Solutions
Smart ERP for Regulated Operations
Amorph brings the same drive for transformative solutions to how regulated companies run. Our AI-generated Smart ERP connects to every instrument and process, monitors the whole operation in real time, and keeps the business moving — with compliance built in and a qualified human approving every consequential step. It is generated for each company from its own quality system, not implemented over years.
Monitor everything, continuously
Instruments, equipment and process signals are captured and watched live — readings checked against your limits, alarms raised the moment a value goes out of range or a source goes silent.
Escalate to the right person
When a limit is breached or work stalls, the alert travels up the reporting line to the responsible manager — automatically, by your org chart.
Run the work, under human control
Orders, results and approvals flow on event cascades; the AI does the work and a qualified person approves what matters — nothing falls through the cracks.
Audit-ready by design
Every record is attributable and tamper-evident (ALCOA+), and the validation evidence regulators expect is generated as you go.
Live operations · monitored & audit-ready
One AI-run system — from the instrument to the boardroom, every signal in view and on the record.
- 21 CFR Part 11
- GxP / GAMP 5
- ISO 13485
- ALCOA+ Audit Trail
- IVDR / UDI 2026
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