A global pharmaceutical company prioritized patient safety and regulatory compliance amid shifts to biopharma production, facing increasing complexity in quality risk management and traceability due to combined drug and medical device requirements. Previously reliant on spreadsheets and extensive process flow documents for risk assessments across hundreds of products, the company sought a more efficient solution. They turned to Sphera to reduce quality risks, streamline regulatory processes, improve traceability, and enhance overall product safety and compliance management in their evolving biopharma operations.

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