Software Validation: Answers to Frequently Asked Questions
Question: How is change control used to keep software validated?
Answer: It is normal that any system needs to be changed over time because of changes in business needs and software updates. The objective is to make sure that those changes are described properly, that the impact and risk of that change is well understood, and that there is documentation to support that assessment of the impact and the risk. A determination is then made regarding the degree of testing or revalidation work that would be required to re-establish that the system is still behaving according to its intended use in the process where it’s going to be used.
Study Explores Thin-Film Extraction of Biogenic Amines via HPLC-MS/MS
March 27th 2025Scientists from Tabriz University and the University of Tabriz explored cellulose acetate-UiO-66-COOH as an affordable coating sorbent for thin film extraction of biogenic amines from cheese and alcohol-free beverages using HPLC-MS/MS.
Automating Protein Purification: Efficiency, Yield, and Reproducibility
March 27th 2025Recent advancements in automated protein purification stress the importance of efficiency, scalability, and yield consistency. This eBook compares different purification platforms, highlighting their impact on downstream applications and demonstrating how automation enhances throughput and process control.
