三井造船システム技研株式会社 Mitsui Zosen Systems Research Inc.

IT SOLUTIONS FOR PHARMACEUTICAL COMPANIES

HISTOPATHOLOGY SYSTEM

Histopathology system is a system which is compliant with GLP*, FDA21CFR Part11* and MHLW ER/ES* regulations. This system prepares Protocol, designates organs and animals which are subjects to be examined, and collects data of findings from histopathological necropsy and tissues and outputs the report. This system has functions to aggregate calculation, and statistical process of findings. This system brings you data quality and rationality. By using Data link function of MiTOX, Protocol preparation is simplified and related data can be referable.


CONCEPT CHART

HISTOPATHOLOGY SYSTEM
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CHARACTERISTICS

Easy Data Entry

Histopathology system not only allows anyone easily to perform a data entry, but also is a GUI-designed to be able to view data entry status at one view.

Definition of Raw Data

Times taken for operations are recorded at the time of data registration with histopatholoical analysis and necropsy. When a paper is regarded as raw data, or when data from histopathology system is regarded as raw data, entry can be operated for each raw data at own discretion.

Coalition with MiTOX*

If you were a user of MiTOX, you could refer to the Protocol set in MiTOX (import to histopathology system), and the Protocol can be easily prepared. MiTOX has an incorrect operation prevention function such as when only the taken out animals are the subjects, and support function will be added which allows people to view data in individual organ weight, urinalysis, biochemical examination and clinical observation.

Findings from Histopathological Necropsy and Tissues

Entry, referring and correction of data are possible during a periodical necropsy and/or death during an examination, etc. Data correction history management is performed for fixed data, and not for unfixed data correction.

Focuses

Histopathology System focus on the following.
・Increase productivity
・Statistical analysis by SAS
・Assurance of data integrity and quality
・Many achievements of system introduction and data submission
・Flexibility of the system
・Histopathology System meets the user requirements
・Fully compliant with GLP
・Compliance with FDA 21 CFR Part11
・Compliance with MHLW ER/ES
・The findings dictionary will be created for each studies.
・ Histopathology System also supported carcinogenicity studies.

(*MiTOX)
Mitsui Toxicological Data Processing System
(*GLP)
Ministry ordinance: Nonclinical safety studies that are used to support the development of a pharmaceutical should be conducted in accordance with Good Laboratory Practices.
(*FDA 21 CFR Part 11)
U.S.C.: Electronic Records, Electronic Signatures
(*ER/ES)
ER/ES: Guideline for the use of electromagnetic records and/or electronic signatures in applications, etc. for authorization or permission regarding pharmaceuticals and other items.

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