All Posts
ERP selection and validation in FDA‑regulated companies (CSV & 21 CFR Part 11)
Most teams treat validation after vendor choice—backwards. This guide shows how to bake CSV and 21 CFR Part 11 into ERP selection: translate URS into measurable criteria, compare vendors on audit trails, e‑signatures, and role security, and outline a pragmatic VMP with risk‑based IQ/OQ/PQ. The goal is selection that stands up in audit and in operations—no bolt‑on validation scramble later.
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
A Practical ERP Software Selection Playbook for Confident, Defensible Decisions
Software selection becomes risky when decisions hinge on demos instead of evidence. This guide shows how to structure selection with clear criteria, weighted scorecards, scripted day-in-the-life demos, integration and data checks, and TCO analysis. Built from 25+ years of running selections across manufacturing, distribution, and life sciences, it’s a vendor-neutral playbook for confident and defensible decisions that hold up on go-live day.
John Hannan
7 min read
Distribution ERP Selection - A Playbook for Real‑World Distributors
Choosing a distribution ERP means testing real workflows—pricing, rebates, transfers, WMS/TMS, drop-ship, EDI—not just features. This playbook walks distributors through process-based evaluation, weighted scorecards, data migration pitfalls, demo scripts, and KPIs that expose the real differences between platforms. A practical guide for multi-branch and value-add distributors selecting their next ERP.
John Hannan
5 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
Why Outsourcing the “Internal” ERP Project Manager Often Saves the Program
ERP projects rarely fail because the software doesn’t work—they fail because no one owns the whole picture. When multiple vendors, ISVs, and integration partners are involved, coordination gaps multiply. An outsourced internal ERP project manager acts as the owner’s representative, bridging systems, timelines, and decisions across teams. This post explores why neutrality, structure, and focus often make the difference between drift and delivery.
John Hannan
4 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 Selection for Make-to-Order manufacturers - What actually matters
As a make-to-order leader, you can’t buy ERP by brochure. I outline the essentials I test in every selection: a clean CPQ→ERP handshake that explodes a manufacturable variant BOM/routing, revision control and ECOs from CAD/PLM, finite capacity scheduling, long-lead pegging, real job costing, and quality/traceability. Many systems fit; the right partner with industry IP and a scripted, hands-on selection makes the difference.
John Hannan
4 min read
Choosing an ERP Implementation Partner for Distribution
ERP software fit is only part of the decision. Industrial distributors should also evaluate whether the implementation partner can prove its experience with pricing, rebates, WMS, EDI, branch operations, data migration, testing, and go-live readiness.
John Hannan
5 min read
ERP Selection Considerations for a Contract Development and Manufacturing Organization (CDMO)
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.
John Hannan
4 min read
ERP Selection for Radiopharmaceutical Therapy (RPT) Manufacturers
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.
John Hannan
4 min read