12 must‑have capabilities in 2026 for a CDMO ERP selection
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.
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
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
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
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
Managing the ASC 606 Revenue Recognition Standard in ERP Systems
ASC 606 isn’t a switch—it’s ERP design. This guide turns the 5‑step model into contracts, performance obligations, SSP allocation, events, and schedules you can audit. See how to handle variable consideration, acceptance, and contract changes, then build disclosures that tie to the GL. Includes high‑level pointers for D365, NetSuite, Infor, Epicor, Acumatica, and IFS, plus a checklist to test edge cases before go‑live.
John Hannan
4 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 Administration (FDA) requires that certain technologies used in the manufacturing and storing of products, such as pharmaceuticals and medical devices, be validated before they are released to the market. Whether you are implementing Microsoft Dynamics 365 (D365) , Oracle NetSuite or another capable ERP system, the principles of FDA Validatio
John Hannan
5 min read