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This User Manual has been translated for your
convenience using machine translation. Reasonable
efforts have been made to provide an accurate
translation; however, no automated translation
is perfect nor is it intended to replace human
translators. The official User Manual is the English
version. Any discrepancies or differences created in
the translation are not binding and have no legal
effect for compliance or enforcement purposes. If
any questions arise related to the accuracy of the
information contained in the User Manual, please
refer to the English version of those contents which
is the official version.
1. General Introduction
1.1 Introduction
This software is a recorder data management software
specially developed for users, with various characteristic
functions and simple operation. This software not only
provides graphs, tables and other intuitive forms of data
statistics, and can export a variety of format files for
preservation, but also can record and screen data, it is very
convenient for individuals to view the data of recorder
device ,also for enterprise and department to manage all
kinds of devices data.
1.2 Performance
This software has good security and confidentiality, and it
is convenient to use.
1.3 Functions
Main functions:
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(1) Read data; (2) Upload data; (3) Query historical data;
(4) Parameter configuration; (5) Graphs and tables; (6)
Statistical device information; (7) Signature; (8) Import and
export for data; (9) Email.
2. Installation and Startup
2.1 Operating Environment
This software must run with Windows 7 or above version
of the operating system, and the operating system must
be installed.NET Framework 4.6 or above version of the
operating environment.
2.2 Installation
Double click to open the software installation package,
enter the installation wizard window, and click „Next", as
shown below:
Select the installation path of the software in the window
that appears, and click „Next", as shown below:
Click „Install" in the pop up window to start installing the
software, as shown below:
Click „Finish" after the installation, as shown below:
2.3 Startup
After the installation is finished, the default is the offline
version (no login mode). FDA21 CFR Part 11 module needs
to be enabled to use all functions of the software.
What is FDA 21 CFR Part 11 compliance?
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Rev. 02.04.2019
The United States Food and Drug Administration (FDA)
promulgated the federal regulatory code, chapter 21, Part
11 (21 CFR Part 11) in 1997, and issued industry guidelines
in 2003 to refine the rules. In the 21 CFR Part 11 regulations,
electronic records are considered to have the same effect
as written records and handwritten signatures and are
applicable to any records created, modified, maintained,
archived, retrieved, transmitted or stored in a persistent
storage medium governed by existing FDA rules.
21 CFR Part 11 is widely accepted and implemented by
biomedical enterprises, hospitals, research institutes and
laboratories in the United States. Since the promulgation
has been promoted to the world, although not mandatory,
but by Europe, Asia and other countries generally accepted
and used. Any drug, biomedical device or information system
exported to the United States shall comply with 21 CFR Part
11. In case of violation, the FDA will, in accordance with the
regulations, deprive the export right to the United States.
Specific operations to enable 21 CFR Part 11 are as follows:
After the installation is finished, open the software, click the
„System" button, and select „FDA21 CFR Part 11 module",
and choose „Start FDA21 CFR Part 11 module", finally click
„Yes" to restart the software in the pop up window to unlock
all functions of the software. The following is a full function
model to describe the use of the software.
3. Login Modes
3.1 Local Computer
Click the „Mode" button in the login interface to enter the
configuration interface of login modes. The system defaults
to the local computer mode, after choosing this mode, all
the user's data will be saved on the local computer and it
can be operated by self.
3.2 Remote Cloud Server
Click the „Mode" button in the login interface to enter the
configuration interface. Select the Remote Cloud Server
Mode and click „Save" to enter it. If there is local user
information, click „Save" to remind you whether to upload
local user information and click „Yes". As shown below:
Rev. 02.04.2019
4. Registration
4.1 Administrator Registration
Click „Register" at the bottom right of the login interface,
and then fill in the corresponding information. After
finished, submit and save it. Finally, a pop up shows that
the registration has been successfully saved, as shown in
the figure below:
4.2 Add User
Login administrator account, click „System „, choose „FDA21
CFR Part 11 module", then click „configure FDA21 CFR Part
11 module" in the lower left, and then, choose user account,
click „Add User", fill in the corresponding information and
click „Save" to add successfully.Regular users belonging
to the same company need to be authorized by the
administrator to log in. The operation interface is shown in
the following figure:
5. Data Management
5.1 Reading Data
The software can obtain data from the recorder device in a
very simple way. The software will automatically detect the
device and read the data. All it needs is to connect the data
recorder device to the computer, as shown below:
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