Portal Page Main Tabs

The Home tab consists of the following sections:

My Dashboard

Every user has access to view the dashboard which displays the records that require the logged on users' attention. Users can also configure their own dashboards as needed, or they can use existing dashboards configured by the system administrator.

Management Solutions

All installed Studio solutions are listed under the Home tab. Each section can be expanded to view the options for creating and searching for records in that solution.

Setup and Policy

Users assigned the rights to view or manage admin functions can access the menu options for configuring the setup objects and policies for the applications.

The Smart Solutions tab consists of the following:

My Dashboard

Every user has access to view the dashboard which displays the records that require the logged on users' attention. Users can also configure their own dashboards as needed, or they can use existing dashboards configured by the system administrator.

Smart Solutions

All installed Smart solutions are listed under the Smart Solutions tab. Each section can be expanded to view the options for creating and searching for records in that solution.

Admin and Report

Users assigned the rights to view or manage admin functions can access the menu options for configuring the setup objects, policies, and reports for the Smart applications.

Documents can be logically grouped into folders, called a repository, so that searching and retrieving documents is easier for the end user. Administrators create the repository and define the documents to be located in each folder. The Document Repository tab is used to access all available repositories.

The Administrator Tools tab gives administrators access to:

Administrative Reports

Users assigned the appropriate rights in the system see the following options:

• Audit Trail - This option is used to view the changes that have been made to records.
• View My Queries - This option is used to enter queries for reports. The reports are then listed so that they can be easily accessed and ran.

NOTE: See the Reporting and Analytics Help System for more information about Reports.

Designer

Users assigned the rights to view or manage any types of Studio Designer Tools in the system can access those tools from this location. Those users will see the following options:

• Entity Designer - We provide a library of Technology Solution data models referred to as entities that can be uploaded into the Entity Designer and later opened for modification by the administrator. These entities are not visible until after the upload process has been completed from within Entity Designer.
• Forms Designer - We provide a library of Technology Solution forms (templates) that can be imported into the Forms Designer and later opened for modification by the administrator. These forms are made available on the Customer Support website. Contact your representative for more information on how to obtain these forms.
• Workflow Designer - With complete flexibility over new forms and business rules, functional administrators can easily add any type of process for identifying (collecting), tracking, managing and trending their commitment, incident or event data. Workflow Designer allows users to create new applications and leverage SmartSolve’s ‘Best Practice’ built-in workflow engine, such as Change Management, through the Workflow Designer, to ensure that processes will occur repeatedly with reviews, approvals, time lines, escalations and security. Business rules can be easily applied to form control properties and data objects, along with a library of functions with a visual expression builder for advanced process control.
• SmartInsight - SmartInsight is a user friendly reporting tool that provides business users with the ability to generate specific custom queries and chart the results in a structured grid format.

NOTE: See the Studio Designer Help System for more information on Studio Designer.

Settings

This section is used to configure the settings for the administrator tools. Users assigned the appropriate rights in the system see the following options:

• Application Configuration - The Application Configuration option contains XML configuration files for various SmartSolve capabilities. To modify these files, they should be exported from the database, edited, imported back into the database, and then published to be used by the application.
• Application Options - The Application Options utility gives an administrator permission to activate or deactivate various shared and SmartSolve specific functionality that is or is no longer needed across all organizations. These options can be activated or deactivated at any time by an administrator.
• Application Settings - The Application Settings utility allows the user to create, store, and maintain custom application preferences.
• Deactivation Setup - The Deactivation utility gives an administrator the ability to deactivate Setup objects that are no longer needed by an Organization. For example, a product that your company manufactures has been retired and will no longer need to be made available as an option for end users to select when performing actions in SmartSolve records; therefore, this product (Part Number) needs to be deactivated by an administrator. Deactivated objects become inactive, and are not seen by end users, but remain in the database. Deactivated objects can be reactivated at any time, but not all objects can be deactivated. The list includes objects most likely needing to be deactivated while retaining the (inactive) old record.

• Decision Tree Editor - The Complaint Management application provides a powerful decision making tree. This feature provides pre-populated questionnaires within a strong engine for making rapid decisions on what forms are required for submission. A decision tree can be executed for each supported country's regulatory agency. The decision tree is fully configurable by your system administrator. You can even add a new decision tree and more questions (or change existing questions) if you wish more conclusions to be documented within complaint exceptions (i.e., potentially reportable questions).
• Document Repository Configuration - Documents can be logically grouped into folders, called a repository, so that searching and retrieving documents is easier for the end user. Administrators create the repository and define the documents to be located in each folder using the save search capability. The folder structures can be published for specific actors, roles, departments, organizations or for all organizations. When a user looks for a document they can view the folder structure and are able to search within each folder for the required document. Users can view or check out/in documents directly from the folder list view. A document author is able to create a document directly from the folder in which it will reside. A listing of the documents that reside in a folder can also be exported to Microsoft Excel.
• Organization Hierarchy - The organization hierarchy is the relationship between the various organizational elements. Once the hierarchy is defined, the hierarchy elements such as sites or organization units can be assigned to products and processes for better reporting and metrics. The application provides a default hierarchy that can be configured by the administrator.
• Saved Searches - There are many options in SmartSolve for setting up how end users can search for and look up records as well as perform key analysis on quality and regulatory records. As more SmartSolve records are added to the system and each user accesses different types of records, SmartInsight allows the end user to save previous searches and quickly access them at any time by using the Quick Search function on the Dashboard Portal.
• Submission Forms Configuration - The Complaint Management application provides forms used to collect and submit information recorded in Complaint Management.
• Translation Editor - The Translation Editor provides a mechanism for editing, importing, and exporting customer-specific translation files.
• Workflow Configuration - The Workflow Configuration menu option opens a list of all existing workflows in the SmartSolve system. From this location, the workflow can be imported, exported, and published.

NOTE: See the SmartSolve Utilities and Settings Help System for more information about Settings and Utilities.

Utility

This section is used to access the utility tools. Users assigned the appropriate rights in the system see the following options:

• Application Migration - Application Migration is used to export and import all components related to a Studio Technology Solution such as entities, forms, workflows, saved searches, rights, dashboards, etc. from one environment to another. A designer can now export, then import across different databases, all components that constitutes any business process configured using the Workflow Designer.
• Configure Data Sources - Data Sources for SmartSolve can come from list objects managed within SmartSolve or from an external source managed outside of SmartSolve. The administrator can link Data Sources to field controls when setting up Controls and Properties in the Forms Designer. The ability to use these different data sources within SmartSolve allows businesses to easily adapt applications to their specific business processes, reduce errors, increase repeatability of data capture, enhance application workflow and reduce user error by using business logic.
• Global Ownership Replacement - The Global Replacement utility allows an administrator to easily re-assign pending work from one user to another user. This utility is applicable to tasks assigned on the dashboards as well as some Setup objects included in all SmartSolve applications.
• Manage Reports - SmartSolve comes with default Detail, Pareto, and List reports.
• Regulatory Terms - The Regulatory Terms feature enables the user to import the CDRH Event Codes spreadsheet from the FDA Event Codes webpage. This creates a library of the MedDRA dictionary's lower-level terms. The intent is to pull the PT from the MedDRA Dictionary using the verbatim or symptom term given by the reporter. The MedDRA Dictionary allows the coder to select the LLT – Lower Level Term, Preferred Term (PT) and the SOC (system organ class) and return the code and term into the case for additional reporting.
• Replace Document Type - The Replace Document Type utility provides options for the global replacement of document types. In addition to globally changing document types, the following additional choices are available from within this option: Add, Edit, Delete, Change Administrator Role, and Audit Trail.

License

• User Activities - This option is used to generate a report showing:
• The maximum licenses consumed during a period of time specified by a date range.
• The number of login sessions for a user during a period of time specified by a date range.

NOTE: See the SmartSolve Utilities and Settings Help System for more information about Utilities.

SmartComm™ is the SmartSolve© communication tool used to communicate information to users and systems based on events. Notifications are delivered through an SMTP server. SmartComm plays a key role in processing notifications and application workflow events. The SmartComm tab is used to access:

• Email Notifications
• PDF Reports
• All Queues

NOTE: See the SmartSolve Utilities and Settings Help System for more information about SmartComm.