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This technical overview demonstrates how an Agilent 1260 Infinity II Online LC can be used in combination with the Flownamics SegFlow S3 and SampleMod modules for sampling from a bioreactor.
US FDA Part 11 in Title 21 of the Code of Federal Regulations (CFR), and its EU analog, Eudralex Chapter 4, Annex 11, describe the requirements for electronic records and electronic signatures for regulated pharmaceutical organizations.