The SmartSolve© List Manager allows you to create standardized lists of information codes as master setup values. This significantly reduces data capture errors, reduces data duplication and increases data accuracy by providing end-users a consistency in data entry leading to meaningful reporting of information. The SmartSolve© List Manager tool supports custom list tables for both simple and complex lookups, and all lists can be defined at either your company’s global or local level.
The following rights must be assigned to a user to manage or view Lists:
Rights |
Description |
LST_MANAGE |
Allows administrator to add new object, modify existing object, or delete object.
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See Rights Group to assign Rights Groups to users.
Default Data List |
Application Used |
Description |
SmartComplaintsTM
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Default Acknowledgement Reason Codes for eMDR using B2B include: FDA Gateway Down Internal Transmission Failure These Codes are entered automatically by the system when using B2B with Complaints Synchronization Agent. Additional Reason Codes can be entered if end users need to enter Acknowledgement Codes manually.
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SmartCAPATM SmartComplaintsTM SmartAuditTM
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Action Plan Types can be used within Exception and Issue Tasks which help to categorize types of Actions that may be carried out by action plan assignees. Default Action Plan Types include: Corrective Preventive Additional Action Plan Types can be added by an administrator.
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SmartComplaintsTM
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Activity Types can be entered in the Complaint Exception throughout its life cycle by the Exception Owner. Default Activity Types include: Remark Sample Forward Customer Contact Regulatory Agency Contact Additional Activity Types can be added by an administrator.
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SmartComplaintsTM |
A Contact Type is required when entering Client Information in the Complaint Exception. Default Contact Types include: CUSTOMER END USER SALES REP SUPPLIER Additional Contact Types can be added by an administrator.
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SmartComplaintsTM
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The Country of Origin is entered in the Complaint Exception and represents the country where the event occurred, this field can be used later in analysis of what country regulatory reports may be affected. One default Country of Origin is included: United States. Additional values can be added by an administrator.
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SmartCAPATM SmartComplaintsTM SmartAuditTM
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The Reference tab within the Exception record helps the Exception Owner to identify any related references to an Exception. Any of the references that are external to the SmartSolve© system can be categories using this External Reference Type. One default External Reference Type is included: External Reference. Additional values can be added by an administrator.
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All |
If needed, Org Unit Types can be applied to any Departments created in your system for better grouping. Default Org Unit Types include: CONTRACTOR CUSTOMER REGULATORY AGENCY SUPPLIER AUTHORIZED REPRESENTATIVE COMPETENT AUTHORITY NOTIFIED BODY MANUFACTURER
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SmartCAPATM SmartComplaintsTM
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The Product Type is entered in the Exception and differentiates the type of product defined in the event; for example, combination device or Medical Device. Customers can drill down and create another level if they need to differentiate their products,this field can be used in your Regulatory Reporting Policy as a differentiator for what plant registration number to use for your MedWatch reporting. Default Product Types include: Combination Product Medical Device Additional Product Types can be added by an administrator.
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SmartComplaintsTM
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The Requested Action is entered in the Complaint Exception and identifies what the action was, requested by the Customer. Default Requested Actions include: Credit None Repair Replacement Additional Requested Actions can be added by an administrator.
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SmartComplaintsTM
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The Sample Location is entered in the Complaint Exception and identifies where the defective sample is located. Default Sample Locations include: Customer Distributor Manufacturer Sales Representative Additional Sample Locations can be added by an administrator.
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SmartCAPATM
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Activity Types can be entered in any SmartCAPATM Exception throughout its life cycle by the Exception Owner. Default Activity Types include: Containment Justification Immediate Actions Results of Investigation Additional Activity Types can be added by an administrator.
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SmartComplaintsTM
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The Submission Reporting Site is triggered from the Regulatory Reporting Policy and it specifies “who is performing your Adverse Event Report” to the regulatory body. Default Reporting Sites include: Manufacturing Site Reporting Site Importer/Distributor There is no need to add additional Submission Reporting Sites. The three defaults are available based on system logic and work with the Policy.
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From the SmartSolve© Admin tab select Setup > System Wide > Lists.
It is important to first understand the components used within the work area of the List Manager. The following definitions will help you to become familiar with some of these components. More information on these components is included in their own Topics throughout Working with List Manager.
Work Area Components |
Definition |
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Add New List Object |
Select the Add New List Object option to add new data lists to SmartSolve©.
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Add/Modify Existing List Objects |
Select the Add/Modify Existing List Objects option to modify existing data lists in SmartSolve©. You must be logged into the global organization to do this.
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Parent List Objects |
Relationships can be created between lists. For example, when a division is selected from a drop down field in an exception record, the Manufacturing Site field might only display the manufacturing sites listed within the division selected. In this case, the Division List would be the parent object to the Manufacturing Site List Object.
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New Lists can be added to the List Manager if standard data needs to be applied to new or existing SmartSolve© fields. New Lists can later be linked to the field through the Forms Configurator, or Forms Designer.
1. From the Portal Page, click Smart Solutions tab > Admin and Report > Setup. Under System Wide, select Lists.
The List Manager workspace displays.
2. Select Add New List Object from the workspace.
3. Enter the New List Object Name.
4. Select the Parent List Object (if applicable).
Parent List Object
Relationships can be created between Lists. For example, when a Division is selected from a drop down field in an Exception record, the Manufacturing Site field might only display the Manufacturing Sites listed within the Division selected. In this case, the Division List would be the Parent Object to the Manufacturing Site List Object.
5. Click the Next button.
The new List has been added and the List Value workspace displays.
1. From the List Value Workspace click the Add button.
2. Enter the new List Value.
3. Select the Parent List Value (if applicable).
4. Enter the Sort Order (how will the data be displayed).
5. Click the Save button once all List Values have been entered.
Saved Successfully is now displayed over the Save button.
Data List Names cannot be edited once created in the system, only Data List Values can be edited. You must delete and start over if you wish to rename so be careful!
1. From the Portal Page, click Smart Solutions tab > Admin and Report > Setup. Under System Wide, select Lists.
The object list displays.
2. Select Add/Modify Existing List Object Values.
3. Select the List Object Name from the drop down menu.
4. Click the Next button.
5. Modify the appropriate List Values, Parent List Values, and/or Sort Order.
6. Click the Save button.
All changes are now reflected in the list.
Data Lists can only be deleted from SmartSolve© if the List has not currently been attached to any SmartSolve© records.
1. From the Portal Page, click Smart Solutions tab > Admin and Report > Setup. Under System Wide, select Lists.
The object list displays.
2. Select Add/Modify Existing List Object Values.
3. Select the List Object Name from the drop down menu.
4. Click the Next button.
5. Check off all Data Values to be deleted.
NOTE: If all Data Values are removed, the entire List will be removed. |
6. Click the Save button.
The object has now been removed from the system.