The Grand Avenue Software module for Complaint Handling and Incident Reporting is based around a seven-step process:
%%{init: {"flowchart": { 'padding':'5', 'curve': 'basis', "htmlLabels": false }} }%%
flowchart LR
Submit["`**Submit New Request**`"];
Review["`**Review New Issue**`"];
Initiate["`**Initiate Complaint**`"]
Investigate["`**Investigate and Resolve**`"];
Closed["`**Close Complaint**`"]
Reporting["`**Initial Reporting**`"]
FollowUp["`**Follow-up Reporting**`"]
Initiate --> Reporting --> FollowUp --> Closed;
Submit --> Review --> Initiate --> Investigate ---> Closed;
click Submit "#ComplaintSubmitNewIssue" "Submit New Issue"
click Review "#ComplaintReviewNewIssue" "Review New Issue"
click Initiate "#ComplaintInitiateComplaint" "Initiate Complaint"
click Investigate "#ComplaintInvestigate" "Investigate and Resolve"
click Reporting "#ComplaintInitialRegulatoryReporting" "Initial Regulatory Reporting"
click FollowUp "#ComplaintFollowupReportingForZone" "Follow-up Regulatory Reporting"
click Closed "#ComplaintCloseComplaint" "Review and Closure of the Complaint"
As external issues are reported to a company, they are entered into the Grand Avenue Complaint Handling system. This allows the company to easily track all external issues in a single, consistent manner, and ensure that they are all reviewed to determine which ones should be treated as complaints. Issues for which a complaint has been initiated will remain open for changes until the complaint is closed.
For issues that don't qualify as Complaints, the process also allows an organization to address the issue with an integrated hand-off to the CAPA process.
To begin the process of submitting a new issue, click the "Submit New Issue" link on the navigation menu. The software will automatically take you to the Add Issue page, where you will be assisted in providing as much detail as possible about the event that occurred. After filling out all necessary fields, you will submit the issue into the Complaint Handling process, where it will be reviewed by a Complaint Module Coordinator to determine whether or not the issue should be treated as a Complaint (see the Review New Issue task).
If the Complaint Module Coordinator needs additional information about the issue prior to approving it as a Complaint, they may decide to return the issue to you as the Initiator. A Submit New Issue task will appear in your "My Tasks" page, along with an email notification of the task. You will see the feedback entered by the Complaint Module Coordinator and will be responsible for addressing those concerns before resubmitting the issue.
The Add/Edit Issue page is split into sections:
Once you have finished entering all of the background information about this issue, you can submit it for review by clicking the "Save and Proceed to Signoff" button. You'll be taken to a subsequent page where you can enter any additional comments and your signoff key to complete the signoff (see Sign Off Submit New Issue).
To save your work and return to it later, click the "Save for Later" button. You will receive an assignment to complete this task in your "My Tasks" page.
If you decide that the issue is no longer valid, click the "Delete" button to remove it from the system. This button will only appear if the issue has been saved and you have an open task assignment.
Clicking the "Cancel" button will discard any information you have entered and return you to the "My Tasks" page.
Once you have finished updating any necessary information about this Issue, click the "Save Changes" button to commit your changes and return to the previous page.
Clicking the "Cancel" button will discard any information you have entered and return you to the previous page.
To upload a file containing background information about an issue, enter a brief description of the file and then click the "Browse" or "Choose File" button to find and select the file from your local machine. Once you have selected the file, click the "Save" button to upload the file and return to the Edit Issue page.
If you have chosen to make change to a previously uploaded file, the page will display a link to the current version. You can replace the current version by selecting another file.
Click the "Cancel" button to discard any changes and return to the Edit Issue page.
Use the "Comments" field to record any additional comments with your signature. Then enter your signoff key and click the "Sign Off" button. Your task will be closed, and a Review New Issue task will be assigned to the Complaint Module Coordinator(s).
Click the "Cancel" button to return to the previous page without signing off on the task.
When a new issue is submitted to the process, a Review New Issue task assignment is created authorizing a Complaint Module Coordinator to determine how the issue should be handled. The primary responsibility for this task is to review all of the information provided by the issue Initiator and decide whether or not the issue should be handled as a complaint and submitted into the Complaint Handling process. If the issue does not constitute a complaint, the user can instead decide to submit it into the CAPA process for additional review as a potential opportunity for action. If an issue does not need to be processed as a complaint or a CAPA, the Complaint Module Coordinator can close the issue with an explanation about the need for no further action.
The Review New Issue page provides you with an overview of the submitted issue.
Verify that all necessary information has been completed and is accurate, using the "Edit Issue" button to make any required updates (see Edit Issue).
When you have determined the appropriate process for resolving the issue, use one the following buttons to move it to the next step:
If you are not ready to make a decision about the disposition of this issue, you can click the "Finish Later" button to return to the "My Tasks" page.
This action will automatically create a Complaint from the Issue and initiate the Complaint Handling process.
To proceed with this action, enter any necessary information into the Comments field and sign off on the decision by entering your signoff key and clicking the "Submit Issue As Complaint" button. The Status of the issue will be changed to "Pending", where it will remain until the Complaint is closed. You will be taken directly to the Initiate Complaint page to begin the Complaint Handling process.
If you are not ready to make a decision about the disposition of this request, you can click the "Cancel" button to discard your comments 0and return to the Review New Issue page.
If the Issue does not need to be handled as a Complaint, but still requires additional investigation and potential action, you can use this action to automatically create a CAPA request and initiate the CAPA process.
To proceed with this action, use the Comments field to record a justification for why the Issue does not need to be processed as a Complaint. Then enter your signoff key and click the "Submit Issue As CAPA" button. The Status of the issue will be changed to "Closed", the "Issue Closed Date" will be recorded and you will be taken to a CAPA task page to initiate a new CAPA to address the issue (see Integration with CAPA Process).
If you are not ready to make a decision about the disposition of this request, you can click the "Cancel" button to discard your comments and return to the Review New Issue page.
If you require additional information to determine the appropriate disposition of this Issue, you can use this action to send the Issue back to a designated assignee to provide that information.
To proceed with this action, select an assignee and due date for the task, and then use the Task Instructions field to provide guidance to the assignee on what additional work/information is required.
If you are not ready to make a decision about the disposition of this request, you can click the "Cancel" button to discard your comments and return to the Review New Issue page.
If you determine that the Issue has been fully addressed and does not need require additional processing as a Complaint or a CAPA, you can use this selection to officially close the Issue.
To proceed with this action, use the Comments field to record a justification for why the Issue can be closed without being processed as a Complaint or CAPA Request. Enter your signoff key and click the "Close Issue With No Further Action" button. The Status of the issue will be changed to "Closed" and the "Issue Closed Date" will be recorded.
If you are not ready to make a decision about the disposition of this request, you can click the "Cancel" button to discard your comments and return to the Review New Issue page.
The Complaint Handling process is initiated whenever a Complaint Module Coordinator determines that an issue should be treated as a complaint. The process begins with the Initiate Complaint task, where a Complaint Module Coordinator is assigned to prioritize the complaint, determine if the Regulatory Reporting Process is potentially required, determine whether to notify the Field Action team for review, and determine if an investigation should be performed.
If the Complaint Module Coordinator determines that there is a potential need for regulatory reporting, the Initial Regulatory Reporting task will be assigned to a Regulatory Reporter. That user will be responsible for determining if the event is reportable in each configured reporting zone, and preparing any necessary reporting forms for submission (see Regulatory Reporting Process).
If the Complaint Module Coordinator determines that an investigation is necessary, the Investigate task will be assigned to a lead Investigator, who will be responsible for managing the team of analysts and working with them to record the results of their investigation activities.
If the Complaint Module Coordinator determines that a CAPA process is necessary, a CAPA process can be initiated.
When all necessary decisions have been made, the Complaint Module Coordinator can sign off the Initiate Complaint task. When all initiated processes have completed, the complaint will proceed to the Review for Closure task.
The Initiate Complaint task authorizes a Complaint Module Coordinator to determine how a complaint will be processed. In this task, the Complaint Module Coordinator is responsible for:
This page allows the assignee of the Initiate Complaint task to initiate any necessary processes for a complaint.
Determine the priority of the complaint. The "Decision Records for Complaint Priority" table shows a history of any decisions about changes to the Priority.
Click the "Edit Priority" button to set the priority of the complaint (see Edit Priority).
Review each potential impact in the Process Impacts table and specify whether it is applicable for the Complaint. Click the corresponding "Edit" button for a process impact to record your decision (see Edit Process Impact). If you determine that an impact is not applicable, you may be required to record a justification of why it does not apply.
Process Impacts identified as applicable for the Complaint may require the assignment of Impact Implementation tasks. Click the "Assign Impact Implementation Tasks" button to assign tasks (see Select Process Impacts to Assign).
If no Process Impacts have been configured by Complaint Module Administrators, this section will not be displayed (see Configure Complaint Process Impacts).
Determine whether an investigation process is required for this complaint. The "Decision Records for Initiate Investigation Process" table shows a history of any decisions that have already been made about an investigation.
The "Investigation Tasks" table shows any open or completed Investigate tasks that have been assigned.
Click the "Initiate Investigation Process" button to select an assignee and due date for the Investigate task (see Initiate Investigation Process).
Click the "Record Justification for No Investigation Process" button to document why an investigation is not needed (see Record Justification for No Investigation Process).
Determine whether the CAPA process should be initiated for this complaint. The "Decision Records for Initiate CAPA Process" table shows a history of any decisions that have already been made about the CAPA process for this complaint.
If the CAPA module is in use, initiating the CAPA process will start a CAPA Request for this complaint.
If the CAPA module is not use, initiating the CAPA process will create an Initiate External CAPA task.
Click the "Initiate CAPA Process" button to start the CAPA process (see Initiate CAPA Process).
Click the "Record Justification for No CAPA Process" button to document why a CAPA process is not needed (see Record Justification for No CAPA Process).
Determine whether the regulatory reporting process should be initiated for this complaint (see Regulatory Reporting Process). The "Decision Records for Initiate Regulatory Reporting Process" table shows a history of any decisions that have already been made about initiating the regulatory reporting process.
The "Regulatory Reporting by Zone" table shows a summary of the results of reporting decisions for each configured Regulatory Reporting Zone.
The "Regulatory Reporting Tasks" table shows any open or completed regulatory reporting tasks that have been assigned for this complaint.
Click the "Initiate Regulatory Reporting Process" button to select an assignee and due date for the Initial Regulatory Reporting task (see Initiate Regulatory Reporting Process).
Click the "Record Justification for No Regulatory Reporting Process" button to document why the process is not needed (see Record Justification for No Regulatory Reporting Process).
Determine whether the Field Action team in your organization should be notified about this complaint (see Notify Field Action Team). The "Notify Field Action Team Tasks" table shows any open or completed tasks that have been assigned for this complaint.
Click the "Initiate Field Action Process" button to select an assignee and due date for the Notify Field Action Team task (see Initiate Field Action Process).
If your organization has configured custom fields for complaints you are responsible for selecting values for each field. Click the "Edit Complaint Information" button to make changes to the field values (see Edit Complaint Custom Field Values).
Click the "Edit Issue Information" button to make any necessary updates to the information on the Source Issue for this complaint (see Edit Issue).
Once all required processes have been initiated (or a justification provided for why each isn't necessary), you can click the "Proceed to Signoff" button to sign off the task (see Sign Off Initiate Complaint).
Click the "Finish Later" button to return to the "My Tasks" page.
Indicate the priority of the complaint and provide a justification for the decision.
To upload a file containing supporting information about your decision, click the "Browse" or "Choose File" button to find and select the file from your local machine.
Click the "Save" button to save your changes and return to the previous page. A decision record will be added to the complaint to log your decision and justification.
Click the "Cancel" button to return to the previous page without saving your changes.
Select a user that will be assigned to perform the investigation.
A decision record will be added to the complaint to log your decision and justification.
Click the "Initiate Investigation Process" button to assign the task and return to the previous page.
Click the "Cancel" button to return to the previous page without initiating the process.
Use the "Justification" field to document why an investigation is not needed. A decision record will be added to the complaint to log your decision and justification.
To upload a file containing supporting information about your decision, click the "Browse" or "Choose File" button to find and select the file from your local machine.
Click the "Record Justification" button to save your changes and return to the previous page.
Click the "Cancel" button to return to the previous page without saving your changes.
Select a user that will be assigned to initiate the CAPA process.
A decision record will be added to the complaint to log your decision and justification.
Click the "Initiate CAPA Process" button to assign the task and return to the previous page.
Click the "Cancel" button to return to the previous page without initiating the process.
Use the "Justification" field to document why the CAPA process is not required for this complaint. A decision record will be added to the complaint to log your decision and justification.
To upload a file containing supporting information about your decision, click the "Browse" or "Choose File" button to find and select the file from your local machine.
Click the "Record Justification" button to save your changes and return to the previous page.
Click the "Cancel" button to return to the previous page without saving your changes.
Select a user that will be assigned to perform the Initial Regulatory Reporting task. The user will be responsible for examining the complaint to determine if it needs to be reported to the regulatory agencies for each zone and then filling out any necessary forms. The regulatory reporter should be a person with the training and experience to correctly fill out the reporting forms for regulatory agencies in all the countries that the product is sold into.
A decision record will be added to the complaint to log your decision and justification.
Click the "Initiate Regulatory Reporting Process" button to assign the task and return to the previous page.
Click the "Cancel" button to return to the previous page without initiating the process.
Use the "Justification" field to document why the Regulatory Reporting process is not required for this complaint. A decision record will be added to the complaint to log your decision and justification. If reporting was not previously completed for this complaint, the system will automatically mark each zone as not reportable.
To upload a file containing supporting information about your decision, click the "Browse" or "Choose File" button to find and select the file from your local machine.
Click the "Record Justification" button to save your changes and return to the previous page.
Click the "Cancel" button to return to the previous page without saving your changes.
Select a user that will be assigned to perform the Notify Field Action Team task. The user will be responsible for notifying your organization's Field Action team that this Complaint has a potential need for field action, and that they should review it to determine whether action is actually required.
Click the "Initiate Field Action Process" button to assign the task and return to the previous page.
Click the "Cancel" button to return to the previous page without initiating the process.
The custom field values for a Complaint can be set at three different points in the Complaint process: Initiate Complaint, Investigate, and Review for Closure. At each opportunity, you should attempt to provide accurate values for all custom fields. During Initiate Complaint and Investigate, if you do not know the correct value for custom fields that are configured to be "Conditionally Required" you can leave them blank. However, once the complaint has reached the Review for Closure step, you must enter a value for those fields.
The values that are appropriate for each custom field are configured by Complaint Module Administrators according to your company's process. Specific assistance for each custom field is available by clicking the "What value should I enter?" link next to the field.
Click the "Save" button to save the values you have selected and return to the previous page.
Click the "Cancel" button to discard unsaved changes and return to the previous page.
Record any additional comments, then enter your signoff key and click the "Sign Off" button to sign off on this task. When all processes have been completed the system will automatically initiate the Review for Closure task.
Click the "Cancel" button to discard unsaved changes and return to the previous page.
When the organization determines that there are potential field action requirements for a complaint, a Notify Field Action Team task assignment can be initiated. The user that receives this assignment is responsible for notifying the organization's Field Action team about the complaint, using the organization's established process. The task is completed when the user records that the Field Action team has been notified.
The Field Action process is optional and must be enabled by Complaint Module Administrators (see Configure Complaint Process Options).
The Notify Field Action Team page displays a summary view of the Complaint, to assist you in providing any necessary detail to the Field Action team. Once you have notified the Field Action team about the Complaint, you can sign off the task as complete by including any additional information into the Comments field, entering your signoff key and clicking the "Signoff" button.
When the Complaint Module Coordinator determines that an investigation is required for a particular complaint, they assign a lead Investigator for the complaint. The investigator is responsible for initiating research activities to gather the necessary background information for the investigation, documenting the results of activities in the complaint's activity log (see the Add Activity Log Entry page), and documenting the resolution of the complaint when the investigation has been completed (see the Finish Investigation page).
During the investigation, the Investigator may also delegate research tasks to other individuals (see the Assign Research Task page), which in turn allows them to document the results of their research activities into the complaint's activity log. Prior to finishing the Investigation, the investigator also has the opportunity to enter values for any custom fields.
At any point during the investigation the investigator can also initiate a CAPA Request to further research any problems that are identified.
If the Field Action process has been enabled (see Configure Complaint Process Options), the investigator can initiate the process by assigning a user a task to notify the organization that this complaint has a potential need for field action and that they should review it to determine whether action is actually required.
Once the Investigate task has been completed, a Complaint Module Coordinator will be assigned the task of reviewing the complaint for closure (see the Review for Closure task).
The Investigate page is the main navigation point for the Investigator. In addition to providing a summary view of the complaint background, it also displays the entries that have been made into the complaint's activity log and a list of all research tasks that have been assigned.
When you need to assign someone a research activity, click the "Assign Research Task" button (see the Assign Research Task page).
When you need to record the results of an activity, click the "Add Activity Log Entry" button (see the Add Activity Log Entry page). You may also edit any of the existing log entries by clicking the "Edit" button next to the entry in the grid (see the Edit Activity Log Entry page).
Determine whether the CAPA process should be initiated for this complaint. The "Decision Records for Initiate CAPA Process" table shows a history of any decisions that have already been made about the CAPA process for this complaint.
If the CAPA module is in use, initiating the CAPA process will start a CAPA Request for this complaint.
If the CAPA module is not use, initiating the CAPA process will create an Initiate External CAPA task.
Click the "Initiate CAPA Process" button to start the CAPA process (see Initiate CAPA Process).
Click the "Record Justification for No CAPA Process" button to document why a CAPA process is not needed (see Record Justification for No CAPA Process).
Determine whether the Field Action team in your organization should be notified about this complaint (see Notify Field Action Team). The "Notify Field Action Team Tasks" table shows any open or completed tasks that have been assigned for this complaint.
Click the "Initiate Field Action Process" button to select an assignee and due date for the Notify Field Action Team task (see Initiate Field Action Process).
If your organization has configured custom fields for Complaints you are responsible for filling them out using available information. Click the "Edit Complaint Information" button to take you to the Edit Complaint Custom Field Values page. NOTE: This button will only appear if custom fields have been defined by Complaint Module Administrators.
Click the "Edit Issue Information" button to make any necessary updates to the information on the Source Issue for this complaint (see Edit Issue).
At any point during the Investigation you can click the "Finish Later" button to return to the "My Tasks" page.
Once all necessary investigation activities have been completed and documented, you can close the investigation by clicking the "Finish Investigation" button (see the Finish Investigation page).
The Assign Research Task page is used by the Investigator to delegate investigation activities to other individuals during the investigation of a complaint.
After providing a description of the research task that needs to be performed, specify who will be given the assignment and the date by when it should be completed, then click the "Assign Task" button.
Click the "Cancel" button to return to the previous page without assigning the task.
The Finish Investigation page allows you to record the resolution for the complaint and close the Investigation.
Before entering the resolution, review the information about the complaint and the investigation's activity log shown on the page. If all of the investigation activities are complete and the information is correct, proceed with recording the final resolution for this Complaint in the Resolution field.
Record any additional comments, then enter your signoff key and click the "Sign Off" button to sign off on this task. When all processes have been completed the system will automatically initiate the Review for Closure task.
Click the "Cancel" button to discard unsaved changes and return to the previous page.
During the investigation of a complaint, the Investigator may need to delegate research tasks to individuals. A "Research Complaint" assignment is created for each delegated task, allowing the assigned individual to record their activities into the complaint's activity log until they've completed the assignment.
The Research Complaint page provides you with an overview of the complaint and a set of instructions from the lead Investigator on what work needs to be performed.
At any time while you have this assignment, you may record activities into the complaint's activity log by clicking the "Add Activity Log Entry" button (see the Add Activity Log Entry page).
You can also edit any activity you have created by clicking the "Edit" button next to the activity (see the Edit Activity Log Entry page).
When you have completed and documented all of the required work, you can close the assignment by clicking the "Proceed to Signoff" button, which will take you to the Sign Off Research Task page.
To close a completed Research Task assignment, enter your signoff key and click the "Sign Off" button. The Investigator will receive an email notification that you have completed the task.
You can also return to the Research Complaint page without signing off the task by clicking the "Cancel" button.
Once all tasks have been completed for a complaint, a Complaint Module Coordinator is responsible for reviewing and updating any information about the complaint prior to officially closing the complaint.
The Review for Closure task is assigned as follows:
The Complaint Module Coordinator can also return the complaint to the Initiate Complaint task to initiate any required follow-up processes (investigation, regulatory reporting, etc.).
The Review for Closure page allows you to review the entire history of a complaint and make any necessary changes prior to closing the complaint.
Before closing the complaint, you can review and edit the history of activities recorded in the Activity Log.
Verify that the Resolution is complete and accurate.
If your organization has configured custom fields for complaints, you are also responsible for filling them out using available information. All fields must be completed before you can close the complaint. Click the "Edit Complaint Information" button to take you to the Edit Complaint Custom Field Values page.
If any of the information about the Source Issue for this complaint is incomplete or inaccurate, click the "Edit Issue Information" button to make any necessary updates (see Edit Issue).
You can click the "Save for Later" button to save changes to the Resolution and return to the "My Tasks" page without closing the complaint.
To close the complaint, click the "Save and Proceed to Signoff" button to proceed to the next page:
Click the "Return to Initiate Complaint" button to return the complaint to the Initiate Complaint task to initiate any required follow-up processes (see Return to Initiate Complaint).
Click the "Cancel" button to discard any unsaved changes and return to the "My Tasks" page.
Use the "Instructions for performing the task" field to indicate what additional work needs to be completed.
Identify the user that will be assigned the task and the date by which it should be completed.
Enter your signoff key and click the "Return to Initiate Complaint" button. Your task will be closed and the complaint will be returned to the Initiate Complaint task, where the assignee will be able to initiate any necessary processes (e.g. CAPA, Investigation, etc.).
Click the "Cancel" button to discard any unsaved changes and return to the previous page.
To close the complaint, enter your signoff key along with any final comments about the complaint and then click the "Sign Off" button.
When the Complaint Module Coordinator closes the complaint, a notification will be sent to the initiator of the original issue, and the Status of both the Complaint and its Source Issue will be changed to "Closed".
To postpone closing the complaint until later, click the "Cancel" button and you will be returned to the previous page.
This page displays the list of Complaint Review Boards that have been configured for your organization (see Configure Complaint Review Boards).
Click the "Select" button for the appropriate review board for approving the closure of the Complaint. You will be taken to the Initiate Approve Closure page to assign users for each of the review board roles.
Click the "Cancel" button to return to previous page without selecting a review board.
Select users to assign for each of the approver responsibilities. The default list of responsibility areas for the selected review board is defined by Complaint Module Administrators (see Configure Complaint Review Boards). Task instructions will indicate the minimum number of responsibility areas required for Approve Closure and the minimum number of unique people that must be assigned.
Select a date by which the users must complete their assignments, then enter any additional comments and your signoff key, and click the "Initiate Approve Closure" button. Your Review Closure task will be closed, and the users you selected will receive Approve Closure tasks.
Clicking the "Cancel" button will return you to the previous page without initiating the Approve Closure process.
Users assigned an Approve Closure task are required to review the Complaint to determine if it is ready to be closed.
If all assignees approve the closure, a notification will be sent to the initiator of the original issue, and the Status of both the Complaint and its Source Issue will be changed to "Closed".
If any of the assignees rejects the closure, the Complaint will be sent back to the Review for Closure task once everyone has signed off.
Complaint Module Coordinators can cancel open Approve Closure tasks using the Manage Approve Closure page.
The Approve Closure page provides an interface for reviewing the Complaint. The page also displays the status and comments of other approvers in the "Approvers" table.
Once you have finished reviewing the information provided, you can indicate your approval or rejection of the closure in the "Approve Closure?" field.
Once you have recorded your decision and any necessary feedback, complete the task by entering your signoff key and selecting the "Sign Off" button.
Click the "Cancel" button to discard any changes and return to the "My Tasks" page.
The Regulatory Reporting Process for Complaints is initiated when a Complaint Module Coordinator determines that a Complaint should be evaluated for potential regulatory reporting. The process begins when the Complaint Module Coordinator assigns a Regulatory Reporter to prepare any necessary reports of the Complaint as required by various regulatory agencies within the amount of time allowed by the regulatory agency for each reporting zone (see the Initial Regulatory Reporting task). The Regulatory Reporting Reviewer for each zone reviews and corrects the reports as they become ready, sends them to the appropriate regulatory agencies, and records the date that they were sent (see the Review Initial Regulatory Reporting task). For reporting zones that have been configured to require follow-up for reportable events (e.g. European Union), a task to generate follow-up reports at a later date is assigned to the Regulatory Reporter (see Follow-up Regulatory Reporting). When those reports are prepared, the Regulatory Reporting Reviewer for the zone again reviews, corrects, and sends those follow-up reports to the appropriate regulatory agencies (see Review Follow-up Regulatory Reporting).
The list of reporting zones that must be evaluated during the Regulatory Reporting process is configured by Complaint Module Administrators using the Configure Regulatory Reporting Zones page.
The Initial Regulatory Reporting task is assigned to a Regulatory Reporter by the Complaint Module Coordinator during the Initiate Complaint task. This task is performed in parallel with any necessary investigation and field action, due to the time-sensitive nature of regulatory reporting requirements. The reporter is responsible for determining which countries or "reporting zones" a product is sold into and, for each of those zones, whether the complaint constitutes a reportable event. For each zone that requires regulatory reporting, the reporter determines the date by which all initial reporting forms must be submitted, and then fills out and uploads copies of the forms. Once all forms have been completed, the reporter can sign off the task, and the Complaint Module Coordinator will be given the Review Initial Regulatory Reporting task to review the decisions and forms, and submit them to the appropriate regulatory agencies.
The Initial Regulatory Reporting page provides a summary of all reporting zones that must be considered when evaluating regulatory reporting requirements. For each reporting zone, the summary table displays the decisions that you have made, along with a status indicator for whether the necessary forms have been completed and submitted to the appropriate regulatory agencies. The table also displays whether or not a zone will require follow-up reporting if you determine that the complaint is reportable for that zone. As you complete and sign off each reporting zone, the table will be updated to reflect your decisions and the current status of the zone.
For each reporting zone, you will need to record whether the complaint constitutes a reportable event in that zone. To record information for a particular reporting zone, click on the "Update" button for that entry in the table. You will be taken to the Initial Reporting For Zone page, where you will be able to record the decisions for that zone and upload any necessary reporting forms as they are completed.
Once you have recorded decisions for each zone and completed any necessary forms, you can close the assignment by clicking the "Proceed to Sign Off" button. This will take you to the Sign Off Initial Regulatory Reporting page.
The Initial Reporting for Zone page provides a way to record all of the information for a given zone about the initial regulatory reports. For each zone, there are up to three possible steps that will need to be completed:
You can click the "Save and Finish Later" button to save your changes to the Reportable Event and Initial Reporting Due Date fields.
Clicking the "Cancel" button will discard any pending changes to those fields and return you to the previous page.
Clicking the "Save and Proceed to Signoff" button will save any changes on this page and take you to the appropriate signoff page for your task (the Sign Off Initial Reporting for Zone page if you are a Regulatory Reporter creating reports, or the Sign Off Initial Submission for Zone page if you are a Regulatory Reporting Reviewer reviewing and submitting reports to a regulatory agency).
The Add/Edit Reporting Form page allows you to upload an electronic copy of forms completed as part of the regulatory reporting process. For example, in the United States reporting zone, you can upload the completed copy of the MedWatch 3500A form. As another example, if your organization uses a decision form to determine/record whether reporting is required for a zone, you can upload a completed copy of that form.
When uploading a reporting form for the first time, you must enter a description of the form and click the "Browse" or "Choose File" button to find and select the file from your local machine. Once you have entered the description and selected the appropriate file, click the "Save" button to save the electronic copy into the system.
When editing a previously uploaded form, you can change the description and/or upload a new file. Clicking the "Save" button will record your changes in the system.
Clicking the "Cancel" button will discard any changes and return you to the previous page.
The Sign Off Initial Reporting for Zone page allows you to sign off the zone when it has been completed. If you determined that the event is reportable, the reporting forms should be made available to the Complaint Module Coordinator for review. The Regulatory Reporting Reviewer for the zone will then review the reporting decision and any uploaded forms during the Review Initial Regulatory Reporting task.
Once you sign off on the reporting information for this zone, you will no longer be able to change the reporting information for this zone. Other zones which have not been signed off will remain editable.
To sign off on the zone, enter your signoff key and click the "Sign Off" button. You will be taken back to the Initial Regulatory Reporting page to continue working on any remaining reporting zones. If all zones have been signed off, you will be taken to the Sign Off Initial Regulatory Reporting page to sign off on the task.
To return to the Initial Reporting For Zone page without signing off on the zone, click the "Cancel" button.
Once all of the zones have been completed and signed off you can sign off the Initial Regulatory Reporting task.
Enter your signoff key along with any additional comments and click the "Sign Off" button.
Clicking the "Cancel" button will return you to the Initial Reporting for Zone page without signing off on the task.
The Review Initial Regulatory Reporting task is assigned when a Regulatory Reporter has finished preparing a Complaint's report for the regulatory agency in one reporting zone. The task is either assigned to the Regulatory Reporting Reviewer configured for the zone (see Configure Regulatory Reporting Zones), or assigned to the Complaint Module Coordinator if no reviewer has been configured.
The user's task is to review the reports prepared by the Regulatory Reporter (including any uploaded files), make any changes that are necessary, send the reports to the appropriate regulatory agency for the reporting zone that's involved, and record the date that the reports were sent. NOTE: Any reporting forms that have been uploaded are termed "Initial", but if a zone has not been configured to require follow-up reporting, these will be the only reports recorded for that zone.
The Initial Reporting for Zone page is used for performing this task.
On this page you are verifying that you have reviewed, corrected, and sent all necessary initial reporting forms for a Complaint to the regulatory agency for the specified reporting zone.
The page displays information about the Complaint and the reports made to the regulatory agency for a particular zone.
If reporting was required for this zone, fill in the actual date that the forms were sent to the regulatory agency for the specified zone, along with any comments you wish recorded about your task of reviewing, correcting, and sending the reports. If the zone has been configured to also require follow-up reporting for reportable events, you must specify the date by which the assigned Regulatory Reporter should complete those forms.
When you enter your signoff key and click the Signoff button, your changes are recorded, and the Initial Reporting for Zone task is complete and removed from your task list.
If you click the Cancel button, your changes are ignored, you are returned to the Initial Reporting for Zone page so you can review or make more changes, and the Review Initial Regulatory Reporting task remains in your task list so you can complete it at a later time.
The Follow-up Regulatory Reporting task is created for every zone configured to require follow-up reporting for reportable events. After the initial reporting task and review is completed, this task will be automatically assigned to the Initial Regulatory Reporter if the event was reportable. The Regulatory Reporter's task is to prepare the follow-up reports for review and submission by the Regulatory Reporting Reviewer for the zone.
The Follow-up Reporting for Zone page allows you to complete and upload any follow-up reporting forms required by the zone. This page is used by the Follow-up Regulatory Reporting and the Review Follow-up Regulatory Reporting tasks.
All reporting information will be shown in the "Reporting Forms" table. Reporting from the Initial reporting step (indicated by a Submission Type of "Initial") will not be editable during follow-up reporting. Forms from the Follow-up step may be edited or deleted up until they are submitted and signed off.
Clicking the "Add Reporting Form" button will take you to the Add/Edit Reporting Form page, which will allow you to upload a follow-up reporting form.
Clicking "Finish Later" will return you to your task list, allowing you to complete the follow-up reporting at a later time.
You can sign off on the task once all necessary reporting forms have been uploaded. Click the "Proceed to Signoff" button to go to the Sign Off Follow-up Reporting for Zone page.
You can sign off on the task once the forms have been reviewed and submitted to the appropriate regulatory agency. Click the "Proceed to Signoff" button to go to the Sign Off Follow-up Submission for Zone page.
The Sign Off Follow-up Reporting for Zone page allows you to sign off once a zone's follow-up reporting has been completed.
Before signing off of the follow-up reporting task, all appropriate follow-up reporting forms should be completed and uploaded. The Regulatory Reporting Reviewer for the zone will review the forms during the Review Follow-up Regulatory Reporting task.
Enter your signoff key and click the "Sign Off" button to sign off the task.
Click the "Cancel" button to return to the Follow-up Reporting for Zone page without signing off on the task.
The Review Follow-up Regulatory Reporting task is assigned when a Regulatory Reporter has finished preparing a complaint's follow-up reports for the regulatory agency in a reporting zone. The task is either assigned to the Regulatory Reporting Reviewer configured for the zone (see Configure Regulatory Reporting Zones), or assigned to the Complaint Module Coordinator if no reviewer has been configured.
The user's task is to review the reports prepared by the Regulatory Reporter, make any changes that are necessary, and send the reports to the appropriate regulatory agency for the reporting zone.
The Follow-up Reporting for Zone page is used perform this task.
The Sign Off Follow-up Submission for Zone page allows you to sign off that you have reviewed, corrected, and sent all follow-up reporting forms for a Complaint to the regulatory agency for the specified reporting zone.
Fill in the actual date that the forms were sent to the regulatory agency for the specified zone, along with any comments you wish recorded about your task of reviewing, correcting, and sending the reports. When you enter your signoff key and click the "Sign Off" button, your changes are recorded, and the Initial Reporting for Zone task is complete and removed from your task list.
If you click the "Cancel" button, your changes are ignored, you are returned to the previous page so you can review or make more changes.
This page allows authorized users to perform administrative actions necessary to manage Issues in the Grand Avenue system.
The page has links to the following actions:
The Reopen Closed Issue feature allows Complaint Module Coordinators to reopen issues previously closed with no further action when changes or additional work are required.
A Reopen Closed Issue task will be recorded in the Task History for the issue, the issue will be reopened with a Status of "Submitted", and a task will be assigned to authorize a user to perform the designated work on the reopened issue.
This page allows you to search for and select a closed issue that needs to be reopened for additional work.
Fill in any applicable search criteria and click the "Search" button to find the desired issue. Then, click the corresponding "Select" button for the issue to proceed to the Reopen Closed Issue page.
You will only be allowed to select issues that are currently closed with no further action required.
Clicking the "Cancel" button will return you to the previous page without selecting an issue.
Select a user to perform the work on the activity, then indicate the date by which the work should be completed and provide any additional instructions as necessary.
Use the "Reason for Reopening Issue" field to record the reason for reopening the issue.
Enter your signoff key and click the "Reopen Issue" button to proceed with reopening the issue.
Clicking the "Cancel" button will return you to the Manage Issues page without reopening the issue.
This task is recorded in the Task History of an issue that is reopened for changes or additional work using the Reopen Closed Issue page.
By default, issues cannot be modified once they have been closed. However, Complaint Module Administrators can set an option on the Configure Complaint Process Options page that allows Complaint Module Coordinators to record additional information for closed issues.
The page displays a list of all complaints that have been closed. To record additional information for a complaint, click its "Record Additional Information" button (see Record Additional Information for Closed Item).
Click the "Close" button to return to the previous page.
The Export Issues feature allows the Complaint Module Administrator to export the metadata and file content for a selected set of Issues to a directory on the web server.
The export will generate a separate directory structure for each selected Issue, which will contain two types of files for each related item:
Click the "Export Issues" link on the Manage Issues page. You will be taken to the Select Issues to Export page, where you can use search criteria to specify the set of Issues that will be included in the export.
This page allows you to select the set of Issues to be included in the export.
Fill in any applicable search criteria and click the "Search" button to find matching Issues.
When the search results display the desired set of Issues, click the "Export Results to Server" link to proceed to the Export Issues to Server page.
Clicking the "Cancel" button will return you to the Manage Issues page.
This page will export the metadata and file content for each Issue that matches the values in the "Search Criteria for Export" table.
The "Search Criteria for Export" table displays the fields and values selected on a Search page, determining which items will be included in the export. NOTE: You can change "Max # of Items to Export", in a field below this table. The export will only contain information about that number of items specified, even if more items matched the specified search criteria. Clearing the value from the "Max # of Items to Export" field will return all items matching the other search criteria.
Use the "File Format" field to indicate the format for the delimited text files.
Use the "List Separator" field to specify the delimiter to be used when exporting the delimited text files using a CSV file format. By default, the delimiter is set to the list separator for your locale, so you should only need to change this setting when exporting a CSV file for a different locale.
Use the "Date Format" field to select the format to be used when exporting date values. By default, the format is set to match the configuration setting for entering and displaying dates in Grand Avenue (see Configure System Date and Time Settings). This feature allows you to specify a different format if exporting to an application like Excel that expects a different format for your region (e.g. en-GB [dd/mm/yyyy] instead of en-US [mm/dd/yyyy]). Using the recommended culture-independent format defined by ISO-8601 (yyyy-mm-dd) will ensure that dates will always be interpreted correctly.
Click the "Export Issues to Server" button to initiate the export process. A successful export will indicate the full path of the export directory created on the web server.
Clicking the "Close" button will return you to the Manage Issues page.
This page allows authorized users to perform administrative actions necessary to manage Complaints in the Grand Avenue system.
The page has links to the following actions:
Manage Approve Closure - used by Complaint Module Coordinators to cancel open Approve Closure tasks for a Complaint.
Reopen Closed Complaints - used by Complaint Module Coordinators to reopen a previously closed Complaint.
Record Additional Information for Closed Complaints - used by Complaint Module Coordinators to record additional information for Complaints that have been closed. This link is only displayed if this option has been enabled (see Configure Complaint Process Options).
Export Complaints - Used by Complaint Module Administrators to export the metadata and file content for a selected set of Complaints to a directory on the web server.
Administrative Update for Complaint Field Values - used by Complaint Module Administrators to make administrative updates to the values to the values of the following fields for existing Complaints:
This page displays the list of Complaints that have open Approve Closure tasks.
Normally the approval of closure for a Complaint is only concluded once all approvers have signed off on their Approve Closure tasks. Complaint Module Coordinators have the option to cancel an approval that is in progress. Any remaining open Approve Closure assignments will be canceled, and the Complaint will return to the Review for Closure task.
To cancel the open Approve Closure tasks for a Complaint, click its corresponding "Cancel Approve Closure" button (see Cancel Approve Closure).
Click the "Close" button to return to the previous page.
Canceling the closure approval for a Complaint will immediately cancel any open Approve Closure task assignments and return the Request to the Review for Closure task, where you will be able to make any necessary changes before submitting it for closure again.
To proceed with canceling the Approve Closure tasks for the selected Complaint, enter the reason for canceling the approval, then enter your signoff key and click the "Cancel Approve Closure" button. Notifications will be sent to all approvers, informing them why the approval was canceled.
Clicking the "Cancel" button will return you to the previous page without canceling the approval for this Complaint.
The Reopen Closed Complaints feature allows Complaint Module Coordinators to reopen previously closed complaints when changes or additional work are required.
A Reopen Closed Complaint task will be recorded in the Task History for the complaint, the complaint will be reopened with a Status of "Processing", and a task will be assigned to authorize a user to perform the designated work on the reopened complaint.
This page allows you to search for and select a closed complaint that needs to be reopened for additional work.
Fill in any applicable search criteria and click the "Search" button to find the desired complaint. Then, click the corresponding "Select" button for the complaint to proceed to the Reopen Closed Complaint page.
You will only be allowed to select complaints that are currently closed.
Clicking the "Cancel" button will return you to the previous page without selecting a complaint.
Select a user to perform the work on the activity, then indicate the date by which the work should be completed and provide any additional instructions as necessary.
Use the "Reason for Reopening Complaint" field to record the reason for reopening the complaint.
Enter your signoff key and click the "Reopen Complaint" button to proceed with reopening the complaint.
Clicking the "Cancel" button will return you to the Manage Complaints page without reopening the complaint.
This task is recorded in the Task History of a complaint that is reopened for changes or additional work using the Reopen Closed Complaint page.
By default, complaints cannot be modified once they have been closed. However, Complaint Module Administrators can set an option on the Configure Complaint Process Options page that allows Complaint Module Coordinators to record additional information for closed complaints.
The page displays a list of all complaints that have been closed. To record additional information for a complaint, click its "Record Additional Information" button (see Record Additional Information for Closed Item).
Click the "Close" button to return to the previous page.
The Export Complaints feature allows Complaint Module Administrators to export the metadata and file content for a selected set of Complaints to a directory on the web server.
The export will generate a separate directory structure for each selected Complaint, which will contain two types of files for each related item:
Click the "Export Complaints" link on the Manage Complaints page. You will be taken to the Select Complaints to Export page, where you can use search criteria to specify the set of Complaints that will be included in the export.
This page allows you to select the set of Complaints to be included in the export.
Fill in any applicable search criteria and click the "Search" button to find matching Complaints.
When the search results display the desired set of Complaints, click the "Export Results to Server" link to proceed to the Export Complaints to Server page.
Clicking the "Cancel" button will return you to the Manage Complaints page.
This page will export the metadata and file content for each complaint that matches the values in the "Search Criteria for Export" table.
The "Search Criteria for Export" table displays the fields and values selected on a Search page, determining which items will be included in the export. NOTE: You can change "Max # of Items to Export", in a field below this table. The export will only contain information about that number of items specified, even if more items matched the specified search criteria. Clearing the value from the "Max # of Items to Export" field will return all items matching the other search criteria.
Use the "File Format" field to indicate the format for the delimited text files.
Use the "List Separator" field to specify the delimiter to be used when exporting the delimited text files using a CSV file format. By default, the delimiter is set to the list separator for your locale, so you should only need to change this setting when exporting a CSV file for a different locale.
Use the "Date Format" field to select the format to be used when exporting date values. By default, the format is set to match the configuration setting for entering and displaying dates in Grand Avenue (see Configure System Date and Time Settings). This feature allows you to specify a different format if exporting to an application like Excel that expects a different format for your region (e.g. en-GB [dd/mm/yyyy] instead of en-US [mm/dd/yyyy]). Using the recommended culture-independent format defined by ISO-8601 (yyyy-mm-dd) will ensure that dates will always be interpreted correctly.
Click the "Export Complaints to Server" button to initiate the export process. A successful export will indicate the full path of the export directory created on the web server.
Clicking the "Close" button will return you to the Manage Complaints page without exporting documents.
The Complaint Handling module provides a Searching capability that allows authorized users to search for information managed by the Complaint Handling process. See Configure Complaint Module Access List for information on configuring the access list that controls authorization for search.
To search for a particular group of issues, click the "Search for Issues" link on the navigation menu (see the Search for Issues page).
To search for a particular group of complaints, click the "Search for Complaints" link on the navigation menu (see the Search for Complaints page).
To search for a particular group of customers, click the "Search for Customers" link on the navigation menu (see the Search for Customers page).
The Search for Issues page allows authorized users to search for Issues managed by Grand Avenue. See the Searching and Reports section for additional information about searching in Grand Avenue.
The page displays a set of criteria that can be used to narrow your search to a particular group of issues.
The Status field allows you to restrict your search to issues that are in a particular stage of the process:
The "Related Complaint / CAPA?" field allows you to restrict your search to issues based on the related Grand Avenue process that was initiated to address the issue (if any):
Use the following date-based search fields to narrow your search to issues that have fields within a specified date range:
When a search is performed, summary information is displayed about each issue matching your search criteria. Click on the "Info" link for a particular issue to see more complete information about that issue.
The Search for Complaints page allows authorized users to search for Complaints managed by Grand Avenue. See the Searching and Reports section for additional information about searching in Grand Avenue.
The page displays a set of criteria that can be used to narrow your search to a particular group of complaints.
The Status field allows you to restrict your search to complaints that are in a particular stage of the process:
The Reportable field allows you to restrict your search for Complaints based on whether or not they were marked as a Reportable Event for the configured Reporting Zones. The following values can be selected:
Use the following date-based search fields to narrow your search to complaints that have fields within a specified date range:
When a search is performed, summary information is displayed about each complaint matching your search criteria. Click on the "Info" link for a particular complaint to see more complete information about that complaint.
The Search for Customers page allows authorized users to search for Customers managed by Grand Avenue. See the Searching and Reports section for additional information about searching in Grand Avenue.
The page displays a set of criteria that can be used to narrow your search to a particular group of customers.
Use the following date-based search fields to narrow your search to customers that have fields within a specified date range:
When a search is performed, summary information is displayed about each customer found. Click on the "Info" link for a particular customer to see more complete information about that customer.
When an organization installs and deploys the Grand Avenue Software Complaint Handling module, there are a number of preliminary configuration steps that should be performed. Each step has its own configuration screen to assist Complaint Module Administrators in getting the system ready for production.
The complaint module allows you to define custom fields for recording and trending additional information about Issues and Complaints. Fields that have been configured to be "Conditionally Required" are optional in the early stages of the Issue and Complaint Processes.
This page guides you through the steps in configuring the Complaint Handling module and can be used as part of your Operational Qualification (OQ) procedures, by printing the checklist/signature version of the page. Perform and initial each step, then sign the page when it is complete.
This page is also used to modify configuration settings as necessary.
The Configure Complaint Module page has links to the following configuration tasks:
The Configure Complaint Process Options page is used by Complaint Module Administrators to tailor the Grand Avenue Software Complaint Handling process to align with the organization into which it is deployed.
The following process options can be configured:
Setting this option to "Yes" will allow Complaint Module Coordinators to record additional information using a link on the Manage Issues page. NOTE: The Manage Issues link in the navigation menu is only displayed if this option is set to "Yes".
Setting this option to "Yes" will allow Complaint Module Coordinators to record additional information using a link on the Manage Complaints page. NOTE: The Manage Complaints link in the navigation menu is only displayed if this option is set to "Yes".
Indicate whether an Issue ID is immediately generated for an Issue when it is first saved.
If this option is set to "No", the Issue ID is not generated until the first time the Issue is submitted to the Review New Issue step.
Indicate whether or not the system requires Patient Affected information to be recorded for Issues. If this option is set to "No", the "Patient Affected?" question will not be displayed when entering new Issues into the system, and will not be available for searching and charting. This option is only intended to be used by organizations that will never use the Patient Affected fields.
Indicate whether Complaint Module Coordinators are required to route Complaints for approval prior to closure. If this option is set to "No", the Complaint is immediately closed when the Complaint Module Coordinator signs off the Review for Closure task.
Indicate whether the Field Action process can be initiated during the Complaint workflow. If set to "Yes", users performing either the Initiate Complaint or Investigate tasks have the option to initiate a Notify Field Action Team task.
If the CAPA module is activated, any CAPA Request initiated for an Issue (see Submit Issue as CAPA) will be populated with information from the Issue (see Integration with CAPA Process). Use the "Source Type for CAPA Request Initiated by an Issue" field to indicate the value that will be used to set the "Source Type" field of the CAPA Request. The Issue will also be added as a "Related Source" for the CAPA Request.
If the CAPA module is activated, any CAPA Request initiated for a Complaint (see Initiate CAPA Process) will be populated with information from the Complaint (see Integration with CAPA Process). Use the "Source Type for CAPA Request Initiated by a Complaint" field to indicate the value that will be used to set the "Source Type" field of the CAPA Request. The Complaint will also be added as a "Related Source" for the CAPA Request.
Click the "Save Configuration" button to apply your changes and return to the Configure Complaint Handling Module page.
Clicking the "Cancel" button will return you to the Configure Complaint Handling Module without saving your changes.
This page allows you to configure the zones that must be considered by the Regulatory Reporting process when handling complaints submitted against your organization's products.
A summary table displays the zones currently defined for your organization.
Click the "Add Reporting Zone" button add a new reporting zone to the list (see Add Regulatory Reporting Zone).
Click the "Edit" button for a reporting zone to update information for that zone (see Edit Regulatory Reporting Zone).
Click the "Delete" button for a reporting zone to remove it from the system. NOTE: You cannot delete reporting zones that are referenced by open complaints. If you first deactivate the reporting zone, it will no longer be referenced by new complaints entering the regulatory reporting process. Then you can delete the zone once all of the existing complaints that referenced the zone have been closed.
If all reporting zones have been deleted from the system, you can use the "Add Default Reporting Zones" button to re-initialize the out-of-the-box zones defined by Grand Avenue Software (United States and European Union).
Click the "Close" button to return to the Configure Complaint page once you have finished configuring the reporting zones.
If you are adding a new regulatory reporting zone, you must enter a unique, descriptive name for the reporting zone (e.g. "United States", "Canada"). NOTE: If you are adding a zone named "United States" or "European Union", the system will automatically configure special "default" user assistance pages for each of the questions. These pages can still be overridden by configuring custom assistance for any of the questions.
Indicate whether or not the reporting zone also requires follow-up reporting for reportable events. If set to "Yes", the user originally assigned to complete the Initial Regulatory Reporting task for the complaint will be assigned a Follow-up Regulatory Reporting task for this zone.
The "Regulatory Reporting Reviewer" field allows you to optionally indicate a user that will be assigned the Review Initial Regulatory Reporting and Review Follow-up Regulatory Reporting tasks for this zone. If you do not specify a user, the tasks will be assigned to the Complaint Module Coordinator.
Indicate whether or not the reporting zone must be considered when determining whether or not a complaint must be reported. If set to "No", this zone will not be included in the list of zones to be considered when the Initial Regulatory Reporting task is initiated.
User Assistance links are provided to help users performing regulatory reporting tasks. The assistance for each of these questions should be tailored for your organization to help the user take the appropriate action for this zone.
Use the "Assistance Type" field for a question to indicate what type of assistance will be provided to the user:
NOTE: When using a Custom URL to display a web page for the User Assistance:
https://www.grandavenue.com/SomeAssistance.htm).Once you have configured the zone, click the "Save" button to save your changes and return to the Configure Regulatory Reporting Zones page.
Click the "Cancel" button to return to the Configure Regulatory Reporting Zones page without saving your changes.
This page allows you to configure the review boards that can be used to review the complaint before closure if configured (see Configure Complaint Process Options).
See the Review Boards topic in the General help section for information about how to add review boards.
Complaint Module Administrators can configure the list of Process Impacts that will be used by Complaints (see Configure Process Impacts for Module).
When a Complaint is first created, a process impact is created for each corresponding process impact definition. As users edit the Complaint, they will be able to review the list of process impacts to consider each for applicability (see Process Impacts). Impact Implementation tasks may be required for each applicable impact that was defined to require an implementation task (see Initiate Complaint).
The following roles can be assigned by Complaint Module Administrators using the Manage Role Assignments page:
See the Manage Role Assignments section in the General help for additional information about assigning roles to users.
By default, all users are authorized to submit and view information for the Complaint Module.
You can control which users are authorized by configuring the Complaint Module Access List.
If a user is restricted from accessing information by the Complaint Module Access List, that user will only be able to view Complaint Module information when they have an authorizing role assignment or open task assignment.
Role assignments and open task assignments can temporarily authorize a restricted user to access information about the item associated with that assignment.
See the Configure Access List section in the General help for additional information about configuring this access list.
Users submitting Issues can indicate whether or not a customer was associated with the issue. The Manage Customers page is used to maintain the list of customers that can be selected. Customers must be added to this list before users will be able to select them.
Complaint Module Administrators and users assigned the Customer Importer role are authorized to use the Manage Customers page.
The Manage Customers page has links to the following actions:
Enter a unique name/ID for the customer, along with the country and address where the customer is located. You can also optionally enter a separate shipping address for a customer, if it is different than the primary address.
To upload a file containing information about the customer, click the "Add Customer Attachment" button. This will save the customer and take you to the Add Customer Attachment page.
Click the "Add Customer" button to save the customer and return to the Manage Customers page.
Clicking the "Cancel" button will return you to the Manage Customers page without adding the new customer.
This page allows you to search for and select a customer to be edited.
Fill in any applicable search criteria and click the "Search" button to find the customer in question. Then, click the corresponding "Select" button for the customer to proceed to the Edit Customer page.
Clicking the "Cancel" button will return you to the previous page.
Update the customer information as necessary.
To upload a file containing information about the customer, click the "Add Customer Attachment" button. This will save the customer and take you to the Add Customer Attachment page.
To edit or delete a previously uploaded attachment, click the corresponding button in the "Customer Attachments" table.
Click the "Save" button to save your changes and return to the Manage Customers page.
Clicking the "Cancel" button will return you to the Manage Customers page without saving your changes.
To upload a file containing information about a customer, enter a brief description of the file and then click the "Browse" or "Choose File" button to find and select the file from your local machine. Once you have identified the file, click the "Save" button to upload the file and return to the Edit Customer page.
If you have chosen to make change to a previously uploaded file, the page will display a link to the current version. You can replace the current version by selecting another file.
Click the "Cancel" button to discard any changes and return to the Edit Customer page.
This page allows you to search for and select one or more customers to be deleted.
Fill in any applicable search criteria and click the "Search" button to find the customers to be deleted.
Use the checkboxes to select the customers to be deleted and click the "Delete Selected Customers" button. The customers will be permanently deleted from the system.
Clicking the "Cancel" button will return you to the previous page.
This page allows you to deactivate one or more customers. Deactivated customers cannot be used when selecting a customer for an Issue.
Fill in any applicable search criteria and click the "Search" button to find the customers to be deactivated.
Use the checkboxes to select the customers to be deactivated and click the "Deactivate Selected Customers" button. The "Is Customer Active?" status for each of the customers will be changed to "No".
Clicking the "Cancel" button will return you to the previous page.
This page allows you to activate one or more previously deactivated customers.
Fill in any applicable search criteria and click the "Search" button to find the customers to be activated.
Use the checkboxes to select the customers to be activated and click the "Activate Selected Customers" button. The "Is Customer Active?" status for each of the customers will be changed to "Yes".
Clicking the "Cancel" button will return you to the previous page.
To import information about multiple customers at once, you must first create a single delimited text file that contains all of the information for those customers. See the instructions below on how to format the input file.
Use the "File Format" field to indicate the format used to create the delimited text file.
If your delimited text file uses the CSV format, specify the List Separator that is used as the delimiter. By default the delimiter is already set to the list separator used by Excel when saving a CSV file for your locale, so you should only need to change this setting when working with a CSV file created by Excel in another locale.
After specifying the File Format for your delimited text file you can click the "Download" link to download a Template Delimited Text File in that format with all of the necessary columns.
Once you have prepared your delimited text file for import, click the "Browse" or "Choose File" button to find and select the file from your local machine, and then click the "Import Customers" button. The system will report the number of customers imported.
If any errors are found in the input file, no customers will be imported and a summary of all the errors will be displayed. Once you have corrected the errors in the input file, you can start the import again by re-selecting the file and clicking the "Import Customers" button.
Click the "Cancel" button to return to the Manage Customers page.
The input file to the import process must be formatted as follows:
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