The Quality Assurance (QA) Module is an add-on for EthoVision XT that helps you protect your data and creates log files so you can easily keep track of everything that goes on during a project. It has been developed together with researchers and laboratory technicians from large pharmaceutical companies to facilitate compliance with quality assurance protocols and guidelines.
Why use the QA Module?
It is important to conduct research according to the highest quality standards. In order to obtain reliable and reproducible results, in-vivo animal research must be designed, conducted, analyzed and reported with appropriate rigor and robustness. Quality assurance is important in several steps of your study, from animal breeding, housing and feeding to data collection and analysis. Protocols and documentation play a crucial role in quality management. The QA Module helps you in an easy and efficient manner. The QA Module is of benefit for any EthoVision user who works in an industrial context. It is of particular value for EthoVision studies conducted under Good Laboratory Practice guidelines.
How does the QA Module help?
The QA Module is an add-on for EthoVision XT that provides user management and logging functionality. This allows you to very efficiently keep track of what goes on during the experiment and prevent intentional and unintentional data modification. Your data is safe and logs are created automatically.
User management means you can assign different rights to different users of EthoVision XT. You can prevent certain users to access certain projects (including GLP-compliant projects) altogether, and give other users specific rights that fit their role (e.g. professor, student, technician) in the study. Rights that can be assigned include:
- User management (add and remove users and assign rights)
- Preferences for use of the EthoVision XT software
- Experiment management (create experiments, make backups)
- Experiment settings
- Trial planning
- Arena settings / trial control / detection settings
- Acquisition (change settings a carry out acquisition)
- Import external data
- Edit tracks
- Edit track smoothing, data profiles, and analysis profiles
- Delete trials and clear log
The QA Module delivers several logs. The General log file provides a time-stamped list of user actions such as the creation of a new experiment, start and stop of an experiment, assigned users and user rights, and errors. Experiment log files document everything that happens from the moment you start acquiring data. It takes a snapshot of all the settings in the experiment and all changes that happen after that if they might affect your data. Both logs files are easily exported in HTML format and can be used for your Data Quality Report.
EthoVision XT allows you to create templates. For experiments that have to meet certain quality standards, creating such templates are a very useful feature.
Good Laboratory Practice
The QA Module is compliant with 21 CFR Part 11 (see FDA), the regulations on electronic records and electronic signatures for studies conducted under Good Laboratory Practice (GLP). GLP is a quality system for research laboratories to try to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical non-clinical safety tests. The regulations for GLP are described under the Code of Federal Regulations.
Part 11 defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. For Europe, the GLP rules have been compiled and adapted by the Organization of Economic Cooperation and Development (OECD).