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Is the Absence of Data Integrity Software Affecting the Assurance of Gel Clot Assays in Bacterial Endotoxin Testing?

Data integrity remains an important topic in pharmaceutical and biopharmaceutical manufacturing science. The purpose of data integrity is to ensure that the accurate process of production and quality of the products are shown through the documentation that is associated with them. It is essential that facilities report what is occurring in their labs’ processes to ensure that good laboratory ethics are continuously practised throughout the production of their products. Although this is nothing new to the community, LaToya Mayfield at FUJIFILM Wako Chemicals U.S.A. Corporation states that every manufacturer around the world must ensure that the data related to their products has not been affected or compromised.

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