FDA 21 CFR Part 11 standard

This software is designed and implemented in strict accordance with FDA 21 CFR Part 11 standards and GMP standards to meet the special needs of specific industries.

Function description: The specific functions are introduced in 5 major aspects.
1. Access Control
2. Permission Classification
3.Data Security
4. Digital Signature
5.Audit Trail


Part I  Access Control
Access control includes two functions: user restriction and user management.

A)User restriction: Only authorized users are allowed to use the software to prevent unauthorized users from illegally using the software. To effectively limit the number of people using the software to ensure data security.

All personnel who use the software must first log in to the software and enter the correct user name and password to enter the software. Unauthorized users, or users who cannot accurately enter their user names and passwords, cannot use the software. After entering the software, different users perform operations that are specific and permitted by their permissions.
 

2. User management: The software has a super administrator by default, and the default user name and password are both: admin. The super administrator has the highest authority, cannot be deleted, and has all authority. And the user name of the super administrator cannot be changed, but the password can be changed. When the instrument manager uses it for the first time, it is necessary to change the default password to ensure the security of the software. The super administrator manages the software users through the user management function.

The user management interface is as follows
User management responsibilities include adding accounts, account editing, deleting accounts, password control, authority editing, unlocking and other six functions.

1. Add account: Create an account with a lower authority level than the current login account, and users at the same level have the same functional authority.
2. Account Editing: Only accounts with lower privileges can be edited, and the information of the selected account can be edited, including opening or closing, password reset and other information.
3. Delete Account: Delete accounts that are no longer in use.
4. Password control: Edit the relevant specifications of password usage, including password life, password length and password lock and unlock conditions.
5. Permission Editing: Edit the operation permissions corresponding to different permission levels.

6)Unlock: Unlock the selected user.

Part II  Permission Classification

Permission Classification includes two functions: user restriction and user management.

A) Account classification: The software account adopts three levels of authority, the first level is super administrator, the second level is administrator, and the third level is ordinary account. Among them, ordinary accounts are also divided into different levels according to the different functional permissions set at the time of creation. How many levels are divided into, and what function permissions are set for each level, are determined by the authority allocation. The three levels of authority are described in detail below.

Super Admin:

1. With all permissions.

2. Create and manage administrator and general accounts.

3. Change the password and cannot be deleted.


Administrator:

1. Create ordinary accounts of different levels.

2. Modify ordinary accounts of different levels.

3. Set the functional authority of ordinary accounts of different levels, and edit the authority.

4. Delete ordinary accounts of different levels.

5. Reset the passwords of ordinary accounts of different levels.

6. Turn on or off the file protection function.

7. Use all functions of the software.

8. View, retrieve or export audit trail logs for all common accounts and current accounts.

9. Backup or replace the audit trail log database.
 
It should be noted that administrators cannot create, modify or delete administrator and super administrator accounts. Otherwise has all permissions. The super administrator can set up several administrators to carry out all the daily management of software and instruments. The administrator sets different authority levels and creates common accounts of different levels to carry out specific management work.


Ordinary account:

1. Log in to use the software.

2. Function authority set by the administrator.

3. Change the password.

4. View, retrieve or export the audit trail log for the current account.

5. View the data files created by the current account.


B)Privilege assignment: set different common user levels, and set specific permissions for common users of different levels. As for setting several levels of users and which permissions are set for each level of users, the administrator will set them according to the company's specific management requirements, and assign different usage permissions to different levels of staff to meet management requirements. The interface is as follows.

Different levels have different permissions, and multiple users can be created at the same level, but they all have the same permissions, but the user names or passwords are different. Username and password need to be kept by yourself.
Part III Data Security

Data security is protected through the following three aspects.

1. Software login: After the audit trail function is enabled, you need to log in every time you use the software, and enter the correct user name and password to enter the system and use the software. Prevent illegal use of software by unauthorized personnel.

2. Overtime login protection: Set an interval time, when the time away from the computer reaches this time limit, the software will automatically lock, and you need to re-enter the correct user name and password to log in. Prevent unauthorized personnel from illegally operating data during the time when the user temporarily leaves during operation. This feature can be turned on or off. If the set time is 0 minutes, the function is turned off.

3. File protection:

a. Ordinary users can only open digitally signed data files saved by themselves.
b. The administrator can open the data files saved by himself and the files saved by any other ordinary users.
c. Administrators cannot open each other's digitally signed data files.
d. The data can only be opened, viewed and deleted through the software, and the data cannot be operated externally.
e. Ordinary users cannot delete, backup or export saved data.
f. The administrator can delete, backup or export the saved data.


Through the above measures, the security of each user's personal data and the absolute viewing authority of the administrator are guaranteed. After the data is saved, the possibility of illegal copying of the data by outsiders is eliminated. The data can only be manipulated and modified through the software only way.

This feature can be turned on or off. Only the administrator has the right to open or close the operation. After enabling file protection, the specific situation is as follows.

Administrator privileges are as follows,

a. You can open external files and protected files.
b. You can save the data as an external file, or you can save the data as a protected file.
c. You can view, delete, and back up all protected files.
d. You can open or close the file protection function. Ordinary accounts have only limited permissions, and the permissions are as follows:

a) External files and protected files of this account can be opened.
b) Data can only be saved as protected files.
c) You can only view the protected files saved by yourself, you cannot view the files saved by other users, you cannot back up data, and you cannot delete any protected files.


Part IV Digital Signature

In order to ensure that the data or files used have reliable sources, it is necessary to ensure that the data or files have corresponding operators. Digital signatures guarantee that data or documents are associated with the relevant operator.
 
2. File record: While performing various processing and modification on file data through this software, these operation information
When the file is saved, the information is saved together and can be viewed at any time. There are corresponding records of who and when a file has been processed. The person who performs the operation is responsible for the data after the operation.
All processing, each link has a corresponding responsible person, which effectively ensures the safety of the whole process, so the files with digital signatures are relatively safe to use.

Data processing information can be viewed through the menu: Information/View----Register Information.

Part V Audit Trail

In order to monitor and manage the usage of the software, during the running of the software, all valuable operational information will be saved in the database and files in the form of logs, so that the administrator can keep abreast of the usage of the software.

System Tracking: During the running of the software, the operation information is saved in the form of logs, whether it is the parameter setting of the software, the modification of the file, or even the user information logged into the system, so that the administrator can view it in the future , to understand the usage of the software by all users.

Log viewing: Administrators can view all log information, or search for logs with specified conditions to view. Ordinary accounts can only view the operation logs of themselves and accounts with lower permissions. Through the viewing function of the log, it can play a role of supervision and management, as well as the function of archiving and verification in the future.



File tracking: During the process of data file processing, all necessary operation information will be saved along with the data file, and can be added next time it is opened, and can be viewed at any time. The file tracking records every link in detail, the information of all operators who have operated on the data, and the relevant responsible persons are clarified to ensure the security of the data files.

Audit trail: It is a very important function that can record each user: when the software is used, what operations and settings have been performed on the software, which files have been processed, what modifications have been made to the files, and so on. It provides a detailed basis for the review of software usage in the future. The log viewing interface is shown in the figure below.
The "Clear" record button is only available after the log record is saved.