Victoria Lander | Authors

Victoria Lander is the Corporate Compliance Manager at Waters Corp., Milford, Massachusetts. She is responsible for marketing and market development for scientific corporate compliance initiatives and products focused on the pharmaceutical industry. Victoria received the B.S. degree in Biology and the B.A. degree in Psychology from Purdue University.


21 CFR Part 11 and Risk Assessment: Adapting Fundamental Methodologies to a Current Rule

The current final FDA guidance document discussing the revised scope and applicability of 21 CFR Part 11 clearly adopts a risk-based approach to Part 11 compliance. This is certainly a very pragmatic approach and one that many regulated firms had adopted even before the recent release of this document. This article will discuss the particulars of a risk-based approach to Part 11 compliance. The favored risk assessment protocols such as HACCP, FMEA and FMECA will also be addressed as well as how one can apply them to 21 CFR Part 11 compliance.