An audit trail is assigned to every data file recording data manipulations on special data. Three levels of electronic signatures are required including a creation, review, and approval stages. Spectra Manager CFR provides secure access and compliance features for 21 CFR Part 11, system Access requires user name and password which are assigned by the Workgroup Manager and Access Level determines access to Administration Tools which includes instrument installation analysis application installation, user setup, workgroup setup, security policy as well as system and application history logs. Digital and graphical data transfer through the clipboard. To make BeStSel accessible to biopharma, JASCO developed Spectra Manager Ver.2.Multi-tasking allows background data aquisition while analyzing data or running other programs.Overlay printing in colors and patterns.Audit trail stored as part of a data file.Partial list of data manipulation functions: Each instrument driver has a module to allow for instrument hardware diagnostics and validation. Data acquired from each instrument is automatically loaded to the analysis program (running in the background) in order to free up the PC and control software to acquire more data. Parameter setting screens allow easy editing of pre-saved parameter files. Spectra Manager II Suite includes a validation application that can be used to evaluate the performance of both the FT/IR-4000 and FT/IR-6000 Series of instruments. UV/VIS/NIR, Fluorescence, FT/IR, CD, ORD, LD, Raman, FT-Raman Polarimeters and other types of data files can be directly compared, processed, and printed together.ĭrivers are available to control each JASCO spectrophotometer. The combination of a short pathlength (10 µm) cell and Spectra Manager 2.5 BeStSel CFR with highly accurate absorbance data measured simultaneously by CD spectroscopy allowed us to evaluate the HOS of the antibody in its formulated state without dilution. The approach of having a single platform for data analysis is a unique and powerful way to manipulate and display data from any JASCO spectroscopy system. Spectra Manager II is the latest version of the JASCO innovative cross-spectroscopy software platform.
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