Quality Management Systems

ENSURE BUILT-IN QUALITY

Having a proper Quality Management System (QMS) in place cannot be overstated. QMS’s formalized processes, records, policies, and procedures ensure quality is built into products, that products are safe, perform as intended, and meet regulatory standards. QMS encompasses processes such as GxP, Change Control, Corrective/Preventative Actions, and Management of Risk, Documents, Suppliers, Training, Deviation, and Audit.

QMS should be implemented as early as possible in the Drug Development Lifecycle – design/discovery phase, preclinical phase, clinical phase, and regulatory/market approval. Proactively implementing a QMS early ensures systems are in place to address any quality issues during the product life cycle and ensures products are designed to meet regulations and standards. The processes and procedures entailed maintain a state of control throughout the product development life cycle.