ERP SELECTION INSIGHT AND BEST PRACTICES

A new radiopharmaceutical manufacturer with plants under construction needed a system of record before the first batch. The selection led straight into a multi-year implementation role.

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.

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.

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. A checklist, risk traceability matrix and test-case template are available on request.

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

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.

Selecting ERP for a CDMO requires proof, not promises. Use these CDMO demo tests and implementation watch outs to choose a platform that holds up in execution, audit, and program profitability.

Practical ERP selection checklist for radiopharmaceutical therapy (radiotherapeutic/radioligand) manufacturers. Covers dose-to-door flow, eBR/Part 11, genealogy, decay-aware inventory, Class 7 shipping, and validation.

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.

The Drug Supply Chain Security Act (DSCSA) is pushing the industry toward an interoperable, electronic way to identify and trace certain prescription drugs at the package level as they move through the supply chain.

21 CFR Part 11 must provide complete documentation of process controls, record and data integrity safeguards, accuracy assurances, and user authentication and authorization processes.

Validation is proving that a system meets the intended purpose it was designed for by confirming that the system works properly. Validating an ERP system involves testing and validating its various components, including security controls, configuration settings, processes, functions, and reports.

Recall readiness is not a single feature. It is the ability to detect an issue, contain it quickly, and prove what happened with an audit ready trail.

A CRO sells a service, not a product, so its ERP needs differ: project accounting, milestone invoicing, prepayments and deferred revenue, and time tracking.