SOP-002: E2B Configuration

DOCUMENT CONTROL

Field	Value
SOP ID	SOP-002
Version	1.0
Status	Active

INFO

Document Control

Document Title: E2B Configuration Document Version: 1.0 Effective Date: January 1, 2023 Author: John Doe

Purpose

This Standard Operating Procedure (SOP) provides detailed instructions for configuring the E2B system settings. The E2B (Electronic Transmission of Individual Case Safety Reports) is a standard for the electronic transmission of Individual Case Safety Reports (ICSRs) between regulatory authorities and pharmaceutical companies.

Procedure Flowchart

┌───────────────────────────────────────────────────┐
│                 E2B Configuration                 │
└───────────────────────────────────────────────────┘
     ┌───────────────────────────────────────────┐
     │ 1. Access the E2B System Administration   │
     └───────────────────────────────────────────┘
           ┌───────────────────────────────────┐
           │ 2. Configure E2B System Settings  │
           └───────────────────────────────────┘
                 ┌───────────────────────┐
                 │ 3. Verify Configuration│
                 └───────────────────────┘
                       ┌───────────┐
                       │ Complete  │
                       └───────────┘

Step-by-Step Procedure

1. Access the E2B System Administration

Log in to the E2B system with an account that has administrative privileges.
Navigate to the "System Administration" section of the E2B application.

WARNING

Ensure that you have the necessary permissions to access the System Administration module.

2. Configure E2B System Settings

General Settings:
- Set the E2B reporting standard version (e.g., R2, R3).
- Configure the organization's contact information, including name, address, and phone number.
- Specify the default language for the system.
User Management:
- Add new user accounts with appropriate roles and permissions.
- Manage user profiles, including password policies and user status (active/inactive).

Transmission Settings:

Configure the incoming and outgoing E2B transmission settings, including file paths, email notifications, and transmission protocols (e.g., SMTP, FTP, SFTP).

python

# Example configuration for SFTP transmission
transmission_settings = {
    "incoming": {
        "protocol": "sftp",
        "host": "sftp.example.com",
        "port": 22,
        "username": "e2b_user",
        "password": "secret_password",
        "remote_path": "/incoming/e2b"
    },
    "outgoing": {
        "protocol": "sftp",
        "host": "sftp.example.com",
        "port": 22,
        "username": "e2b_user",
        "password": "secret_password",
        "remote_path": "/outgoing/e2b"
    }
}

Data Mapping:
- Configure the mapping between internal data fields and the E2B data elements.
- Ensure that the mapping is compliant with the E2B reporting standard.
Business Rules:
- Define the business rules for data validation, processing, and routing of E2B reports.
- Customize the rules based on your organization's requirements and regulatory guidelines.

3. Verify Configuration

WARNING

It is recommended to thoroughly test the E2B configuration using sample data before deploying to the production environment.

[ ] Verify that all the general settings are correctly configured.
[ ] Ensure that user accounts and permissions are set up as expected.
[ ] Test the incoming and outgoing E2B transmission settings by sending and receiving sample E2B files.
[ ] Validate the data mapping between internal and E2B data elements.
[ ] Confirm that the business rules are functioning as intended.

Troubleshooting

Issue	Possible Cause	Resolution
Unable to access the System Administration module	Insufficient user permissions	Verify that the user account has the necessary administrative privileges to access the System Administration module.
E2B transmission failure	Incorrect transmission settings	Review the transmission settings, including the protocol, host, port, username, and password. Ensure that the information is accurate and the connection is working.
Data mapping issues	Incorrect mapping configuration	Review the data mapping settings and ensure that the internal data fields are correctly mapped to the E2B data elements.
Business rule violations	Incorrect rule configuration	Revisit the business rule settings and make sure that the rules are defined correctly based on your organization's requirements and regulatory guidelines.

DANGER

If you are unable to resolve the issue after following the troubleshooting steps, please contact the E2B system support team for further assistance.

SOP-002: E2B Configuration ​

Purpose ​

Procedure Flowchart ​

Step-by-Step Procedure ​

1. Access the E2B System Administration ​

2. Configure E2B System Settings ​

3. Verify Configuration ​

Troubleshooting ​

See Also ​