Pharma
CDMO ERP selection - 12 must‑have capabilities for 2026
CDMOs can’t buy ERP like generic process manufacturers. This guide turns 12 must‑have capabilities into a defensible selection: lot genealogy with retained samples, QC sampling and LIMS hand‑off, MRB/quarantine, client‑owned material and pass‑through fees, UDI/eDHR and controlled labeling, stability/EM, equipment gating, and Part 11 with validation accelerators. Use our vendor‑neutral RFP, scripted demos, 1/2/3/4/U scoring, and PRICEFW log to align stakeholders and avoid scop
John Hannan
4 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
4 min read
Life sciences ERP software selection - 2026 buyer’s guide (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
4 min read
FDA ERP Validation (21 CFR Part 11): Practical Checklist & Templates
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
ERP Selection Considerations for a Contract Development and Manufacturing Organization (CDMO)
Choosing ERP for a CDMO is more than features—it’s compliance and project fit. Prioritize cGMP/21 CFR Part 11 controls, ASC 606 project accounting and WBS, sponsor visibility via portals, and integrations to LIMS, MES, and 3PL. Use these points to script demos, compare vendors, and run a realistic pilot so you can select, validate, and implement with less risk and faster time to value.
John Hannan
3 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
Unleashing the Power of Data: ERP's Role in Business Intelligence for Life Sciences
In the complex and quickly changing world of life sciences, data is a significant component, a vital piece in the scheme of things as far as Life Sciences are concerned. Evidently, the industry advances as a result of the boost it provides for research, development, and innovation. The key to advancement is the ability to efficiently harness, analyze, and derive useful insights from huge volumes of data. Now, this is where ERP comes in. The Importance of ERP to Life Science
John Hannan
4 min read
Comprehensive ERP Solutions for Life Sciences Companies - Meeting Needs and Regulatory Requirements
Life sciences companies face a different ERP reality: it’s not enough to manage inventory and finance—you also have to prove control to regulators every day. This article explores how comprehensive ERP solutions support GxP processes, 21 CFR Part 11, quality, and supply chain traceability while still enabling growth, better data, and smoother collaboration across QA, operations, and finance.
John Hannan
4 min read
Aligning your ERP Design for Drug Supply Chain Security Act (DSCSA) Compliance
Passed by the US Congress in 2013, the Drug Supply Chain Security Act (DSCSA) was intended to promote a safer and more reliable drug...
John Hannan
4 min read
Where does ERP Implementation Fit into a Pharmaceuticals Drug Pipeline?
When considering the pharmaceuticals drug pipeline, it's easy to focus on product development, clinical trials, and getting FDA approval;...
John Hannan
3 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...
John Hannan
5 min read
How ERP Helps Life Sciences Firms Avoid Recall & Improve Product Quality
For life sciences firms, product safety, and quality are paramount. A product recall can be costly and damaging to a firm's reputation....
John Hannan
2 min read
How ERP Systems Are Changing Pharmaceutical Companies
Technological advancements have revolutionized how modern companies operate. Current and future innovations continuously shape how...
John Hannan
3 min read
Top 10 ERP Software Functions for Life Sciences
ERP can be beneficial to the life sciences industry - from serial number traceability to compliance and more.
John Hannan
3 min read
Why Pharmaceutical Companies Need ERP Manufacturing Software
Find out the benefits of using ERP Manufacturing Software in the Pharmaceutical Industry
John Hannan
2 min read
What's different for a Contract Research Organization (CRO) when implementing an ERP solution?
The segment of industry known collectively as Contract Research Organizations (CROs) has a unique set of requirements as the primary revenue
John Hannan
3 min read
What does the Drug Supply Chain Security Act (DSCSA) mean for Life Sciences ERP Implementations?
The world of regulatory and compliance is ever evolving as both the demand for controls and the ability of technology to provide them impact
John Hannan
2 min read
FDA Validation on a Microsoft Dynamics 365 Life Sciences Project - Impact of IQs, OQs, and PQs
The Microsoft Dynamics 365 ERP will be supporting processes that fall within FDA Good Practices (GxP) guidelines, the most prevalent being G
John Hannan
3 min read
The Software Selection Process for a Life Sciences ERP Implementation
Selecting a software vendor to provide the new ERP solution for a pharmaceutical or medical device company is a detailed process that has an
John Hannan
2 min read