2. JMobile Studio includes a set of functions for responding
to the requirements specified in FDA 21 CFR Part 11.
The standard is intended to provide a solution for securely handling
electronic records and electronic signatures in industrial applications.
JMobile Studio
Audit
Signed PDF
Report
Alarm
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User Management
Security
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Development and function
4. User Management
User Group’s and user’s
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Each user must be member of one and only one group.
Each group has specific authorizations and permissions.
You can restrict access to various widgets and operations by configuring users,
user groups and assigning specific authorizations to each group.
By organizing permissions and groups you can define the
security options of a project
MAX User Group’s = 50
MAX User’s = 500
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on HMI / Runtime
5. User Management
User Management Parameter
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Parameter Description
Name Unique User name
Password
User password.
Note that for security reasons the password will never be
displayed. Passwords are encrypted and cannot be retrieved not
even for specialized technicians
Change Initial Password User is forced to change his password at first log in
Logoff / Auto log out time (minutes)
Minutes of inactivity after which the user is logged off.
Set to 0 to disable
Password minimum length Minimum length of password
Must contain special characters Password must contain at least one special character
Must contain numbers Password must contain at least one numeric digit
Must contain lower case and upper case Password must contain lower case and upper case
Password cannot be reused
The new password must be different from the last 3 used
passwords
Password aging (weeks) Number of weeks before forcing a password change (1/52 weeks)
Warning (days) Show a warning message before password expires (1/30 days)
6. User Management
Managing User at Runtime
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Action for all user
This action should be set as per
authority level/requirements
Inactive user option is available
in Edit User action
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Edit User screen
8. Alarm
Alarm with operator Acknowledgment
Operator must acknowledge alarm once trigger.
Alarm History view
Log and display alarm buffer
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Depending on HMI Model
Max 4000 alarm can be defined on HMI
& 10000 alarm can be defined on PC Runtime
MAX alarm History : 10K event/records can be stored.
10. The Audit trial/record contains information of the action executed and the user that performed them along with time stamp.
Audit Trail
Tags
Alarms
Recipe
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11. Miscellaneous
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The Audit trial/record contains information of the action executed and the user that performed them along with time stamp.
Audit Trail
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MAX Audit History : 10K event/record can be stored.
12. Electronic Signature
The user password is required before allowing the
resource to be modified by the user
Signature Validity (sec)
Password will be not required again for the next 10 Sec.
The validity time can be modified from the Settings dialog.
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Audit Trail
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13. Audit Trail
Audit View on HMI / Runtime
Tags
Alarms
Recipe
User Action
Login Attempt
failed
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System Action
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14. 14
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Trend Buffer:
Trend View on HMI / Runtime
Image of sample project:
Table View
Sample time could be 1 sec or 1/10 seconds
Graph View
15. 15
Tend Memory 50 MB TO 500 MB
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Easy to know Max Possible samples
Trend Buffer
Limitations
Depending on HMI model
Example : for 20 Tag, 5 min Sampling and Buffer size 50MB
Example : for 20 Tag, 1 min Sampling and Buffer size 500MB
Hours: 22866.66 or Days 953.77 or Years 2.61
Hours: 45748.3 or Days 1906.18 or Years 5.22
17. Signed PDF files
x.509 certificate signed from a Certificate Authority
When you open the file in Adobe Reader, it only trust certificates issued by
Adobe or one of their partners.
This means that it will show a warning if the certificate wasn't issued by
one of these authorities.
If the document has been modified, it will be highlighted with a different
message.
Valid pdf
Modified
pdf
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21. 21
Max PDF Report 64
Signed PDF Report
Log Report
Audit Report
Alarm Report
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User can define 32 pages per report.
22. 22
Signed PDF: Save Location / Storage
Signed PDF can be stored at multiple location
• USB
• SD CARD
• HMI INTERNAL
• PC location (JM PC Runtime)
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Image of sample project:
23. 23
Signed PDF : FTP Transfer to PC
Automatically:
Using HMI as FTP CLIENT we can
transfer SIGNED PDF to PC.
Need to define PC as FTP Server,
So, whenever FTP Server is available
HMI can automatically transfer file
to PC.
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Image of sample project:
