Secure Software for Use with OM-CP Series Data Loggers

OM-CP-SVP-SYSTEM

^¥375,900 OM-CP-SVP-SYSTEM

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Install, Validate and Operate One Software Program Universally
Compatible with Most OM-CP Series Data Loggers
Time and Cost Saving Validation Package–Stands up to Interrogation from Auditors
Automatic Data Security and Audit Trail
Sophisticated User Maintenance
Traceability with Customizable Electronic Signatures and Audit Trails
Aids in Compliance with FDA 21 CFR Part 11/820 and GxP Guidelines
Applications: Pharmaceutical, Medical, Hospitals, FDA Regulated Organizations, Temperature Mapping

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商品説明

The OM-CP-SVP-SYSTEM Secure Software aids customers in compliance with 21 CFR Part 11 requirements. The software ensures standards in which electronic files are considered equivalent to paper records, saving time and effort.
OM-CP-SVP-SYSTEM Secure Software contains criteria such as electronic signatures, access codes, secure data files, and an audit trail which meet the requirements of 21 CFR Part 11 and help provide data integrity. IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification) protocols are included with the purchase of the OM-CP-SVP-SYSTEM Secure Software to validate that the software has been installed and is operating correctly. The layout of the secure software is similar to the OM-CP Series Data Logger Standard Software, allowing users to easily learn the additional features.
The Windows® based software package allows the user to effortlessly collect, display and analyze data. A variety of powerful tools provide the ability to examine, export, and print professional looking data with just a click of the mouse.

Logger Auto-Detection— Saves Time, Secures Data
The software automatically detects loggers as soon as they are plugged into the computer. With minimal user involvement, drivers are then installed, data is downloaded, and a graph of the data is rendered on screen.

Linked Data— Saves Time and Effort
Graphs and data grids can now be linked, allowing the user to quickly and easily modify multiple views of the same information. Make a change to the data grid and the information on the linked graph synchronizes immediately and automatically!

Multiple Data Sets— Makes Mapping a Breeze
Mapping data has never been so easy—or fast! Now data from multiple loggers can be easily combined in a single data grid by simply dragging and dropping data sets, creating a side by side comparison of data for each logger.

Software Overview— Security Settings
On the following pages are an overview of the important 21 CFR Part 11 compliance features in the OM-CP-SVP-SYSTEM Secure Software. Each feature is important in securing data and ensuring tampered data is recognized by the OM-CP-SVP-SYSTEM Secure Software.

Administrator and User Settings
Users can be given two levels of access, either administrator or user. Administrators have access to all the security settings, while users only have access to communicate with the data loggers and analyze data.

Groups
Users and Administrators can be assigned to Groups and can be easily maintained using a variety of permissions.

Login
Login attempts and lockout duration can be assigned within the Login tab. There are numerous password and account settings for the administrator to set such as the complexity of the password and status of each user account. The user management tab is only available to administrative users.

Audit Trail
An Audit Trail is kept automatically with information such as who has logged in and out, what files were downloaded, saved, printed etc. Each record is date and time stamped and includes the user information.

Electronic Signature
By clicking the Electronic Signature button, users and administrators can add electronic signatures The electronic signature contains the printed name of the signer, date and time of the signing and the meaning of the signing.

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商品説明

OM-CP-SVP-SYSTEM

¥413,490 (税込)
(税抜価格 ¥375,900)

納期: 5 週間

FDA 21 CFR Part 11 compliant IQ/OQ/PQ secure software validation workbook and software package (unlimited users, license per computer). Compatible with Windows XP/Vista/7/8 (32-bit and 64-bit). Supports all OM-CP Series Data Loggers except OM-CP-SVR101.

Ordering Example: (1) OM-CP-SVP-SYSTEM FDA 21 CFR Part 11 compliant IQ/OQ/PQ secure software validation workbook and software package (unlimited users, license per computer). Compatible with Windows XP/Vista/7/8 (32-bit and 64-bit). Supports all OM-CP Series Data Loggers except OM-CP-SVR101., ¥375,900