1. Home >
  2. Products >
  3. Application Example (21 CFR Part 11)

Application Example

MONITOUCH V9/X1 series : Introducing the function relevant to Part11

Key features required by 21 CFR Part 11

The main functions required by 21 CFR Part 11 or the ERES guidelines of the MHLW and the related functions of the V9 series are listed below.
21 CFR Part 11 requirements Related features of MONITOUCH V9/X1 series
An electronics signature that is legally binding equivalent of traditional handwritten signatures Extended Data Sheet
Prevention of the falsification of various data Data Logging, Alarm History, Event History
Controls for the audit trails (operation log) Operation Log
(access authority management, user identification and deletion management)
Security Component Parts

MONITOUCH V9/X1 Functions Related to 21 CFR Part 11

Electronic Signatures

PDF File Output Function (Data Sheet Function)
blank ・You can save the pre-created format to an SD card as a PDF file.
blank ・The print format can be used to display PLC values, graphs, and images.
blank ・PDF file output is page insertable, so you can save it as a single file. (an industry first) (*1)
blank ・Direct printing to the printer is also possible.

PDF File Output Function

blank ・The "Extended Data Sheet“ function is used.

Electronic Signature Function (Signed on a PDF File)
Industrial First (*1,*2)
blank ・To save a signed PDF file, sign it by hand on the screen of MONITOUCH V9/X1 and then output it as a PDF file.
blank ・This ensures that the data is stored in the same way as when it is stored in a paper form, with the handwritten signature of the individual.

Electronic Signature Function

blank ・The “Extended Data Sheet” and “Memo Pad” features are used.

*1: According to our research.
*2: X1 under development

Prevention of Data Falsification

Prevention of Data Falsification by Outputting Log Data in BIN File Format
blank ・Logging data (temperature, pressure, etc.) and alarm history stored in MONITOUCH V9/X1 can be saved in the BIN file format (*2) in an SD card or a USB thumb drive.
blank ・The contents of the data cannot be easily viewed or altered because the data is in the BIN file format.

Prevention of Data Falsification by Outputting Log Data in BIN File Format

Applicable MONITOUCH V9/X1 features: Data Logging, Alarm History, Event History

*2: To convert the BIN file to a CSV file, a dedicated tool is required.

Controls for Audit Trails (Operation Log)

Operation Log Function
blank ・Operations such as on-screen push-button operations and numerical input are recorded in chronological order.
blank ・You can refer to the history of who/when/what/how the operation was performed. It is useful for analyzing the cause of abnormalities.

operation log

blank ・The operation log files stored in the storage can be converted to CSV files using the dedicated tool "LogToCSV".


* This function uses the "Security Component Parts" of MONITOUCH V9/X1.
Controls for Passwords
blank User IDs/Passwords Registration Using MONITOUCH
blank ・You can easily register/change/delete user IDs or passwords with MONITOUCH V9/X1 without preparing a computer if you log in to MONITOUCH V9/X1 as an "Administrator".
blank ・In addition, the administrator authentication allows you to refer to "Login History" and "Unauthorized Access History" and change the administrator's password.

Controls for Passwords

blank ・Password Conditions:
blank - 8 to 16 characters in length, using one-byte alphanumeric characters and symbols.
- Case sensitive
- All types of uppercase letters, lowercase letters, and numbers must be used.

blank Controls for Security Levels
blank ・Security levels can be set for each user ID. Functional restrictions are applied according to the level.
blank ・It is possible to interlock buttons and hide parts on the screen depending on the security level.
The priority of operable buttons and displayable data is configurable for each security level.
Controls for Security Levels
blank Controls for Password Expiration
blank ・You can manage the expiration date of the passwords.
blank ・Once the password expires, the user will not be able to login until the user changes his/her password.

Controls for Password Expiratio

Auto Logout Function/Unauthorized Logins Prevention
blank Auto Logout Function
blank ・You can set the system to automatically log out of the system when there is no screen activity within a set time.
blank ・This prevents unauthorized access to the site.

Auto Logout Function

blank Prevention of Unauthorized Login
blank ・If successive password mistakes are made, the registered user‘s settings will be disabled and the user will not be able to login.
blank ・The administrator can re-enable the disabled user's password by setting it to “Valid” in the User Login Settings screen.

Prevention of Unauthorized Login

List: Functions of the Security Component Parts

Functions What the Security Component Parts can do
Number of available users 50 entries
Restrictions on Password Setting The password must be:
・between 8 and 16 characters long in one-byte alphanumeric characters and symbols.
・including all types of uppercase letters, lowercase letters, and numbers.
Restrictions on the use of passwords Use of the last 10 passwords per user prohibited-
Password change function User configurable
Security levels 0 through 15 (16 levels)
Password expiration date 0 through 65,535 days (Warning message 7 days before expiry)
Number of password errors 0 through 65,535 times
Wrong password handling Selectable as “Valid” or “Invalid”
Auto-logout function 1 through 540 minutes
Log display Login user history and unauthorized access history

〈IMPORTANT〉 Appropriate System Architecture and Operation

This document explains some of the features of MONITOUCH V9/X1 that are relevant to 21 CFR Part 11.
However, in order for your system to comply with Part 11, you will need to build and operate a suitable system.