Preclinical Data Collection Software [TOX LAUNCHER]

Fundamentals and Functions

Installation
♠Allows you to select modules from a wide assortment of functions fit your
   installation plans.
   TOX-LAUNCHER consists of several divisions organized by functions.
   Each division is developed by modules that are smaller than those found in other
   preclinical data solutions.
   Users can select a minimum number of applications based on your necessities.
♠Allows you to selecting from various module types to stay in accordance with
   operating procedures for eachlaboratory.
♠One-year free technological support for all modules.


System Expansion
♠System and data linkage between any TOX-LAUNCHER systems is possible even if
   the software is installed independently.


The Study Information
♠Flexible correspondence with unexpected collected study data besides the
   standard study protocol.
   Enter necessary data into the system, even when the data is collected in urgent
   situations.
   Instead of the data is not allowed to be entered into the system, it approves to
   enter the data with records.
♠Management study information up to 1000 animals/ 30 groups.


Study Management
♠Simple enter study information by using study management information templates.
   Study information record will be copied (reproduced), and template is created for
   the future use.
♠Outputting the work schedule to any scheduler.
♠Grouping can be done automatically.
   Grouping is done randomly, sequentially, or by weight.
♠Set starting date of administration and administration unit for each group.
♠Appropriate management of study data after the study is completed.
   Output and saving the study data to other media.
   Possible to modify past study data which is already saved into media and
   restore the data.


FDA 21 CFR Part 11 Compliance
♠Compliance with FDA 21 CFR Part 11.
   Improving information gathering and research towards system compliance with
   FDA 21 CFR Part 11.
   *Please refer to 'The Functions and Developments of TOX-LAUNCHER' for more
   information on H & T's ideas and approaches to FDA 21 CFR Part 11 compliance.


Software Validation Support
♠The Documentation
         User Requirement Specification (URS)
         Functional Specification (FS)
         Architecture Design Specification (ADS)
         Software Design Specification (SDS)
♠Validation
   H&T can help users conduct software validation- IQ(Installation Qualification),
   OQ(Operational Qualification),PQ (Performance Qualification) according to the
   validation documents.
♠Validation Results
   Validation Reports available with the validation evidences.
   Options :
   GAMP Validation Support Package
   *Please refer to the GAMP Validation Package pamphlet for more information.


Weight Measurement (Body Weight, Food and Water Consumption, Organ Weight)
♠Allows entering measurement data directly into the system from the electronic
   balance.
         Allows entering data with keyboards.
         Compatible with the electronic balances below
         -Sartorius LA Series
         -Mettler Toledo PG-S Series
         -A & D Company, Ltd. GF Series
♠Allows saving the calibration record of the measurement device.
   Allows conducting the device calibration at the beginning, during, and at the end of
   the measurement.
♠Allows setting the designated rate range of body weight.
   Shows warning message when data is outside the accepted bounds.
♠Allows entering “NE” (Not Examined, with entry of NE comment) and “Dead” as the
   measurement results besides the value.
♠Allows printing/creating PDF file for recent data after the end of each measurement.
♠Allows measuring at irregular points? unscheduled measurement is always accepted.
♠Allows measuring under-inspection animals and extra animals.
♠Allows recording the forced administration.
♠Allows continuous operation under network error.
♠Allows starting the measurement from any organs.


Clinical Chemistry (Blood, Urine, Biochemistry)
♠Allows setting scheduled measurement plan settings and measuring at unscheduled
   points.
♠Allows inputting the measurement data directly into the computer from analyzer
   and automatically summarizing the collected data.
♠Allows showing the measurement results in real time and easily detects data error.
   Errors in data are shown in red or indicated by ringing an alarm.
   (Out of standard value (maximum and minimum value) range, measurement error,
   etc.)
♠Allows registering the frequently used test models and simplifying to create test
   information.


Pathology (Gross Pathology and Histopathology)
♠Allow data management and summarization of the gross and histopathology
   observations.
   Allows a flexible definition of grade, permitting use of whatever arbitrary symbols
   are consistent with each laboratory's representation.
♠The system provides continuous operation despite the network troubles.
   By saving the data on the client's database, the system allows continuous operation
   temporarily, regardless of the server and network troubles.
♠Allows entry of comments and memos to be added to the observation data.
   Allows a comment for each observation, for which the changes will be saved to the
   logs and allows tracking.
   Allows a 'memo' for each observation, for which change logs are unnecessary.
♠Allows adding new observations to the 'Pathology Glossary' while observing gross
   pathology and histopathology.
   Allows immediate correspondence on detection of new observations that are not in
   the 'Pathology Glossary' list during study.
♠Allows making correlations between gross pathology and histopathology
   observations.


Reports and Tables
♠Creating and saving in Microsoft® Excel and PDF format.
♠Excel Template System- Free-editing templates
         Allows adding and editing the template file.
         Allows creating flexible report format according to users' requirements.
         Familiar-to-use Microsoft® Excel templates.
♠Assimilation Search Function
         In Pathology Systems, allows assimilating observations with other similar
         entries (determined by certain criteria), allowing various summarizing of the
         Idata without modifying the raw data.
         In Organ Weight Systems, allows measuring bilateral organs (eg. lungs
         and kidneys) independently, but also offers the option to sum while tabulating.


Security
♠Allows integrated system management by unifying and controlling the system
   security.
♠Allows user access authorization management by their role in the study, which is
   adaptable to operational procedure.
♠Prevents unauthorized users from abusing and improperly manipulating data with an
   already logged in user identity.
   Periodic user re-authentication helps prevent improper data input by unauthorized
   users.
♠User authentication through biometric equipment.


GLP Compliance
♠Log Management for each data collection modules
         Allows managing the change logs on raw data.
♠Administration Management
         Allows detecting and checking unmeasured and unscheduled measurements.
♠Auto-Validation System for all each modules
         Allows detecting changes in system operation and environment automatically.
♠For all reports, can prevent changes to existing report files created by users.
         The reports and tables created are locked and protected from data alteration.
♠Additional module installations
         The Selectable System and Auto-Validation System allow simple addition of
         functions by validating the running applications that have not been affected by
         the new installations.
♠OS upgrade and hardware replacement
         Allows easy OS upgrades and data migration when replacing hardware through
         the Auto-Validation System, by validating the running applications that have
         not been affected by the upgrades or replacements.

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