ERP SELECTION INSIGHT AND BEST PRACTICES

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.

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.

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.

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.

21 CFR Part 11 must provide complete documentation of process controls, record and data integrity safeguards, accuracy assurances, and user authentication and authorization processes.

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.