H+T recently completed the installation of the company's weight measurement subsystem at the life science research laboratories of Kaneka in Hyogo, Japan
The Weight Measurement subsystem is part of H+T's flagship Tox-launcher series, and is designed for the management of experimental data generated from body weight, food consumption, water intake and organ weight tests administered during preclinical stage pharmaceutical drug development.
According to Hikaru Tanaka, vice president at H+T and a former pharmaceutical research scientist, the Weight Measurement subsystem and the other subsystems of the Tox-launcher series are different from conventional pharmaceutical software products in that they allow the user to add or append information as the study evolves.
"Current systems only allow for the scheduled input of information.
"If you observe something unexpected or if you make a mistake in recording the information, there is no simple method for amending the data.
"However, with the flexible design of the Weight Measurement subsystem and the other products from the Tox-launcher series, you are able to include such information, simplifying the process and ultimately increasing the value of the research," says Tanaka.
"Also, because the Weight Measurement subsystem can be used in combination with the Pathology subsystem (and other Tox-launcher subsystems), researchers can avoid the tedious process of entering the same basic study information for each subsystem".
Some of the other features that the Weight Measurement subsystem and the other subsystems of the Tox-launcher series provide include: compliance with both good laboratory practice (GLP) and FDA 21 CFR Part 11 (electronic records/electronic signatures) regulations, and automatic system validation.
The flexible system design described above would be of no value if not supplemented with compliance to the strict regulations that govern pharmaceutical research.
As a result, H+T has put a great deal of consideration and effort into meeting these regulations; creating a product with the stability necessary for long term compliance.
In addition, products from the Tox-launcher series are endowed with H+T's Auto-Validation feature, which automatically performs operational qualification (OQ) as laid out in GLP regulations.
This provides a significant advantage relative to conventional systems, which require up to several months for OQ testing to be carried out manually.
Auto-Validation, therefore, allows the user to add or exchange any hardware or software easily and without fear of delaying the trial.
Thus, researchers no longer have to postpone OS updates, or avoid the installation of useful software/hardware on computers managing the trial.
The Weight Measurement subsystem and the other subsystems from the Tox-launcher series are all available as packaged software, and require no customization.
However, due to H+T's 'selectable system' installation option, the customer has the ability to select only those modules and features that are necessary for his or her particular research.
In addition, the customer is given the freedom to add modules following the initial installation of the software, reducing the cost associated with both the management and installation of the system.
Kaneka used this method during the recent installation at its life science research laboratories, and was able to select and install only those modules corresponding with the research to be performed.
