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
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
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