Noldus - GLP/21 CFR Part 11


GLP/21 CFR Part 11
Studies conducted under GLP regulations must follow strict guidelines of study preparation and performance, including stringent record-keeping and logging of experiment conditions. 21 CFR Part 11 handles electronic records and signatures under GLP.
EthoVision XT's GLP module causes EthoVision XT to be beneficial for GLP compliant environments. Now these environments can also benefit from its outstanding technology. When using the GLP module your experiments are:
safeguarded Only authorized persons are able to start the program. Users need to log into the program by entering their user name and password. User management rights guarantee that users can only perform tasks that are assigned to them. Some basic EthoVision XT functions are disabled or differ whenever the GLP module is used. This enables you to meet 21 CFR Part 11 requirements.
logged A non-editable audit trail records all changes made by a user that could influence the experiment results. Association of logged changes with date, time, and user making them. The audit trail contains snapshots of all experiment settings used. As soon as the first data has been acquired, experiment settings can no longer be changed. User comments can be added to the log file at any time. retrievable Deleting of trials is by default disabled. Experiment logs can be viewed, exported, and printed.
For more information about EthoVision XT's GLP functionality, please out a form to request information.