Understanding Quality Management Systems in Life Sciences A Quality Management System (QMS) is the backbone of regulatory compliance for pharmaceutical, biotechnology, and medical device companies.
What Are Mock FDA Inspections? Mock FDA inspections are simulated regulatory audits designed to prepare pharmaceutical, biotechnology, and medical device companies for actual FDA inspections.
Understanding FDA 483 Observations When the U.S. Food and Drug Administration (FDA) inspects pharmaceutical, biotechnology, or medical device facilities, the inspector may issue a Form
Understanding Data Integrity in Life Sciences Data integrity is a critical component of FDA compliance in the pharmaceutical, biotechnology, and medical device industries. It ensures