8 DECEMBER 2023IN MY OPINIONQuality Assurance (QA) in Pharma Tech has undergone substantial transformation, with a strong focus on regulatory compliance, data integrity, and risk management. Tony Johnson, Senior Director, Global Clinical Quality Assurance, Mallinckrodt Pharmaceuticals, discusses how emerging technologies like blockchain, AI-powered analytics, and automated validation are becoming integral to quality systems. Global Clinical QA for Innovation and ComplianceWith the understanding that the objective of emerging technologies such as blockchain and AI-powered analytics is to gain a suitable assessment of activities promptly, Global Clinical Quality Assurance can use the technologies to prioritize assessments in those areas where the risks can compromise patient safety or data integrity. For example, there may be a dependence on clinical site personnel and CRAs to ensure the investigational product (IP) is always stored within the appropriate temperatures. Blockchain technology can provide temperature data in real-time to promptly alert those that the IP may have been impacted before the product's administration. Navigating QA Technology Challenges for Business SuccessThe biggest benefit for an organization when QA implements new technologies is the ability to monitor clinical research activities more expeditiously than the typical monitoring process, which can lead to minimizing the impact of identified concerns. However, the challenge with using new technologies is the financial, time commitment, and resources needed to properly implement the processes and systems to realize their benefits. To overcome these challenges is to analyze and convey that the ability to identify and address concerns will translate into regulatory applications submitted earlier, and the increased probability of marketing approval means will provide patients with access to the therapies sooner than the historical approaches commonly used. By Tony Johnson, Senior Director, Global Clinical Quality Assurance, Mallinckrodt PharmaceuticalsQUALITY ASSURANCE TRANSFORMATIONS AND INNOVATIONS IN PHARMA TECHTony Johnson
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