Radiopharmaceutical Therapy
12 must‑have capabilities in 2026 for a CDMO ERP selection
Based on our life sciences experience supporting outsourced operators, including contract development and manufacturing organizations (CDMO) and contract research organizations (CRO), this guide summarizes the ERP software selection requirements vendors must prove, demo, and document.
John Hannan
6 min read
Life Sciences ERP Software Selection 2026 Buyer’s Guide for validated environments (GxP‑ready)
Choosing ERP in a validated environment is different. This 2026 buyer’s guide shows how to evaluate life sciences ERP through a GxP lens—Part 11 e‑signatures, audit trails, QA release, lot/expiry traceability, and LIMS/QMS/EDMS integrations. Get selection criteria, a weighted scorecard, and five scripted demos to run with your data so your shortlist is CSV‑ready before contracts.
John Hannan
6 min read
FDA ERP Validation Checklist & Templates for 21 CFR Part 11
Learn how to validate an ERP system for FDA 21 CFR Part 11 and GxP without bloating scope. This guide shows a risk‑based path through IQ/OQ/PQ, the exact Part 11 controls to prove (e‑signatures, audit trails, timeouts, lockouts), and the evidence auditors expect for backup and restore. Includes concise test snippets you can copy and a downloadable checklist, risk traceability matrix, and test‑case template to accelerate your project. Useful for NetSuite, SAP, and D365 in regu
John Hannan
5 min read
Capacity Planning for Radiopharmaceutical Therapy - Making the Clock an Ally
Radiopharmaceutical therapy capacity isn’t just headcount and rooms—it’s physics. Activity decays by the hour; QC and licensing gates sit on the critical path; hot cells, operators and courier cut‑offs throttle throughput. This post outlines a practical playbook: anchor schedules on patient time, make bottlenecks explicit, separate strategic/tactical/operational horizons, and use finite‑capacity slotting tied to potency windows. Not a sales pitch—just a starting point you can
John Hannan
4 min read
Tracking RAM Licensing Limits - Why “Good Enough” Software Isn’t Good Enough for Radiopharmaceutical Therapy Manufacturing
Radiopharmaceutical therapy manufacturers must track radioactive material (RAM) possession in real time—by nuclide, form, location, and time—to stay within NRC/Agreement State license limits. This post shows where generic ERP fails, what purpose-built RAM tracking must do (decay math, location gates, Part 37 aggregation, 10 CFR 30.51 records), and how to evaluate software and partners.
John Hannan
6 min read
ERP and MES for Radiopharmaceutical Therapy (RPT) Manufacturing - How to Split the Work and Wire It Together Without Regret
RPT manufacturers often need both ERP and MES. This post shows how to split responsibilities—put batch truth and eBR in MES, and commercial/financial truth in ERP—then wire them with event‑based, validated integrations. Learn the boundary for labels, QA release, RAM license gates, and waste; how to avoid double entry and time‑of‑calibration drift; and what to demand in scenario‑based demos. Scale dose‑to‑door without audit risk.
John Hannan
5 min read
Comprehensive ERP Solutions for Life Sciences Companies Meeting Needs and Regulatory Requirements
Life sciences organizations, including pharmaceutical, biotechnology, and medical device companies, benefit from ERP platforms that are designed and implemented for regulated operations. The right ERP helps teams run core workflows such as purchasing, inventory, production scheduling, quality, and compliance with consistent controls, reliable traceability, and decision ready visibility.
John Hannan
5 min read
Understanding 21 CFR Part 11 Compliance when selecting a new ERP System
21 CFR Part 11 must provide complete documentation of process controls, record and data integrity safeguards, accuracy assurances, and user authentication and authorization processes.
John Hannan
4 min read
How to Accomplish FDA Validation for ERP Software
Implementing ERP software for GxP processes into an FDA-regulated business or organization requires FDA validation. The Food and Drug Administration (FDA) requires that certain technologies used in the manufacturing and storing of products, such as pharmaceuticals and medical devices, be validated before they are released to the market. Whether you are implementing Microsoft Dynamics 365 (D365) , Oracle NetSuite or another capable ERP system, the principles of FDA Validatio
John Hannan
5 min read