ResourceLife Sciences
Cleanroom Routine Environmental Monitoring – FDA Guidance on 21CFR part 11 Data Integrity
31 Aug 2017Despite guidance from the FDA, cleanroom environmental monitoring remains an intensely manual process, with many opportunities for human error to create gaps and errors in the data. In its 21CFR part 11 guidance, the FDA have given recommendations on what good data integrity looks like. This and this white paper explains the FDA’s advice in the context of current cleanroom environmental practices and shows how FDA guidance can be applied to improve data integrity.
Links
Tags
Cell / Tissue CultureCell culture or tissue culture is used to study the biology of cells or tissues and to isolate cellular products in an environment which can be manipulated and well defined. Accurately control your culture environment with bioreactors or culture incubators, bind your cells to a surface or together with an extracellular matrix. Distinguish cell types with differential media or proliferate cells with certain characteristics using selective media. Enrich your media with supplements such as growth factors, sera and vitamins. Find the best cell and tissue culture products, kits and equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct 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. BiopharmaceuticalsBiopharmaceuticals are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or for in vivo diagnostics. The most well known example of a biopharmaceutical product, and the first to be approved for therapeutic use, was recombinant human insulin.