ResourceGeneral Lab
FDA Regulations on Electronic Records - FAQs and Applicability to Temperature Monitoring Systems
1 Jul 2019In this whitepaper, B Medical Systems explains the scope of usage and applicability of 21 CFR Part 11 in day-to-day operational scenarios and discusses how remote temperature monitoring systems, integrated to medical devices such as lab refrigerators or freezers, comply with the standards set by the FDA regulation. Amongst others, °B Connected – a remote monitoring solution developed by B Medical Systems that generates electronic records – meets the technical controls of 21 CFR Part 11 regulation, thereby providing an extra layer of assurance for FDA submissions.
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Refrigerators Freezers and CryogenicsRefrigerators, Freezers & Cryogenics can be used for preservation or experimental purposes. Types of freezers include deep freeze, -80C°C, ultra-low temperature, explosion proof, cryogenic and controlled rate freezers. Freezing is also used in freeze-drying equipment for dehydration processes. Feature to consider in freezers include temperature control and recorders, failure alarms and self-closing mechanisms.Laboratory ManagementLaboratory management involves overseeing the operations of a lab, ensuring compliance with safety regulations, optimizing workflows, and maintaining equipment. Efficient lab management is key to ensuring accurate results and minimizing downtime. Technologies like laboratory information management systems (LIMS) and automated lab equipment are helping labs streamline operations. Browse our peer-reviewed product directory to find the best laboratory management tools, compare products, read reviews, and get pricing directly from manufacturers.FDAThe Food and Drug Association (FDA) is an agency within the U.S. Department of Health and Human Services. Among other things, it is responsible for ensuring the safety, effectiveness and quality of drugs, vaccines and other biological products, and medical devices. ULT FreezerSample StoragePreserving clinical trial samples to the highest standards is a critical component in maximizing the value of present day and future clinical research. Specialized storage and transportation of these tissue, blood and serum samples reduces the risk of them being damaged or lost.
