Ponemah's Study Option Manual (MU00162)
The Study option allows the user to define a complete study before any data collection/analysis begins. This capability simplifies and manages the creation of data files in a toxicology-screening scenario and a non-toxicology-screening scenario. Once the Study information has been entered, the system will allow a user to log on, select an animal/treatment group from a list of available setups, calibrate, collect and analyze data, and then log off.
There will be no need for the user to select a protocol setup file or enter a data set name after a study has been created. The system will perform these actions automatically from the study information that has been entered previously.
The Study option maintains the creation of data file names. The files that are created and stored on the current workstation (.RAW, .RVW, WMV, etc.) can be copied to other workstations using the synchronize entire study utility. This eases the management of data files created by the application.
Using the Study option along with the Data Security option allows a part 11-compliant system (21 CFR Part 11) to be configured by an administrator before a study has begun. Once the study has been configured, a user can then select and acquire data for the study, eliminating the need to have the user manage the study data.
A study log is generated when the study is created. The study log will maintain a log of all changes made to the study, keeping track of when, by whom, and which changes were made.
Attached is the latest version of this manual.
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