Reduce Quality Risk and Streamline Regulatory Processes ®2021 Sphera. All Rights Reserved. CASE S TUD Y Global Global Pharmaceutical Company Pharmaceutical 33,000+ Employees $22.3 billion Revenue OVERVIEW For one of the world’s largest pharmaceutical companies, patient safety and regulatory compliance are top priorities. Amid the evolution from conventional to biopharma drug production, this company identified an opportunity to improve quality risk management and reduce product defects. Biopharmaceutical products must meet both medical device and drug requirements, meaning compliance was growing more complex and traceability was key. But the company was using spreadsheets and massive process flow documents to conduct risk assessments for hundreds of products. The process

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