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Why critical thinking must be applied before technology to ensure regulatory compliance.
Throughout a single project, contract development and manufacturing organizations (CDMOs) generate an abundance of essential data that require an array of computerized systems to manage. These systems provide many benefits, including reducing human error, making processes more efficient, and enhancing security. More importantly, these systems can be used to help implement technical controls for data integrity (DI).
The importance of ensuring DI, particularly when data are used in decision-making for the regulated good practice (GxP) processes, is highlighted by the consistent updating of regulations first mandated by FDA in the early 1960s. Since that time, FDA and other regulatory agencies have continued to publish guidance emphasizing the need to maintain DI controls.
Before any new technology implementation, CDMOs need to fully understand the system as well as establish its intended use and perform risk mitigation to ensure robust DI controls. However, understanding and implementing the requirements of regulations surrounding computerized systems continues to be a challenge to many CDMOs today. Technology is not the predominant challenge to achieving regulatory compliance, but the lack of critical thinking skills when designing a quality system.
Read this article in BioPharm International’s March 2022 Quality and Regulatory Sourcebook eBook.
Calvin Kim is the senior director, head of IT quality systems and validation, for Samsung Biologics.
eBook: Quality and Regulatory Sourcebook
When referring to this article, please cite it as C. Kim, "How a Lack of Critical Thinking is Hindering Regulatory Compliance," BioPharm International's Quality and Regulatory Sourcebook eBook (March 2022).