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Oracle® Health Sciences Pharmacovigilance Operational Analytics User and Administrator Guide Release 1.0 E23554-01 |
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# 7 Implementing Security

This chapter contains the following topics:

- About Security in Oracle Health Sciences Pharmacovigilance Operational Analytics

- Setting Up User Authentication

## 7.1 About Security in Oracle Health Sciences Pharmacovigilance Operational Analytics

Oracle Health Sciences Pharmacovigilance Operational Analytics (OPVA) spans several applications:

Oracle Argus Safety is the data source.

Informatica ETL Execution plans and transforms Oracle Argus Safety data structures into the star schemas required by Oracle Business Intelligence Enterprise Edition (OBIEE).

OBIEE reads from the star schemas and provides the user interface, where end-users can view and analyze data through dashboards and reports.

OPVA security includes:

- Authentication OPVA user accounts are maintained in WLS Embedded LDAP. A customer who is using OAM to authenticate the source system access can also configure it for OBIEE authentication.

- Authorization You assign user accounts to user groups in WLS Embedded LDAP. On login, OBIEE ascertains the authenticated user's user group, where user groups with the same name determine which parts of OPVA the user can use.

  Predefined OBIEE user groups determine the privileges allowed to users and allow access to the shipped OPVA dashboards and reports. You can create additional user groups as needed in OBIEE.

- Data Access In OPVA, access is also performed at row level. This is done by extracting the access records for studies, products and sites from the source system.

### 7.1.1 Example

This section describes how to set up security for the following basic types of users as an example.

- OPVA End Users are people who can view Oracle Argus Safety data in OPVA through dashboards and reports. The specific dashboards and reports they can view is determined by the user groups they belong to.

- OPVA Programmers are people who are authorized to create their own reports in the Answers component of OBIEE/OPVA, which does not require any programming skills. You can distinguish between people who can simply create ad hoc reports and those who can save the reports they create to a dashboard so that other people can use them.

- INFA Programmers are people who can modify the functionality of OPVA by modifying the predefined ETL Programs that OPVA uses to transform transactional source data in Infa repository for use in OPVA. They may also create new ETL Programs to support custom dashboards and reports in OPVA.

- OPVA Schedulers are people who schedule OPVA jobs, including the data loading job and the user data access jobs. They need privileges similar to INFA Programmers.

- DAC/INFA Administrators are people who set up DAC, including Informatica Setups, and grant privileges to other users.

## 7.2 Setting Up User Authentication

DAC handles creation and maintenance of users for ETL administration of OPVA. OBIEE handles reports related user authentication for OPVA .

### 7.2.1 Creating User Accounts in DAC

You can create user accounts in the following way:

- Create users in DAC. For more information, refer to the Oracle® Business Intelligence Data Warehouse Administration Console Guide.

### 7.2.2 Creating Users and Groups for OPVA

Refer to the Oracle Health Sciences Pharmacovigilance Operational Analytics Installation Guide for instructions on creating users and groups.

### 7.2.3 Implementing Security using OAM and Configuring SSL for OPVA

Refer to the Oracle Health Sciences Pharmacovigilance Operational Analytics Installation Guide for instructions on SSO installation to implement security using OAM, and on configuring SSL for OPVA.