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.

Capacity planning for radiopharmaceutical therapy - plan around decay, QC gates, hot cells and courier cut-offs so every dose releases on time.

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.

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.

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.