EthoVision XT offers functionality to support the user in fulfilling quality requirements in in-vivo studies. The Quality Assurance (QA) functions can also be used to help comply with Good Laboratory Practice (GLP) regulations.
Quality Assurance functions
▪EthoVision XT user management
You can set up the program so that only authorized users are able to take particular actions, and that certain actions such as editing or deleting data are prevented.
All user actions which can result in changes to the acquired data (for instance altering settings) are logged and every time you leave a part of the program you are prompted to add a comment to the log file. This creates an audit trail suitable for a QA auditor to review.
important You need the EthoVision XT Quality Assurance module to use the Quality Assurance functions in EthoVision XT. See Modules of EthoVision XT
GLP (Good Laboratory Practice) is a set of rules for conducting non-clinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the U.S. Food and Drug Administration. These products include animal food additives, medical devices for human use, biological products and human and animal drugs. The principles of and regulations for GLP are described under the Code of Federal Regulations Title 21, Part 58 (CFR21/58).
For Europe, the GLP rules have been compiled and adapted by the Organization of Economic Cooperation and Development (OECD).
Subparts of the CFR21/58 GLP rules define and describe the following major points:
▪Organization and personnel.
▪Facilities.
▪Equipment.
▪Testing Facilities Operations.
▪Test and Control Articles.
▪Protocol for and Conduct of a Non-clinical Laboratory Study.
▪Records and Reports.
▪Disqualification of Testing Facilities.
All these items require to be managed in such a way that GLP-compliance is facilitated and ensured.
CFR21/11 more specifically describes guidelines for the use of electronic records.
important The Quality Assurance functions in EthoVision XT do not actively check that experiments made in EthoVision XT are GLP-compliant.