Agilent Technologies, Inc.

Articles by Agilent Technologies, Inc.

Do you have questions about how to ensure data integrity? Then tune into this podcast series from LCGC. In this episode, hear from data integrity and quality systems expert Mark Newton about the shifting focus in data integrity, common problems and questions, and what you need to think about as you address data integrity in your company, or as you update software.

Do you have questions about how to ensure data integrity? Then tune into this podcast series from LCGC. In this episode, hear from data integrity and quality systems expert Mark Newton about dealing with data integrity issues arise in connection with sampling, sample preparation, aborted chromatographic runs, chromatographic integration, hybrid models, and more.

Do you have questions about how to ensure data integrity? Then tune into this podcast series from LCGC. In this episode, hear from data integrity and quality systems expert Mark Newton about the role of second-person review, the four Cs, training, oversight, and preparing for the future. 

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The advantage of UV spectroscopy as an analytical method to detect protein aggregation is that it is non-destructive and uses low sample volumes, minimal sample preparation requirement and easy sample analysis. A quick QC method to indicate the presence of aggregation uses an Agilent Cary 60 UV-Vis spectrophotometer to identify aggregation of mAb solutions resulting from different stress conditions.

Data integrity problems in pharmaceutical quality control laboratories are driving more regulatory action than ever before. It is obvious that something has changed to drive all this activity. There is plenty of information available, but much of it seems to confuse or frustrate rather than clarify or help. In this summary, we will provide clarity, dispelling confusion by looking at the facts, based on a study of available resources and direct interactions with FDA staff and their consultants. You’ll learn from Loren Smith, Agilent’s software compliance expert and a UC Berkeley instructor with 25 years of regulated software experience, how to put the current enforcement environment in historical context, and to apply critical thinking skills to what you hear or read regarding data integrity. You’ll also learn how to evaluate your current laboratory software and associated processes against these new expectations, as well as how vendors are redesigning laboratory software to help you respond to these new realities.