Incorporating AI into the Process Validation Lifecycle: A Two-Way Street: Poster Presented at PDA Week 2025

Alyssa Burke1

  • 1BW Design Group, St. Louis, MO, USA alyssa.burke@bwdesigngroup.com.

Abstract

Related Concept Videos

Data Validation01:03

Data Validation

Data validation is an essential part of a comprehensive assessment. Validation is confirming or verifying and opening the door to gathering more assessment data as it clarifies vague or unclear data. The process of checking and verifying the collected information is called data validation. The primary purpose of data validation is to ensure data is as free from error, bias, and misinterpretation as possible.
Nursing assessment guides are generally based on holistic models rather than medical...
5.3K
Quality Assurance01:19

Quality Assurance

Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
202
Introduction to Statistical Process Control01:15

Introduction to Statistical Process Control

Statistical Process Control (SPC) is a method used to monitor and control quality within processes, particularly in manufacturing and service delivery, by employing statistical methods. SPC aims to distinguish between natural (common cause) variation and variation due to specific changes or events (special cause), allowing for timely improvements and sustained quality. The control chart, a pivotal tool in SPC, visually displays data over time alongside a central line of upper and lower control...
250
Non-equilibrium in the Cell01:16

Non-equilibrium in the Cell

An important concept in studying metabolism and energy is that of chemical equilibrium. Most chemical reactions are reversible. They can proceed in both directions, releasing energy into their environment in one direction, and absorbing it from the environment in the other direction. The same is true for the chemical reactions involved in cell metabolism, such as the breaking down and building up of proteins into and from individual amino acids, respectively. Reactants within a closed system...
4.8K
Quality Control01:05

Quality Control

Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
Quality control helps track data, visualize trends, and identify variations, making it easier to detect deviations that may affect the accuracy of an analysis. One way to do this is by generating a quality control chart, which...
286
Improving Translational Accuracy02:07

Improving Translational Accuracy

Base complementarity between the three base pairs of mRNA codon and the tRNA anticodon is not a failsafe mechanism. Inaccuracies can range from a single mismatch to no correct base pairing at all. The free energy difference between the correct and nearly correct base pairs can be as small as 3 kcal/ mol. With complementarity being the only proofreading step, the estimated error frequency would be one wrong amino acid in every 100 amino acids incorporated. However, error frequencies observed in...
11.9K