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.
RAFA 2024 Highlights: Cutting-Edge Chromatography Techniques for Food Safety and Food Analysis
November 18th 2024An illuminating session focusing on progress in analytical techniques used in food analysis took place on Wednesday 6 November 2024 at RAFA 2024 in Prague, The Czech Republic, including a talk on the analysis of 1000 toxins in 10 minutes.
RAFA 2024 Highlights: Contemporary Food Contamination Analysis Using Chromatography
November 18th 2024A series of lectures focusing on emerging analytical techniques used to analyse food contamination took place on Wednesday 6 November 2024 at RAFA 2024 in Prague, Czech Republic. The session included new approaches for analysing per- and polyfluoroalkyl substances (PFAS), polychlorinated alkanes (PCAS), Mineral Oil Hydrocarbons (MOH), and short- and medium-chain chlorinated paraffins (SCCPs and MCCPs).
AI and GenAI Applications to Help Optimize Purification and Yield of Antibodies From Plasma
October 31st 2024Deriving antibodies from plasma products involves several steps, typically starting from the collection of plasma and ending with the purification of the desired antibodies. These are: plasma collection; plasma pooling; fractionation; antibody purification; concentration and formulation; quality control; and packaging and storage. This process results in a purified antibody product that can be used for therapeutic purposes, diagnostic tests, or research. Each step is critical to ensure the safety, efficacy, and quality of the final product. Applications of AI/GenAI in many of these steps can significantly help in the optimization of purification and yield of the desired antibodies. Some specific use-cases are: selecting and optimizing plasma units for optimized plasma pooling; GenAI solution for enterprise search on internal knowledge portal; analysing and optimizing production batch profitability, inventory, yields; monitoring production batch key performance indicators for outlier identification; monitoring production equipment to predict maintenance events; and reducing quality control laboratory testing turnaround time.
SPME GC-MS–Based Metabolomics to Determine Metabolite Profiles of Coffee
November 14th 2024Using a solid phase microextraction gas chromatography-mass spectrometry (SPME GC-MS)-based metabolomics approach, a recent study by the School of Life Sciences and Technology at Institut Teknologi Bandung (Indonesia) investigated the impact of environmental factors (including temperature, rainfall, and altitude) on volatile metabolite profiles of Robusta green coffee beans from West Java.
