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Secure Software for Use with OM-CP Series Data Loggers
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USD$66,685.00
OM-CP-SVP-SYSTEM
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Install, Validate and Operate One Software Program Universally
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Compatible with Most OM-CP Series Data Loggers
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Time and Cost Saving Validation Package–Stands up to Interrogation from Auditors
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Automatic Data Security and Audit Trail
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Sophisticated User Maintenance
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Traceability with Customizable Electronic Signatures and Audit Trails
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Aids in Compliance with FDA 21 CFR Part 11/820 and GxP Guidelines
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Applications: Pharmaceutical, Medical, Hospitals, FDA Regulated Organizations, Temperature Mapping
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View related products - Data Acquisition and Analysis Software
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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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† All dollar amounts on this site are shown in US currency.
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., USD$66,685.00
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