Case Study: Fresenius Kabi achieves improved CA/PA and document management with Ideagen's Q-Pulse

Fresenius Kabi benefit from improved CA/PA and document management

Fresenius Kabi’s FK Halden site, a pharmaceutical manufacturing arm based near Oslo, faced rising regulatory and customer demands (ISO, cGMP, FDA and extensive contract manufacturing) while relying on paper-based quality systems. Those manual processes made corrective and preventive action (CA/PA) management, document control and audit readiness increasingly difficult to maintain.

The company implemented Ideagen’s Q‑Pulse electronic quality management solution, replacing paper workflows to centralize CA/PA, document versioning and action escalation. The system improved visibility and audit readiness, reduced paper use, prevented process bypasses, and saved the Quality Coordinator about one hour per day while enabling the firm to demonstrate compliance “on demand.”

Fresenius Kabi

Erik Paulsen

Quality Coordinator