Pharma & GxP
340B Compliance Controls for Pharma SAP Environments
2026-04-16 · 6 min read
340B pricing compliance requires automated order-to-cash controls, audit evidence, and GxP-aligned access governance — not spreadsheet attestation before inspection.
Why 340B is an access and process control problem
340B program integrity depends on who can change pricing, customer master data, and billing conditions in SAP — not just on periodic sample testing. Segregation of duties and O2C control automation provide continuous evidence.
Automated O2C evaluators for 340B
AI Tech Secure includes a dedicated 340B pricing compliance evaluator within the 22 O2C automated controls. Runs produce findings, remediation workflows, and GxP audit pack exports suitable for FDA and internal audit review.