ARTICLES BY KIP WOLF

• Canaries In A Coal Mine: Can Better Data Integrity Thwart A Looming Deepfake Threat?

  7/15/2020

  If you think deepfake security risks are purely science fiction, think again. Not only does the technology exist and the content is readily available to facilitate such activities, but incentives to carry them out are multiplied in the current economic, social, and political environment.

• AI, Data Integrity, & The Life Sciences: Let's Not Wait Until Someone Dies

  6/18/2019

  Simply performing computer system validation or managing computer systems under CGMP conditions is not enough to ensure data integrity and data quality for data sets where AI/ML is intended to be applied.

• Using The QTA To Align Data -Integrity Expectations

  3/1/2019

  “FDA believes that quality agreements can be extremely valuable in delineating the activities of all parties involved in contract research and development arrangements.”

• Why Data Integrity Is Impossible Without A Quality Culture

  2/19/2019

  For successful establishment and sustainability of a quality culture, “the mindset and behavior... must start at the top and be emulated by individuals at all levels and in all functions within the company.”

• Startups, Cloud Storage, & Data Integrity: Don't Let This Happen To You!

  12/5/2018

  Data integrity is of paramount importance to ensure patient health and safety and to improve shareholder value, particularly for virtual companies. Startups finding themselves in the throes of managing complex drug development programs realize they may face great risk if they do not begin with the end in mind and integrate data integrity practices early on.