AI operations for regulated life sciences | Call us: +1 888-835-1270 | labs@rxqmsr.com
Use Case Labs

Your operations, transformed.
One prescription at a time.

Each lab maps your current-state workflows, identifies AI agent insertion points, quantifies ROI, and delivers a phased adoption roadmap — within your regulatory guardrails. Half-day session. Prescription in 5 days.

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Lab 01
21 CFR Part 820 · ISO 13485 · QMSR 2026
QMSR Urgent
Medical Device Manufacturer
FDA's 2026 QMSR update aligns U.S. oversight with ISO 13485:2016 — your QMS is changing anyway. We embed AI agents into the refresh so the work you're doing now pays compliance dividends for years. DHR automation, CAPA intelligence, supplier risk, and document control.
DHR Assembly Agent CAPA Intelligence Agent Supplier Risk Agent Document Control Agent
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64%
Monthly QA labor reduction
62%
Faster CAPA cycle time
$18K+
Estimated monthly savings
0
Supplier escapes (target)
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Lab 02
21 CFR Part 211 · cGMP · ICH Q10
FDA Active
Pharmaceutical / Biotech
FDA just issued its first Warning Letter citing improper AI use in regulated pharmaceutical manufacturing. The message: companies remain fully responsible for AI outputs. RxQMSR designs agents built for 21 CFR Part 211 — batch records, deviations, stability, and APR.
Batch Record Intelligence Deviation Triage Agent Stability Monitor Agent APR Automation Agent
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82%
Batch review cost reduction
59%
Faster deviation closure
$40K+
Estimated monthly savings
<24h
OOT detection (was 6 weeks)
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Lab 03
21 CFR Part 111 · FTC Guidelines
Fastest ROI
Supplement / Nutraceutical
CoA backlogs eating your QA team's time. Label claims that create FTC and FDA exposure. Complaint trending that doesn't exist. These are solved problems — solvable in 30 days with agents purpose-built for 21 CFR Part 111. The fastest ROI of any life sciences vertical.
CoA Verification Agent Label Compliance Agent Batch Record Agent Complaint Intelligence Agent
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92%
CoA review time reduction
90%
Faster label review cycle
30d
Time to live pilot agent
0
Label recalls (target)
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Lab 04
Multi-scope · Parts 111, 211, 820 · ISO 13485
PE Target
Contract Manufacturer
14 active clients. 14 quality agreements. 300+ controlled documents. Multi-client operations at scale require a system — not a spreadsheet. Agents that manage your obligations, partition your documents, and keep audit readiness continuous across every client you serve.
Quality Agreement Agent Multi-Client Doc Control Audit Readiness Agent Change Notification Agent
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86%
Audit prep effort reduction
0
Quality agreement lapses
$20K+
Estimated monthly savings
0
Wrong-spec production runs

Don't see your exact scenario?

Every client's current state is different. Book a discovery call and we'll map your specific workflows before the lab session.

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