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Data Management Software
User Manual
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Table of Contents
I Introduction................................................ .................................................. ............. 1
1.1 Overview................................................ .................................................. ......... 1
1.2 Installation environment requirements................................................ ...1
II Install & Start .................................................. .................................................. ... 2
2.1 Install................................................ .................................................. ........... 2
2.2 Start .................................................. .................................................. ............. 4
2.3 Uninstall .................................................. .................................................. ..... 4
III Functions .................................................. .................................................. ............. 5
3.1 Toolbar................................................ .................................................. ........... 5
IV Download Data................................................. .................................................. .......... 6
4.1 Connect data logger................................................ .......................................6
4.2 Read data................................................. .................................................. ........ 6
4.3 Store data................................................. .................................................. ......6
V Summary................................................ .................................................. ....................... 7
5.1 Device information................................................. .......................................7
5.2 Statistical information................................................ ................................7
5.3 Alarm information................................................. ............................................8
VI Parameter Settings................................................. .................................................. 9
6.1 Device parameters................................................ ............................................9
6.2 Alarm parameters................................................ ............................................9
6.3 Parameter template................................................... ....................................10
VII Summary................................................ .................................................. ................. 11
7.1 Graph ................................................ .................................................. ............. 11
7.2 Table .................................................. .................................................. ........... 12
7.4 Data filtering ................................................. ................................................13
7.5 Export data................................................. .................................................. .. 13
VIII Database................................................ .................................................. ............. 15
8.1 Historical data table ................................................ ...................................15
8.2 Filter data................................................. .................................................. .. 15
8.3 Select data line................................................ ............................................16
8.4 View details................................................. .................................................. 16
8.5 Display alarm data................................................ .......................................17
8.6 Delete data................................................. .................................................. .. 18
IX System Settings................................................. .................................................. .... 19
9.1 Options................................................ .................................................. ......... 19
X FDA 21 CFR Part 11 Module................................................... .......................................20
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10.1 What is FDA 21 CFR Part 11 complianceÿ.............................................. .20
10.2 Access to the Module................................................. ...................................20
10.3 Activate the Module................................................ ...................................21
10.4 Initializing Administrator................................................ ....................22
10.5 User Management................................................ ............................................23
10.6 Rights Management ................................................ ....................................24
10.7 Meaning Management................................................ ...................................25
10.8 Security Policy................................................ ............................................26 10.9
User Login.... .................................................. ............................................ 27 10.10
Electronic Signature. .................................................. ...........................28
10.11 Audit Trail ................................................ ................................................30
XI Q & A.............................................. .................................................. ......................... 31
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I Introduction
1.1 Overview
Data Management Software is comprehensive desktop software designed for
analyzing and managing the temperature and humidity data recorded by Elitech data
loggers.
The software integrates the most dependable temperature and humidity sensing
technology and the most advanced system kernel to date. It is characterized by reliable
data, quick response, simple operation and other strong functions, enabling users to track
and collect temperature and humidity data of sensitive products timely and accurately in
their testing, production, transportation and storage, so that the whole cold chain can be
monitored and traced with product safety guaranteed.
1.2 Installation environment requirements
Pentium 1GHz or above, 2G or more
A hard drive with 1GB available disk space
Windows 7 / 8 / 10
Mouse or other pointing device
A VGA monitor with display resolution 1440 x 900 pixels or better
Computer administrator account
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II Install & Start
2.1 Install
1) Double click installer to start installation.
2) Select destination location.
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3) Click Install.
4) Click Finish and installation completes.
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2.2 Start
Double click on your computer desktop to start the software.
2.3 Uninstall
1) Open Windows start menu, find this software.
2) Right click Uninstall to enter Add or Remove Programs.
3) click Uninstall.
4) Wait until uninstallation completes.
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III Functions
3.1 Toolbar
Summary: After successfully downloading the data, the software will show the logger'
s basic information, statistics and alarm status.
Setting: Users can set the parameters of a connected data logger, including log interval,
start delay, trip code, trip description and alarm settings.
Database: The data downloaded from the logger is automatically saved to the database,
so users can view the data anytime. Data can also be filtered as needed. Default
display is latest one month's data. Users can also view data of a selected
time range, filter alarm data, drag and select multiple lines of data. The
Data from multiple devices can be viewed and compared at the same time. Item
supports multi-graph drawing, parameter comparison and other functions.
21 CFR: FDA 21 CFR Part 11 Function.
Preferences: Include three tabs: Option (to change date/time format and language), Email
settings (to set email parameters) and FDA 21 CFR Part 11 Module (to enable and configure
the module).
Help: User Manual.
About: About us.
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IV Download Data
4.1 Connect data logger
Connect the data logger to a computer for downloading data. Only one logger can be
connected to the software at a time. It does not support simultaneous operation of
multiple loggers.
4.2 Read data
Click Download on the toolbar to read and download the data in the logger. If the data
logger is connected for the first time, the software will automatically read and download
the data.
4.3 Store data
After downloaded, the data will be saved to the database automatically. The data can
be viewed in "Database" interface.
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V Summary
5.1 Device information
S/N: The unique ID of the data logger. It cannot be changed.
Log interval: The interval time between two successive data points.
Device status: The current working status of the logger.
Trip code: User-created code, used to identify each task.
Trip description: A brief description of the task.
Start delay: The time from the logger started to the first point saved.
Start mode: The mode the logger to be started, including manual start, timing start,
immediate start.
Software version number: The logger's internal program version number.
Repeated start: The logger is started repeatedly, and the previously recorded data is
cleared after a new startup.
Allow pause: During recording, temperature/humidity collection and storage is
suspended.
Temporary report: Whether the PDF report is allowed to be generated after the logger
is inserted into the computer during recording.
5.2 Statistical information
Memory capacity: Maximum amount of data points the logger can save.
Data points: The amount of readings the software downloads from the logger.
Start time: The time when the logger starts running.
First record time: The time when the first point is recorded.
Last record time: The time when the last point is recorded.
MKT: Average kinetic temperature value.
Elapsed time: The total time that the logger keeps recording.
Stop mode: The logger's current stop mode, including temporary stop, stop via software,
manual stop.
Stop mode: The set stop mode, including stop via software, manual stop.
Max: The maximum value among the recorded temperature and humidity readings.
Min: The minimum value among the recorded temperature and humidity readings.
Avg: The average value of the recorded temperature and humidity readings.
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Initial alarm: The recorded time when the first out-of-limit alarm is triggered.
5.3 Alarm information
Alarm value: The alarm set-point of the logger (temperature / humidity)
Alarm delay: If the specified time when the measured temperature exceeds the alarm
set-point elapses, the alarm will be triggered.
Alarm type: The set alarm type of the logger (single / cumulative).
Overrun time: The cumulative time of out-of-limits readings.
Overrun times: The number of out-of-limits readings.
Status: The status of the logger in each alarm zone.
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VI Parameter Settings
6.1 Device parameters
S/N: The unique code of the logger. It cannot be changed.
Log interval: The interval time between two successive data points. It can be
configured per day or time.
Trip code: User-created code, used to identify each task.
Trip description: A brief description of the task. 100 alphabetic and numerical characters.
Start mode: The mode the logger to be started, including manual start, timing start,
immediate start. When timing start is set, start time choice box is available.
Start delay: The wait time from the logger started to the first reading saved. When manual
start is selected, start delay choice box is available.
Timing start: The logger starts running at the specified time. When timing start is
selected, timing start selection box is available.
Stop mode: The way that the logger is stopped: manually, or via software.
Repeated start: The logger is started repeatedly, and the previously recorded data is
cleared after a new startup.
Allow pause: During recording, the temperature and humidity collection and storage are
suspended.
Temporary report: Whether the PDF report is allowed to be generated after the logger
is inserted into the computer during recording.
Cyclic Record: When the data memory is full new data automatically replaces the oldest
readings.
PDF language: The PDF report generated is in English / Chinese.
Temperature unit: Celsius / Fahrenheit.
6.2 Alarm parameters
Alarm mode: No alarm, high / low limit alarm, more high / low limit alarm zones optional.
~
Alarm value: Alarm set-point; temperature range: -40ÿ~ 90ÿ; humidity range: 0% 100%.
Alarm type: Single / cumulative.
Single type: Temperature/Humidity is above or below the alarm threshold and its duration
is not less than the alarm delay, alarm will be triggered.
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Cumulative type: Temperature/Humidity is above or below the alarm threshold and its
cumulative time is not less than the alarm delay, alarm will be triggered.
Alarm delay: The time when temperature / humidity value exceeds the alarm set-point until
the alarm event is triggered.
6.3 Parameter template
Export template: The parameter values in current page are saved as a file.
Import template: Reads the specified parameter template file and loads the parameter
values in the file into the interface.
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VII Summary
7.1 Graph
Click the "Graph" tab to display currently selected data of the logger. It can be the
data of a currently connected logger or the historical data stored in the database. 10
data curves can be displayed at the same time for users to compare the temperature and
humidity changes. The Y-axis on the left side of the graph shows the temperature scale
value and the right Y-axis shows the humidity scale value. The X-axis shows the logger's
time or reading's No.
Toolbar: The graph supports zoom and drag functions, allowing the user to zoom in, zoom
out, and drag the curve by clicking the button in the upper left corner. The curve can
be restored to its original state at any time after operation.
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7.2 Table
Click the "Table" tab to display currently selected data of the logger. It can be the
data of a currently connected logger or the historical data stored in the database. Data
from multiple devices can be viewed for comparison. Normal temperature and humidity data
is marked in black, overrun value in red, and USB value in gray.
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7.4 Data filtering
Click the "Filter Data" button at the bottom left. Select "Start time" and "End time",
and click "OK", the software will automatically filter the data within specified time
period. After data filtered, the software will automatically redraw the graph, table,
and summary.
7.5 Export data
Click the "Export Data" button at the bottom left to export report to PDF, Excel and
ESF (custom format) format.
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VIII Database
8.1 Historical data table
Click Database on the toolbar to query historical data. The data downloaded from the
logger is automatically saved to the database and can be filtered as needed. Default
display is the latest month's data. Users can also view data of a selected time range,
filter alarm data, drag and select multiple lines of data. The data of multiple devices
can be viewed and compared at the same time. It supports multi-graph drawing, parameters
comparison and other functions.
8.2 Data filter
Select the time range in certain month(s), the software will automatically filters out
the historical data for that time period and displays the data in the table.
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8.3 Select data line
Click the first column on the left side of the data table to select the data line.
It is used to view the record or delete the selected data line.
8.4 View details
Click the "View details" button in the right sidebar to view the data details in graph,
table or summary.
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8.5 Display alarm data
Check “Alarm” in the right sidebar to view only the data of the alarmed device.
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8.6 Delete data
First click on the blank in the first column on the left side of the data table to select
the data to be deleted. Then click the "Delete" button on the right sidebar, the software
will prompt the user "whether to delete the data." After confirmed, the data will be
deleted and cannot be recovered.
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IX System Settings
9.1 Options
Click “Preferences” on the toolbar to set the date/time format and language. Then click
"Save", the latest date and time format will be automatically updated for your use next
time.
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X FDA 21 CFR Part 11 Module
10.1 What is FDA 21 CFR Part 11 complianceÿ
The United States Food and Drug Administration (FDA) issued regulations Title 21 Code of
Federal Regulations Part 11 in 1997 and enacted relevant industry guidelines in 2003 to
refine the rules. It provides criteria for acceptance of electronic records, signatures, and
handwritten signatures executed to electronic records as equivalent to paper records and
handwritten signatures executed on paper. Part 11 applies to any record governed by an
existing FDA predicate rule that is created, modified, maintained, archived, retrieved, or
transmitted using computers and/or saved on durable storage media.
FDA 21 CFR Part 11 is widely accepted and implemented by biomedical companies,
hospitals, research institutes and laboratories in the United States. Since issued, it has
spread around the world. Although not mandatory, it is generally accepted and used in
Europe and Asia. Any pharmaceuticals, biomedical related equipment, or information
systems exported to the United States should comply with 21 CFR Part 11 regulations,
which if violated, can deprive the exporter by the FDA of its right to sell goods to the United
States.
10.2 Access to the Module
Click "System" on the toolbar and then click the tab FDA 21 CFR Part 11 Module.
Note: 21 CFR Part 11 module is not a default function ready for use after software
installation. You need to enable this module by going to System > FDA 21 CFR Part 11
Module. The interface gives a brief introduction to the
module.
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10.3 Activate the Module
Check “FDA 21 CFR 11 Module” to activate the module. After FDA 21 CFR 11 module
is enabled, program will restart for the changes to take effect. Click Yes.
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10.4 Initializing Administrator
After FDA 21 CFR Part 11 module enabled, you are required to create an administrator
account for login.
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10.5 User Management
Administrator account can be used to create user accounts, change user info, lock/unlock
user and reset passwords.
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10.6 Rights Management
System Right
Administrator owns all system rights.
User right is granted or revoked by administrator.
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10.7 Meaning Management
To sign electronically, user must select a meaning, which will be linked
to the data record.
New Meaning:
Enter meaning name, click Save or Enter, the meaning will be saved to
database.
Available Meanings: All
meanings are listed.
Meanings:
User meanings are managed by Administrator.
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10.8 Security Policy
Login attempts: If
login attempts exceed the set times, the account will be locked. Please
contact administrator to unlock the account.
Login protection:
If the system stays inactive after login for a period that exceeds the set time, it will be locked.
User must log in again to operate the system.
Password expiration date:
This setting indicates the password is valid before a certain period of time.
If the password expires, the system will remind the user of changing it 3 days earlier.
Reminder: 0 indicates that this setting is disabled.
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10.9 User Login
If FDA 21 CFR Part 11 module is enabled, user must log in to enter the system.
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10.10 Electronic Signature
After the data logger is connected to a computer and its data is downloaded to the database
successfully, you may click "Graph" icon in the toolbar and then "Electronic Signature" to
sign. Enter the user name and password in the popup interface as follows:
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After signature authorization, please select one meaning as follows:
Then click OK. The system will sign and pop up "Signature success". Then you may click
the tab "Signature" under "Graph" to view signature
information.
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10.11 Audit Trail
Audit trail records user's operations of the system, including time, actions, etc. The data can be filtered by time, audit type, action
type and user
yam.
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XI Q & A
1. The data logger cannot be connected?
Check if the computer USB port is available. If you are using a USB
extension cable to connect the logger, make sure that USB can be read.
If the cable is too long, the logger may not be connected successfully.
2. After the logger inserted, the software will pop up a prompt to enter
password?
After the logger is connected to the computer, the software will automatically read the data from the
logger. If the password is configured before the logger is started, the software will pop up a prompt to
enter the password. If the password is forgotten, please check with the
administrator who configured the logger.
3. It always prompts error when saving the data?
Check if the computer's disk space where the software is installed runs
out.
4. Mail is not sent successfully when mailbox parameters have been set? a) Please open the "System"
interface, double check if the mail parameters are set correctly, including whether the SMTP address
and port is consistent with that of the mailbox service provider. Please open your
mail to check whether the mailbox service provider opened the SMTP service.
If not, please contact your mail service provider to make sure you can use the SMTP service. If the
SMTP configuration is incorrect, the mail cannot be sent.
b) Please check whether you entered a correct email account and password.
The email cannot be sent from a wrong account.
c) If the mail parameters are confirmed correct, click “test mailbox”
to make sure the mail can be sent.
5. The data cannot be read after the logger connected?
The logger is connected, but the software cannot read the data. Please
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check whether the status bar shows the logger model. If not, the logger
is connected incorrectly. Please check whether the USB port is available
or the cable is available. If OK, please check if the logger is damaged.
6.The software cannot be installed normally?
Please check whether the disk space where the software is installed runs
out.
7. Errors always occur when the data is being read?
Please check if the USB port is loose and the cable is too long.
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Version Log
Version Date Description
V1.0 2017-06-19 The first version.
V1.1 2017-07-31 Add LogEt, RC-5+.
V2.0 2017-12-12 Add FDA function.
V3.0 2018-03-26 FDA audit passed.
V3.3.0 2018-09-28 Increase GSP8, LogEt8TE and LogEt8TH support.
Modify humidity data to display wrong BUG.
V3.3.1 2018-10-26
Replace LOG pictures.
Modify RC4HC humidity data unit to display no
V3.3.2 2018-12-25
temperature error
Support LogET1 Series Recorder
V4.0.0 2019-03-01 Support LogET8 Series Recorder
Automatic update of new programs
1.Tlog adds repeat start and stop function
V4.3.0 2019-11-05 2.Enhance GSP-8A functionality
3.Fixed some bugs
V4.4.0 2020-01-19 Fixed some bugs
Modify the low voltage display range, modify the
V4.5.0 2020-02-26
current points and read points of the COM port
V5.0.0 2020-04-28 Added the function of uploading data to the cloud
Increase industry application functions.
V5.0.2 2020-08-06
Brand segmentation.
V6.0.0 2020-09-27 Add automatic upgrade function
Increase RC-17, RC-17N.
V6.0.2 2021-04-16
Fix some bugs.
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GSP-6 and GSP-6G increase display minimum and
V6.0.3 2021-05-24
maximum function
V7.0.0 2022-03-15 New UI release
V7.0.1 2022-07-30 New UI function optimization and upgrade
1.Add some new functions
V7.2.0 2023-12-25
2.Optimize some functions
1.Support for reading shadow data function
V7.2.1 2024-02-05
2.Optimize some functions
1.German and French added to software languages
V7.2.2 2024-05-20 2.Support elt file import
3.Optimize some functions
1.Support GSP-6Pro model
2.Support for exporting elt files
3.Add data printing function and audit log export
V7.2.3 2024-09-29
function
4.FDA Functional Upgrades and Certifications
5. Optimize some functions
V7.2.4 2024-10-12 1. Optimize some functions
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