Ligand-Binding Assays in the 21st Century Laboratory: Recommendations for an Automated Data Interchange Process
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KEY WORDS21 CFR Part 11 automated data interchange common data standard ligand-binding assays metadata
Application programming interface
Electronic Records and Electronic Signatures regulations (US FDA 21 CFR Part 11)
Good Laboratory Practice regulations (21 CFR Part 58)
Globally unique identifier
Liquid chromatography/mass spectrometry
Laboratory information management system
Software development kit
Universal serial bus
The authors would like to acknowledge Jim King’s efforts in initiating this effort, Chad Briscoe’s participation on this subcommittee, and Ago Ahene, Marian Kelley, Denise O’Hara, Jean Lee, and Philip Oldfield for their review and comments. This manuscript was prepared by members of the 21st Century Bioanalytical Laboratory: eSolutions Subcommittee of the Ligand Binding Assay Bioanalytical Focus Group (LBABFG).
Conflict of interest
This article describes two commercial systems: MasterPlex® from Hitachi Solutions America and Integration Manager from Thermo Scientific. Robert Lynde and Joel Usansky are employees of Hitachi Solutions America and Thermo Scientific, respectively. These two systems were provided as examples of commercially available systems that do not provide a complete solution. To the authors’ best knowledge, due to the lack of a universally accepted automated data interchange process, there are currently no commercially available systems that provide the complete solution that we seek.
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