Designing an Internal Data Integrity Audit Program for Pharma
In the regulated world of pharmaceuticals, data integrity isn’t just a compliance buzzword—it’s a critical requirement that underpins the quality, safety, and efficacy of every medicinal product. To proactively address regulatory expectations from agencies like USFDA or EMA, pharma companies are expected to conduct internal data integrity audits based on GMP, ALCOA+, and ICH Q9…
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