Resource Library
Overcoming Data Integrity Challenges In Biopharmaceutical Production
To ensure the safety and efficacy of pharmaceutical products, the FDA and other regulatory agencies require a high level of data integrity (DI) in the manufacturing process. In this whitepaper, Calvin Kim, our Head of IT Quality Systems and Validation, discusses various controls required to tackle DI-related challenges and to create a holistic framework of data-driven governance. As a CDMO service provider, Samsung Biologics strives to set an industry-leading standard in DI practices, supported by innovative technology, conscientious corporate policy, and efficient quality systems for consistent delivery of products and services.
To ensure the safety and efficacy of pharmaceutical products, the FDA and other regulatory agencies require a high level of data integrity (DI) in the manufacturing process. In this whitepaper, Calvin Kim, our Head of IT Quality Systems and Validation, discusses various controls required to tackle DI-related challenges and to create a holistic framework of data-driven governance. As a CDMO service provider, Samsung Biologics strives to set an industry-leading standard in DI practices, supported by innovative technology, conscientious corporate policy, and efficient quality systems for consistent delivery of products and services.