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Fagron Case Study

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How do you get quality experts around the world on the same page? With 49 global locations—from Kansas to Krakow— Fagron needed a way to ensure each facility could consistently produce pharmaceuticals that meet the company's lofty quality standards. Fagron's worldwide footprint comes with a few challenges. The trickiest one might be staying in compliance with the regulations of every market they serve. The FDA in the United States has slightly different rules than ANVISA in Brazil. And those differ from the European Commission in the European Union. In fact, for each of the seventeen countries within the EU, there are seventeen different regulators that need to be accounted for and validated. All that variability led to inconsistent processes. The teams at each Fagron location had their own standard operating procedures. Even common processes had issues. Teams would use Word documents to update work instructions, often leading to confusion about which document was the most recent – and the most accurate. Required training used a cumbersome manual process as well. Quality management teams would print up to 300 pages of training materials every week. It would take nearly 9 hours to print, bind, and place the large binders in an autoclave to sterilize them so they were able to be used in the laboratory and manufacturing clean rooms. MasterControl Case Study: Fagron 1 Case Study Company Overview Focus: Pharmaceutical compounding Countries: 22 Locations: 49 Employees: 2747 Quality Professionals: 330

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