DownloadCase Study: Implementation of an Electronic Life Cycle Management System for Validation...and Beyond
A Case Study on Implementation of an electronic Solution for Validation Life Cycle Management resulting in Productivity improvements greater than 100% and Cycle Time improvements greater than 50%.
This paper discusses acceptance sampling by attributes and statistics involved in the application of ANSI ASQ Z1.4: Sampling Procedures and Tables for Inspection by Attributes. The paper focuses on how statistical formulas calculated using Microsoft Excel can be used to develop accept/reject criterion for a single sampling plan, how to compare...
Data integrity is a recent concern for the medical products industries, a result of the increased reliance on electronic software, records and signatures, stand-alone or networked. Initially there were regulations such as 21 CFR Part 11 in the U.S. and Annex 11 in Europe. But more must be done to ensure the integrity of CGMP documents / records...
This installment delves into robustness considerations for HPLC methods and identity and validation design for peptides characterization methods.
DownloadUnderstand and Address the Risk of Statistical Intervals as Acceptance Criteria in Process Performance...
Explore the concepts and some specific aspects of statistical intervals that must be understood to mitigate the risk of wrongly failing a PPQ batch. It also presents a tiered sampling strategy that could be implemented to not only avoid this situation, but also optimize sampling.
