Quality is a universal principle, and this volume delivers essential tools for maintaining Quality Systems & Compliance, as defined by ICHQ10. Targeted for pharmaceutical companies, it introduces the critical framework, The Health of the Quality Management System (QMS).
Key elements include:
Corrective Action Preventive Action (CAPA)
Deviation Management & Trending
Root Cause Analysis
Internal Audits & Inspections
Quality Risk Management (QRM)
Quality Management Review
When executed in compliance with regulations and internal standards, these programs ensure a Healthy QMS—one that drives continuous improvement while maintaining process suitability and capability.
Whether in pharmaceuticals or beyond, this volume offers a structured, actionable approach to achieving quality excellence across industries.