ARTICLES BY KIP WOLF
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![social-networking-GettyImages-1029144458]( "Attributable Data Integrity in Modern Biopharma Using ALCOA Principles")
Attributable Data Integrity in Modern Biopharma Using ALCOA Principles8/29/2022This article is the first in a five-part series providing contemporary, practical, and useful examples of data integrity within each of the five traditional principles of ALCOA. This article centers on A: Attributable.
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![Data Folder]( "Why Data Integrity Is Impossible Without A Quality Culture")
Why Data Integrity Is Impossible Without A Quality Culture2/19/2019For 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.”
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![Cheating In The Lab: 3 Data Integrity Pitfalls To Avoid In Laboratory Operations]( "Cheating In The Lab: 3 Data Integrity Pitfalls To Avoid In Laboratory Operations")
Cheating In The Lab: 3 Data Integrity Pitfalls To Avoid In Laboratory Operations1/17/2018At least 20 percent of all warning letters issued by the CDER Office of Manufacturing Quality in 2017 included explicit observations by inspectors of blatant data integrity violations in laboratory operations. It is incumbent upon us to enforce and reinforce basic CGMP and GDocP practices in our own laboratories and those of our suppliers
Kip Wolf
Kip Wolf is head of technical operations and portfolio management at X-Vax Technology, Inc. His technical experience includes the fields of quality assurance and regulatory affairs, GMP and IT compliance, technical operations and product supply. His areas of leadership expertise include business transformation, new business development, organizational change leadership and program / project management. He has led business process management groups at Wyeth Manufacturing and Merck Research & Development. Prior to joining X-VAX, he supported the company as a principal consultant at Tunnell Life Sciences Consulting, where he also led the data integrity practice. Wolf can be reached at kwolf@x-vax.com.