BowTieXP Suite helps pharmaceutical organizations manage operational, quality, and compliance risks ensuring patient safety, product integrity, and regulatory alignment across the value chain.
In the pharmaceutical industry, every process from R&D to distribution carries risks that can affect patient safety, product quality, or compliance. BowTieXP Suite enables a clear, visual understanding of these risks by linking hazards, controls, and consequences. BowTieXP Suite also supports quality risk management (QRM) by integrating data from audits, deviations, and CAPAs into a single framework. This helps organizations move beyond reactive compliance toward continuous improvement, aligning with ICH Q9, GxP, ISO 9001, and FDA expectations for risk-based decision-making.
