Data Integrity in Pharmaceutical Quality Control Laboratories: What You Need to Know
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 whitepaper, 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.
Simplifying the GC Laboratory for Improved Efficiency
December 9th 2024Laboratories continually work to increase the capacity of their equipment, improve turnaround times and gain confident and detailed insights without generating additional burden on their operators. Discover how adopting the simplification strategy of Industry 4.0 with the GC 2400™ Platform can enhance GC workflows to increase efficiency, data quality, and business sustainability
How to Enable Sustainable GC Lab Operations
December 9th 2024Sustainability strategies are being integrated into a growing number of businesses and their operations. Laboratories are no exception. Although the necessity to reduce the environmental impact of laboratory operations is recognized, it cannot be disengaged from the economic viability of labs. This article shares ways in which laboratories can improve both their business and environmental sustainability and discusses how the GC 2400™ Platform is helping laboratories flourish in these areas
What Are the Key Features of a Smart and Connected GC Lab?
December 9th 2024The potential of smart technologies has evolved into a operational necessity - businesses were faced with the need for remote and automated operations bringing substantial improvements in productivity, efficiency, and operating costs.
Automated PFAS Extraction from Difficult Food and Food Packaging Samples
December 6th 2024More and more regulations regarding PFAS are being implemented with action limits that continue to decrease. Having a harmonized method to accurately determine the PFAS content in food, as well as other matrices, is important to ensuring long-term detection and regulation. The solvent extraction of PFAS from these varied sample matrices can be challenging given the susceptibility to contamination and the low levels in which these compounds are present. This poster, presented at RAFA 2024, examines the PFAS extraction several different food samples as well as food packing matrices.
Extraction of 40 PFAS Compounds from Soil and Tissue
December 6th 2024PFAS have been shown to cause health issues in humans, which means monitoring environmental solid samples, such as soil and tissue, is critical. This application note details the extraction of 40 spiked PFAS compounds from soil and tissue following EPA Method 1633. The automated extraction was less than 10 minutes per sample and yielded acceptable recoveries and RSDs without carryover in the system. The EDGE PFAS is an ideal option for laboratories that want to automate their PFAS extractions of solid samples.
