ARTWORK COMPLIANCE AUDIT How Robust Artwork Operations Withstood Regulatory Scrutiny

This case study highlights how a global pharmaceutical company successfully navigated regulatory inspection scrutiny of its artwork operations. During a European Health Authority inspection, historical artwork changes related to safety updates, barcode modifications, and market expansions were reviewed. With Freyr as its artwork operations partner, the organization demonstrated strong traceability, controlled approvals, disciplined version management, and robust vendor governance—resulting in zero artwork or labeling observations and positive inspector feedback.

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