Medical device manufacturing demands traceability — ERP can't simulate the validation path.
Cleanroom assembly, sterilization holds, and validation gates create ripples ERP never models. RippleFlo traces every lot from PO to release with audit-grade replay.
Tracks lots. Can't model validation chains.
Medical device manufacturing requires validated processes, sterilization holds, and QC gates. ERP schedules operations — it doesn't simulate how a sterilization delay ripples to release.
- Sterilization holds applied as fixed offsets
- Cannot model cleanroom capacity and queue contention
- Validation review triggered at release — not proactively
- CAPA-style schedule changes lack pre-commit evidence
Simulates the validated path.
Component prep through cleanroom, assembly, sterilization, validation QC, and release — with pegging trees and deterministic replay for quality review.
- Sterilization hold and cleanroom queue modeling
- Validation gate risk scoring before release review
- Pegging tree from PO → lot → operation → root cause
- CAPA-style pre-commit blast preview
Medical device manufacturing — ERP vs RippleFlo
| Dimension | ERP / MES | RippleFlo |
|---|---|---|
| Release scheduling | Fixed validation lead time | DES with hold & gate modeling |
| Sterilization | Static hold offset | Dynamic hold chain ripples |
| Cleanroom capacity | Assumes available | Queue contention simulated |
| Validation risk | Found at sign-off | Amber/red scoring earlier |
| Lot traceability | Batch record lookup | Live pegging tree + archive |
| Equipment failure | Post-event log | MTBF/MTTR in simulation |
| Audit trail | Manual reconstruction | Deterministic replay + diff |
| What-if cost | Change live lot | Re-run model — zero risk |
Watch a medical device lot ripple through validation.
Assembly queues. Sterilization extends. Release review turns amber — before the CAPA meeting.
How RippleFlo solves what ERP cannot in medical devices.
Validated manufacturing paths need simulation-backed schedule evidence.
Validation risk scoring
Flag lots at risk before release review — planning and quality see the same alert.
Sterilization hold chains
Trace how hold extensions ripple through labeling and release.
CAPA-ready preview
Pre-commit blast shows which lots shift before QA signs off.
Pegging tree export
PO → lot → operation → root cause for quality and regulatory review.
Alternate validated routes
Route through qualified alternates when primary line is down.
Deterministic replay
Re-run any historical lot scenario with identical inputs.
Sterilization extended 8 hours. Four lots. Four different release paths.
ERP shifts all lots equally. RippleFlo measures slip per lot against its validation window — MD-04 slips 1 day while MD-01 clears QC before the hold peaked.
- Per-lot slip with attribution (% sterilization vs assembly queue)
- Stage-to-stage trace through validation gates
- Pre-commit preview before QA release sign-off