Administrator Utilities and Settings

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.

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.

The Application Settings utility allows the user to create, store, and maintain custom application preferences.

Audit Trail tracks both new and old values in the database based on changes made by SmartSolve application users and generated by SmartComm. Data is transmitted from the SmartSolve application to the database and recorded in Audit Trail. As daily functions are performed, the Audit Trail tracks your work within the application, and provides the ability to easily retrieve a history of the transactions based on the appropriate rights as per 21 CFR Part 11 Requirements.

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.

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).

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.

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.

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. For additional information, see Saved Searches.

The Complaint Management application provides forms used to collect and submit information recorded in Complaint Management.

The Translation Editor provides a mechanism for editing, importing, and exporting customer-specific translation files.

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.

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.

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.

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.

SmartSolve comes with default Detail, Pareto, and List reports.

The Regulatory Terms feature enables the user to import the CDRH and IMDRF Event Codes spreadsheets from the FDA Event and IMDRF webpages. Regulatory Terms is also where the MedDRA dictionary is maintained once it is imported.

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.

The Delegate functionality gives a user permission to set up out of office options for users of new workflows in SmartSolve. For example, a workflow approver will be out of the office for a week, and needs to be assigned an alternate for that week while they are out of the office.

The Deployment Migration Utility (DMU) is used to facilitate the migration of SmartSolve setup, policies and models from a SmartSolve test/QA environment to the SmartSolve production environment.

The Skipped Number Log is used by the administrator to access the log of skipped records, and reassign, if necessary, records that have previously been deleted.

SmartComm is the SmartSolve communication tool used to communicate event information to users and systems. Notifications are delivered through an SMTP server. SmartComm plays a key role in processing notifications and application workflow events. For additional information see, Application Default Notifications.