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Vendor Sheet

Good Manufacturing Practice

Good Manufacturing Practice

IQVIA
Pages 4 Pages

This fact sheet addresses rising data integrity issues in pharma manufacturing. Citing FDA warning letters, it identifies root causes like poor systems control, inadequate audit trails, training gaps, and weak corporate culture. It recommends a compliance maturity model and structured approaches for remediation: strong QMS, leadership commitment, proactive audits, and fostering a culture of quality. IQVIA emphasizes prevention over remediation, highlighting the heavy costs of non-compliance and the importance of continuous improvement.

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