner | Hard blockout of out-of-cal scales |
Is paper holding back your operations? We offer free paper-to-eQMS data migration services during onboarding.
Early Bird — 20% Off for First 5 Clients
Applies to installation fee, subscription, and lifetime access. Limited slots remaining.
Pricing
Transparent pricing for every stage
All plans include a one-time $10,000 installation and unlimited users within your organization. No hidden fees, no per-seat surprises after onboarding.
$399/mo
$4,788/yr recurring
Up to 5 users · 1 facility
Validate Clarix in your facility before full deployment. Ideal for quality teams evaluating digital batch records.
- Digital batch records (up to 100/mo)
- Environmental monitoring module
- 21 CFR Part 11 audit trail
- Role-based access control
- iPad batch execution app
- Email + Slack notifications
- Implementation support included
$899/mo
$10,788/yr recurring
Unlimited users · 1 facility
Full production deployment for a single 503B facility. Covers all core modules and compliance workflows.
- Everything in Pilot
- Unlimited batch records
- Unlimited users within organization
- FIFO lot inventory & traceability
- Equipment calibration & PM
- CAPA & deviation workflows
- e-Signature (21 CFR Part 11)
- SOC 2 Type II data residency
- Dedicated Customer Success Manager
From $1,999/mo
From $1,999/mo/facility recurring
Multi-site · custom SLA
For FDA-registered outsourcing facilities operating at scale. Full platform with white-glove onboarding.
- Everything in Growth
- Multi-facility management
- Custom HL7 / API integrations
- On-premise or private cloud deploy
- IQ/OQ/PQ validation package
- Custom SLA + 24/7 support
- Executive QA business reviews
Includes validation documentation for FDA inspections.
Contact Sales$100,000
platform licenseOne-time investment for permanent platform access. Pay once, use forever — all future feature updates and compliance modules are included at no additional charge. Operational costs (hosting, infrastructure, third-party services) are billed separately at cost.
Break-even vs. Growth subscription
At $10,788/yr (Growth annual), Clarix Lifetime breaks even in ~10 years — then your software costs nothing, forever. With early bird pricing ($88,000), break-even drops to under 9 years.
Everything included
- Everything in Enterprise
- Unlimited users within organization
- All future software updates & modules
- No recurring license fees — ever
- IQ/OQ/PQ validation package
- Dedicated lifetime account team
- On-premise or private cloud deploy
- Custom SLA + 24/7 priority support
Early Bird: $88,000 total
First 5 clients pay $88,000 instead of $110,000 — saving $22,000. Contact sales to claim your slot.
Feature Comparison
What's included in each plan
Every plan shares the same core compliance infrastructure — differences are in scale, modules, and support.
Pilot
Growth
Enterprise
Batch Records
Quality & Compliance
Environmental Monitoring
Inventory & Traceability
Equipment
Training
Lab
Users & Access
Integrations & Infrastructure
Support & Onboarding
Not Sure Which Plan?
Estimate your cost
Dial in your facility's user count, batch volume, and site count — we'll recommend a plan and show how it stacks up against competitors.
Pricing Calculator
Estimate your Clarix cost
Drag the sliders to match your facility — price updates live with each change.
Apply Early Bird Discount (20% off)
First 5 clients only — applies to installation + subscription or lifetime
13 total users · 200 batches/mo · 1 facility
Recommended
Growth Plan
$899/mo
$10,788/yr + $10,000 installation
Annual Cost vs Competitors
Competitor estimates from published/reported pricing for 13 users (May 2026). Only competitors with higher annual cost shown. Actual quotes may vary.
~$150,087/yr in recoverable QA labor
Estimated labor waste on manual transcription and QA batch review, minus your Clarix subscription.
Included on every plan
All plans include a $10,000 one-time installation fee. Annual pricing billed as a single payment. Monthly billing available at a small premium. No long-term contracts required on Pilot and Growth. Enterprise and Lifetime terms are negotiable. First 5 clients receive 20% off all fees.
Join the Pilot
Request Your Sandbox Environment
We are currently accepting a limited cohort of 503B compounding facilities into our Pilot Partner Program.
Compliance Guarantee: If Clarix does not pass your system validation requirements, we'll refund onboarding fees in full.
Concierge Setup: We digitize your first five master formulas and component records for free.