Electronic records management package software CISAS/ER

CISAS/ER is a package software that can centrally manage measurement data collected by wireless loggers and graphic recorder that comply with FDA21 CFR Part11 as electronic records.
As a measure to protect measurement data in the event of a network failure, measurement data can be centralized in CISAS/ER upon recovery, preventing data loss.

Package software that complies with FDA21 CFR Part11 and complies with ER/ES pointer
System can be constructed with server/client configuration
Graph display by viewing data, daily reports, monthly reports, and reports can be created (printed and output as PDF files) and electronic signatures are possible

Package software to support data integrity

CISAS/ER is a package software that allows data recorded by our graphic recorder and wireless loggers to be centrally managed on a computer and managed as electronic records that comply with the requirements of FDA 21 CFR Part 11.
The following measurement data can be managed as electronic records:

Graphic recorder with measurement data protection function (KR2000/KR3000 series) data*1
Data from a wireless watcher with security function (wireless logger MD8000 series) *2
Data on equipment compatible with the data acquisition and monitoring package system (CISAS/V4)

*1 If Part 11 is not supported, graphic recorder (KR2000/3000 series) data without protection function can also be used.
*2 If Part 11 is not supported, data from a wireless watcher (wireless logger MD8000 series) without security functions can also be used.

Specifications

Model list

Name	Models
CISAS/ER (server)	PS3110-JNP
CISAS/ER (Client)	PS3111-JNP
Client license (additional)	PS9501

Software operating environment

CPU	CPU Intel Core2 Duo or higher memory 4GB or more (8GB recommended) DVD-ROM drive (for installation) Hard disk free space: 10GB or more (300GB or more recommended) LAN/USB port (Type-A)
display	Color high resolution 1024 x 768 pixels or higher
Printer	Windows compatible
OS	Windows 11 (64bit) Windows 10 (32bit/64bit) Windows 7 (32bit/64bit) *.NET Framework 4.0 or later must be installed.
Database	Microsoft SQL Server Standard or higher (sold separately) Microsoft SQL Server Express (database up to 10GB)

Applicable models

Recorders	Graphic recorder with measurement data protection function KR3000 series
Wireless Devices (Japan Only)	Part 11 Compliant Wireless Logger with Monitoring Function MD8000 Series

Download Documents & Softwares

Catalog

Specification Sheet (PS Sheet)

CAD Data

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Instruction Manual