COMPLIANCE ENGINE FOR 503A PHARMACIES

Continuous compliance monitoring for every lot you compound

Archon monitors your operation against state board rules, federal requirements and your SOPs as the work happens. Problems are caught and fixed at the stage where they start, instead of turning up at release.

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LOT 26-0417Sterile injectable · 240 units · ships to 41 states
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STATE REQUIREMENTS

Checked against the rules of every state you ship to

Every state board sets its own requirements, from staff and facilities to labeling and shipping. Archon tracks each board's changes and checks every lot against the latest rules for every state it ships to, so an update you missed can't get through.

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BOARD CHANGES · LIVE
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COMPLIANCE ENGINE

Your requirements, turned into checks the system can run

Each requirement from state boards, federal law and your SOPs becomes a formal rule. Archon evaluates your records against those rules deterministically, so the same evidence always gives the same result. Generative AI never makes a release decision.
REQUIREMENTS
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ENCODING
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ARCHONEngine{{ evalCount }} checks / min
YOUR EVIDENCE
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Every result is linked to the data and records behind it

Each check shows the rule it applied, the exact data it used, and the source record it came from, with IDs and timestamps. The audit trail is kept automatically.

RULEDATA CHECKEDSOURCE RECORD
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3 MATCHED1 ADVISORY4 rules · 4 data points · 4 source records, all saved to the lot file.
AGENTS

Agents fix problems as they come up

Agents watch every stage while work is in progress. When something falls out of compliance, they explain what's wrong, assign it to the right person, and track the fix, so it's resolved before the lot reaches release. Your pharmacist still makes the final decision.

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Surface sample over action levelHOOD B-2 · LOT 26-0417 · 8:14 AM
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WHY
RULESOP-207 §3
RESULT4 CFU
ACTION LEVEL> 3 CFU
Caught during QC, before release. An excursion needs an investigation, corrective action, and identification of the organism. The lot stays at this stage until that's done.
JP
Assigned to J. Patel, Designated PersonCleanroom lead and QA notified
ROUTED
REMEDIATION PLAN
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Built by AI and software engineers with a board-certified sterile compounding pharmacist

NB
Nihaal BhojwaniCO-FOUNDER · TRUSTWORTHY AI

AI researcher who previously led work at NASA Ames, Lockheed Martin AI and Caltech. His first-author work was highlighted at NeurIPS AI for Science 2025.

SK
Saumit KaleCO-FOUNDER · SCALABLE SOFTWARE

Built mission-critical software at Citi, AWS and Varda Space, including a rules engine serving 130 countries.

AS
Amy Summers, PharmD, BCSCPADVISOR · PHARMACY COMPLIANCE

Among the first Board Certified Sterile Compounding Pharmacists. Former PIC, Director of Operations, and Managing Director of a 503B facility.

See how Archon works with your records

In a 30-minute call, we'll walk through how Archon would work with your SOPs and the states you ship to.

Book a demo