ERP Selection for Radiopharmaceutical Therapy (RPT) Manufacturers
- John Hannan
- May 15
- 4 min read
I’m writing this for teams that compound therapeutic radioisotopes, move material through hot cells, ship same-day doses, and live under Part 11, GMP, and nuclear regs. The goal: a clear, vendor-agnostic checklist for getting ERP selection right in this domain.
What makes this category different
Dose-to-door scheduling - Orders align to patient appointments and a time-of-calibration; scheduling has to respect half-life physics, time zones, carrier cutoffs, and re-labeling based on activity at ship/delivery.
Electronic Batch Record (eBR) and Part 11 - Audit trail, controlled print, reason codes, and signature workflows are not optional.
Serialized lots & genealogy - Precursor → intermediate → final dose traceability with QC results tied to specific units, enabling rapid recall.
Hazmat logistics (DOT/IATA Class 7) - Labels, docs, and proof-of-delivery events must live inside the pick/pack/ship flow.
Calibrated inventory & release gating - Activity/decay math, FEFO with decay, status controls from QMS/LIMS and equipment state from CMMS/EAM.
Waste tracking & decay-in-storage - Regulated waste movements with clocks and records that survive inspection.
Multi-site, same-day realities - Replicable processes, role-based access, and a distribution model that can scale without heroics.
Cross-functional requirements (use this as your first pass list)
Manufacturing/Compounding
Master recipes with radiation-specific UoM (mCi/MBq) and in-process activity calculations
eBR with exception handling, controlled print, and dual sign-off
Environmental monitoring flags and hold/release logic
Quality (QC/QA)
Test result capture mapped to lots/units; CoA generation
QA release workflow with audit trail and reason codes
Deviation/CAPA hooks and CSV traceability (IQ/OQ/PQ where appropriate)
Supply Chain & Inventory
FEFO adjusted for decay; expiry windows and quarantine locations
Barcode/RFID with room/suite/hot-cell segregation and geofencing
Genealogy, recall, and complaint workflows
Order-to-Cash
Patient-appointment–linked orders and daily cutoffs
Proof of delivery tied back to dose order and invoice
Contract/pricing constructs common in this space
Logistics
Embedded DOT/IATA Class 7 labels and documents at pack time
Carrier integrations aware of time zones and “activity at delivery”
Finance
Batch/lot-level costing; landed cost on regulated shipments
Revenue and charge capture that matches proof-of-delivery events
IT/CSV & Compliance
Part 11 controls, change control, and periodic review plan
Validation responsibilities defined among client/vendor/partner
EHS/Nuclear
Waste inventory, decay-in-storage clocks, and compliant recordkeeping
Analytics
On-time to calibration, dose lead-time variance, first-time-right, yield
Platform vs. partner vs. IP (why many systems can fit)
Plenty of ERPs can cover core financials, inventory, purchasing, production, and basic quality hooks. The differentiator is industry IP—accelerators such as:
Dose scheduling workbenches (half-life-aware)
Activity/decay calculators surfaced across the flow
21 CFR Part 11 Compliance through compliant functional processes
eBR frameworks with controlled print and signature workflows
Class 7 label/document packs inside pack/ship
Ready connectors to QMS/LIMS/CMMS
The implementation team matters because that’s where this IP lives. In selection, require teams to demonstrate their accelerators against your scenarios rather than describing them on slides.
How to run the selection (disciplined and vendor-agnostic)
State the outcomes and guardrails - Examples: scale to N sites, pass validation first time, reduce dose lead-time variance, budget/timeframe bands.
Interview by function - Short, structured sessions with Manufacturing, QC/QA, Supply Chain, Logistics, Finance, IT/CSV, EHS to turn SOPs into requirements.
RFP with a fit-gap grid - For each requirement, vendors answer: native, config, accelerator/third-party, or custom; include 3-year subscription and implementation estimates, and a draft CSV strategy.
Scenario-based demos (no toy examples) - Provide a dose-to-door script: order intake → batch creation → in-process controls → QC release → activity re-calc → hazmat pack/label → ship confirm → POD → invoice.
References that look like you - Multi-site, daily doses, validated environment.
Lock the SOW to what you saw - Name the accelerators, CSV deliverables, integrations, data migration scope, and cutover rehearsals.
Phasing that works
Phase 1 “dose-to-door” - Order → manufacture/QA release → ship/POD → invoice.
Parallel tracks - data cleansing, label content sign-off, integration hardening, and analytics foundations.
Later phases - advanced analytics, planning, and broader automation once the base is stable.
Validation isn’t a side quest
Treat CSV as a first-class workstream. Agree on who authors specs and test scripts, how defects are managed, and how the trace matrix maps to SOPs. Bake this into contracts; don’t leave it to “we’ll figure it out later."
Common pitfalls to avoid
Choosing by demo sizzle while skipping eBR depth
Under-scoping CSV or deferring it
Assuming master data (labels, UoM conversions, test limits) will sort itself out
Accepting “coming soon” accelerators without a production reference
SOWs that don’t explicitly include what you need on Day 1
Bottom line - Multiple ERP platforms can serve radiopharmaceutical therapy manufacturers. Success comes from pairing a solid platform with a team that brings domain accelerators—and proving that fit through a disciplined, scenario-based selection that bakes validation and logistics realities into the plan.
If this was useful, here’s an easy next step
If you’re standing up (or scaling) an RPT manufacturing program and want a neutral sounding board, I’m happy to compare notes. Send a short message via the ERPgo-live.com contact page or connect with me on LinkedIn—mention “RPT ERP selection” and I’ll share my dose-to-door demo script, fit-gap grid, and checklist you can use with your team. No pressure, just practical help.
Glossary
Radiopharmaceutical therapy (RPT), radiotherapeutic manufacturing, radioligand therapy (RLT), theranostics, PRRT, alpha (e.g., Ac-225) and beta (e.g., Lu-177) emitters, hot cells, eBR/eDHR, 21 CFR Part 11, GxP, DOT/IATA Class 7, activity at calibration, decay-in-storage, FEFO with decay, genealogy, QMS/LIMS/CMMS.
