Issue link: https://www.e-digitaleditions.com/i/1462272
www.biopharminternational.com Quality and Regulatory Sourcebook eBook March 2022 BioPharm International 15 How a Lack of Critical Thinking is Hindering Regulatory Compliance Why critical thinking must be applied before technology to ensure regulatory compliance. T hroughout a single project, contract devel- opment and manufact uring organizations (CDMOs) generate an abundance of essential data that require an array of computerized sys- tems 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 con- trols 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 pre- dominant challenge to achieving regulatory compliance, but the lack of critical thinking skills when designing a quality system. IMPORTANCE OF SAFEGUARDING DI Over the years, technological advancements have both accel- erated the digitalization process while highlighting the many complexities involved in ensuring DI. CALVIN KIM Quality and Regulatory Sourcebook Regulations: Data Integrity Andrii Zastrozhnov - Stock.adobe.com CALVIN KIM is the senior director, head of IT quality systems and validation, for Samsung Biologics.