Yelena Ionova is senior manager, Data Strategy and Analytics with Redica Systems.
Specification Equivalence: A Practical Approach to Method and Acceptance Criteria Equivalence
August 27th 2025The authors propose a streamlined, efficient approach to determining specification equivalence that starts with a paper-based assessment of the methods and progresses to a data assessment for the methods under evaluation.
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.