News filtered by category

Data integrity failures can create consequences far beyond the quality department. This white paper examines FDA enforcement trends, common data integrity gaps, audit trail review, computerized system controls, and practical steps pharmaceutical and biologics manufacturers can take to strengthen data governance and reduce compliance risk.

Supplier oversight is becoming increasingly complex for pharmaceutical, biotechnology, and other FDA-regulated organizations that rely on contract manufacturers, laboratories, and critical suppliers. Traditional supplier quality management practices, including periodic audits and questionnaires, may leave significant gaps between formal reviews as regulatory status, performance, and data integrity risks change.

FDA inspection readiness cannot be treated as a short-term preparation exercise before an expected inspection. For pharmaceutical, biotechnology, and medical device organizations, maintaining continuous inspection readiness means building a quality system that produces evidence of compliance during everyday operations, not just when an inspection is approaching.

An effective corrective and preventive action (CAPA) program should do more than document that an issue was addressed. It should demonstrate that the root cause was identified, the appropriate corrective action was implemented, and the fix actually worked. As regulatory scrutiny increases, organizations need CAPA processes built around evidence, meaningful effectiveness checks, and investigations that can withstand inspection.