Navigating the intersection of technology and human expertise in life sciences

[Adobe]

In this age of rapidly evolving technologies that fundamentally shift the way businesses operate, such as large language models (LLMs) and natural language processing (NLP), organizations are quickly realizing that success extends beyond innovative technology solutions alone. While these technologies offer immense potential in terms of innovation, data insights and operational efficiency gains, constraints exist in areas such as meeting regulatory requirements, managing data availability/ date volume/ data congruence and, in some cases, ensuring commercial viability. These limitations must be addressed for successful adoption across the healthcare industry and for implementation of such tools into broad based quality management systems and product solutions.

True success hinges on the effective implementation and strategic utilization of technology, guided by human expertise and supported by well-designe…

Read more
  • 0

FDA issues draft guidance on medical device production and quality system software assurance

The FDA wants feedback on its newly issued draft guidance for practices relating to computers and automated data processing systems used as part of production or quality systems.

The FDA is taking comments on its new draft guidance, “Computer Software Assurance for Production and Quality System Software,” until Nov. 14.

The agency’s goal is to offer recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or quality systems. FDA said the new guidelines follow manufacturing advances in areas such as automation, robotics and simulations that can improve the quality, safety and availability of medical devices.

FDA said medical device manufacturers have asked not only for greater clarity on validating production and quality software, but also a “more iterative, agile approach.”

RELATED: Taking the extra steps to ensure medical device quali…

Read more
  • 0