Implementation Advisory
10 ERP Software Selection Risks Leaders Should Never Ignore
ERP implementation failures are often blamed on poor training, weak adoption, or implementation execution. In reality, many ERP problems begin much earlier during software selection and generally do not usually appear at once. They tend to build throughout the process, starting with incomplete requirements, limited stakeholder involvement, and weak operational understanding. Those early gaps then influence vendor demonstrations, scoring, implementation planning, cost assumpti
John Hannan
10 min read
Risks to Watch in your ERP Mobilization Plan and Delivery
Project mobilization is the phase between contract signing and execution where ERP outcomes are decided. This guide breaks down the mobilization actions that reduce go-live risk across program governance, data migration, testing, cutover, hypercare, and change adoption, plus a practical checklist to keep teams aligned and accountable.
John Hannan
6 min read
ERP software selection and implementation challenges for growing manufacturers and distributors
Growing manufacturers and distributors often discover that ERP risk is created long before go-live. This article breaks down the most common failure points in ERP software selection and implementation and explains how leaders can pressure-test assumptions, protect scope, and build a system foundation that supports scalable operations.
John Hannan
4 min read
ERP selection for mid‑market manufacturers (200–1,000 employees): how to make a defensible shortlist and lead it to go‑live
If you run a 200–1,000‑person manufacturing company, this guide shows how to pick a defensible ERP: capture requirements, issue an RFP, score vendors with an objective fit/gap model, and run conference‑room‑pilot demos. We cover PLM/MES/QMS integration, multi‑site inventory, serial/lot traceability, PPAP/APQP, and MRP—so you can phase the rollout without disrupting production. Vendor‑neutral, practical, and built from real selections and client‑side implementations.
John Hannan
5 min read
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
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
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
Identifying Business Requirements for a Life Sciences ERP Implementation
One of the most important pieces of selecting and implementing an ERP system at a life sciences company is the identification of the busines
John Hannan
2 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
Implementing MPS in a live ERP for contract manufacturers (the phase-2 playbook I actually use)
For contract manufacturers, MPS is a phase-2 project that turns OEM forecasts, long-lead metals, and outside processing into one weekly, believable plan. I lead your team to evaluate native ERP MPS, wire forecast consumption, time fences, RCCP/finite constraints, subcontract ops, and long-lead pegging. If native planning won’t bend, we prove and implement a third-party engine—same cadence, measurable OTTP and stability gains.
John Hannan
6 min read
ERP Customization vs. Configuration: Finding the Balance for Your Solution
Finding the ideal balance between customization and configuration in the ever-changing world of enterprise software is comparable to...
John Hannan
4 min read
Enhancing Manufacturing Efficiency with ERP Solutions
Achieving efficiency is essential in the fast-paced manufacturing environment of today. Businesses are turning to Enterprise Resource...
John Hannan
3 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
ERP Stakeholders and Their Role in Software Selection and Implementation
ERP touches the core of the business. When stakeholder input is too narrow, companies often select systems based on polished demonstrations, executive preference, vendor familiarity, or incomplete requirements.
John Hannan
9 min read
The Importance of Selecting A Trusted ERP Implementation Partner
When it comes to implementing Enterprise Resource Planning (ERP) software systems, it can prove quite a burden for some firms. That is...
John Hannan
3 min read
Aligning ERP Design to Drug Supply Chain Security Act (DSCSA) Serialization and Traceability
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.
John Hannan
4 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
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.
John Hannan
5 min read
Is Your ERP Implementation Experiencing Delays? The Common Causes and How To Avoid Them.
Are you finding that your ERP implementation plan is taking longer than expected? Delays are common in ERP implementations, and...
John Hannan
6 min read