The Grand Avenue Software Audit Management module allows a company to manage the process of planning and executing audits.
Audit Module Administrators are responsible for using the Configure Audit Templates page to define the set of standard templates that are available for Audit Managers to use when preparing the requirements checklist for a new audit (see Import Audit Requirements from Templates).
Audit Module Coordinators are responsible for using the Define Audits page to create Audits that correspond with an organization's audit schedule. The assigned Audit Manager for an audit is responsible for coordinating all work on the audit and can reassign and change the due dates for task assignments associated with the audit. As soon as an Audit has been created, the assigned Audit Manager can begin preparing for the audit using the "Manage Audit" action on the My Audits page.
The Audit Manager for an audit is responsible for defining the list of requirements that will be evaluated during the execution of the audit. The Manage Audit page is used by the Audit Manager to either add specific requirements or import a list of requirements from a template or external file.
During the execution of an audit, the Audit Manager uses the Manage Audit page to record the results and any corresponding findings for each of the requirements. The Audit Manager is also responsible for recording any audit actions taken and any CAPA Requests initiated to address specific findings.
The Audit Manager can authorize other users to assist in this phase of the audit by assigning them Audit Collaboration Tasks. Users assigned one of these tasks can record findings and actions for an audit but are not authorized to add to or modify the requirements of the audit.
As findings and actions are recorded for an audit, the Audit Manager can request feedback from reviewers using the Request Audit Findings Review page. Each of the assigned users receives a Review Audit Findings task that allows them to quickly review the findings and proposed actions, and send comments back to the Audit Manager.
Once results and actions have been recorded for all requirements in an audit, the Audit Manager closes the audit using the Close Audit page.
This page allows authorized users to perform administrative actions necessary to manage audits in the Grand Avenue system.
The page has links to the following actions:
This page allows Audit Module Coordinators to manage the audits for an organization.
The "Open Audits" table contains a list of all audits that have not been closed.
The "Closed Audits" table contains a list of all audits that have been completed and closed. These audits can no longer be edited or deleted.
Click the "Close" button to return to the previous page.
Specify the Audit Type for this audit. This may only be changed while the Audit is open without any findings specified. The Audit Type will be used to specify the source type when creating CAPA Requests from this audit. The possible values for the Audit Type are:
Set values for any custom fields that have been defined by your organization. Fields will only be displayed if they have been configured.
Enter a brief description for this audit, assign an Audit Manager and specify the planned start date.
You should use the "Status" field to indicate to users what state the audit is currently in. The following values are available, and each organization can define in their process how best to use them:
NOTE: The values for the "Status" field have no direct impact on activities that can be performed for the audit. For example, users can still perform tasks and upload results for an audit with an "On Hold" status.
Click the "Save" button to save the audit and return to the Define Audits page. If the Audit Manager has been newly assigned for this audit, they will receive an email notifying them about this audit.
Clicking the "Cancel" button will discard your changes and return you to the Define Audits page.
This page displays a list of all Audits that have been closed.
By default, Audits cannot be modified once they have been closed. However, Audit Module Administrators can set an option on the Configure Audit Process Options page that allows Audit Module Coordinators to record additional information for closed Audits.
To record additional information for an Audit, click the corresponding "Record Additional Information" button (see Record Additional Information for Closed Item).
Click the "Close" button to return to the previous page.
When reopening a previously closed audit, you have the opportunity to make changes to the basic information about the audit (see the Edit Audit page for details on what can be changed).
Before reopening the audit you must select a new "Status" for the audit, and provide a "Reason" for why the audit is being reopened. The reason will be recorded in a Reopen Closed Audit entry in the Task History of the newly added phase.
Click the "Reopen Audit" button to save your changes and reopen the audit. The selected Audit Manager for the audit receive an email notifying them that it has been reopened. You will be taken back to the Define Audits page.
Clicking the "Cancel" button will discard your changes and return you to the Define Audits page.
This task is automatically recorded in the Task History for an audit when a closed audit is reopened by an Audit Module Coordinator (see Reopen Closed Audit).
This page displays all open audits for which you are the Audit Manager (assigned by an Audit Module Administrator using the Define Audits page). Once an audit has been closed (see Close Audit), it will no longer appear in this list.
Click the "Manage Audit" button for an audit to go to the Manage Audit page where you can update its requirements and findings.
Click the "Info" link for an audit to open a separate page where you can view all details about the audit.
This page allows the assigned Audit Manager to define the requirements that will be used for an audit and record the results of the audit.
Each Audit has an official Start Date and End Date for the evidence gathering period. Each Audit also has an Audit Summary field to record a high-level summary of the results of the audit.
The Audit Manager can click the "Edit Audit Information" button update any of these fields (see Edit Audit Information).
The following links provide different views of the audit information:
Click the "Finish Later" button to return to the My Audits page.
Requirements that have been added to the audit are organized by Category into separate tabs. Within each tab, the requirements are organized into separate tables for each distinct Subcategory. Each table displays the following information for requirements:
The Audit Manager can click the "Add Requirements" button to add requirements to the audit (see Add Audit Requirements).
To add a requirement for a specific Subcategory, the Audit Manager can click the "Add Requirement to Subcategory" button below the table for that Subcategory (see Add Audit Requirement).
To make changes to a requirement including the result, resources reviewed and any resulting findings, click the corresponding "Edit" button (see Edit Audit Requirement).
To remove a requirement from the audit, the Audit Manager can click the corresponding "Delete" button.
The Audit Manager can authorize other users to assist in the execution of an audit by assigning them Audit Collaboration Tasks. Users assigned one of these tasks can use the Manage Audit page to record findings and actions but are not authorized to add to or modify the requirements of the audit.
For a complete list of the actions that can be performed by a user assigned one of these tasks, refer to the Audit Collaboration Tasks (#AuditAuditCollaborationTasks) page.
The "Audit Collaboration Tasks" table displays the list of tasks that have been assigned for this audit.
When findings and actions are recorded for an audit, the Audit Manager can click the "Request Audit Findings Review" button to request feedback on the findings from a review team (see Request Audit Findings Review). The "Review Audit Findings Tasks" table will display the status and results of each assigned task.
Once the audit has been completed, the Audit Manager can click the "Close Audit" button to record any final comments and close the audit (see Close Audit). An audit can be closed when:
Once an audit has been closed, you will no longer be able to make changes.
Enter the start and end dates for the evidence gathering period for the audit.
You should use the "Status" field to indicate to users what state the audit is currently in.
The following Status values are available, and each organization can define in their process how best to use them:
Use the "Audit Summary" field to record a high-level summary of the results of the audit. This field can also be used to record additional information discovered during the audit that is not associated with any specific finding (e.g. conclusions about the audit process, areas of excellence, etc.).
Use the "Audit Attachments" table to upload any additional files that contain information related to the overall audit (e.g. meeting minutes, scope statement, etc.).
Click the "Save" button to save your changes and return to the previous page.
Click the "Cancel" button to discard your changes and return to the previous page.
To upload a file as an attachment for an audit, 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 previous page.
If you have chosen to make changes 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 and then clicking the "Save" button to save your changes.
Click the "Cancel" button to discard any changes and return to the previous page.
The Audit Manager for an audit can authorize other users to assist in performing the audit by assigning them Audit Collaboration Tasks. These tasks are assigned from the Manage Audit page (see Assign Audit Collaboration Task).
Users assigned this task for an audit can perform the following actions from the Manage Audit page:
Provide detailed instructions to the assignee of this collaboration task, and then select an assignee and a due date for the task.
Click the "Assign Task and Close" button to assign the task. The system will notify the assignee via email of their assignment, and you will be taken back to the Manage Audit page.
Click the "Assign Task" button to assign the task and remain on this page to assign another collaboration task.
Clicking the "Cancel" button will return you to the Manage Audit page without assigning the task.
To sign off your collaboration task, enter any additional comments about the task and then enter your signoff key. Then click the "Sign Off" button to sign off the task. The Audit Manager for this audit will receive an email notification that you have completed the task.
Clicking the "Cancel" button will return you to the previous page without signing off the task.
This page allows you to add requirements to an audit or audit template.
Click the "Add Requirement" button to enter information for one new requirement (see Add Audit Requirement).
Click the "Import from Templates" button to import requirements from one or more predefined templates (see Import Audit Requirements from Templates).
Click the "Import from File" button to import requirements from a delimited text file (see Import Audit Requirements from File).
Click the "Cancel" button to return to the previous page without adding requirements.
This page allows you to import requirements into your audit from templates defined by Audit Module Administrators (see Configure Audit Templates).
When importing requirements from templates, all requirements must have a unique "Requirement ID". If the templates you have selected contain requirements with duplicate IDs, an error message will tell you which template contains the duplicate and nothing will be imported.
Use the checkboxes to select one or more templates from the "Audit Templates" table, then click "Import Requirements from Selected Templates" button to import the requirements from those templates into your audit. You will then return to the Manage Audit page, where you can review the requirements that were imported.
Click the "Cancel" button to return to the Manage Audit page without importing requirements.
To import information about multiple requirements at once, you must first create a single delimited text file that contains all of the information necessary to define the requirements. 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 your file for uploading, and then click the "Import Audit Requirements" button. If the import is successful, the system will report the number of requirements that were imported.
If any errors are found in the input file, no requirements 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 Audit Requirements" button again.
Click the "Cancel" button to return to the previous page.
The input file to the import process must be formatted as follows:
Categories are used to organize similar requirements in an audit or audit template. Subcategories are used to organize similar requirements within a Category.
Select a category and subcategory for the requirement.
Enter an ID and a description for the requirement. The ID for each requirement must be unique within an audit or audit template.
Use the "Requirements Addressed" field to optionally identify any related requirements in industry standards or company procedures that are addressed by this audit requirement. For example, if this is intended to address a requirement from the ISO 13485 standard, you could record the section of the standard that is addressed (e.g. ISO 13485 (5.3)).
Use the "Tips for Auditor" field to optionally provide suggestions to assist the auditor in determining conformance with this requirement (i.e. what to look for and how).
When you are ready to record the results of the audit for this requirement, start by indicating whether the requirement was found to be Conforming or Nonconforming. If the requirement is not applicable to this audit, you can instead select "N/A" for the Result.
Use the "Evidence / Resources Reviewed" field to record any evidence gathered or resources reviewed to determine conformance with the requirement (e.g., individuals interviewed, documents/records reviewed, etc.).
You can also attach documentation corresponding to the evidence or resources reviewed. The "Attachments for Evidence / Resources Reviewed" table displays this documentation.
The Findings table allows you to record specific findings for the requirement.
When you have finished editing this requirement, click the "Save" button to save your changes and return to the previous page.
Click the "Cancel" button to discard your changes and return to the previous page.
To upload a file as evidence or a resource reviewed for a requirement, 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 Audit Requirement page.
If you have chosen to make changes 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 and then clicking the "Save" button to save your changes.
Click the "Cancel" button to discard any changes and return to the Edit Audit Requirement page.
This page allows you to search for and select a document revision that will be referenced as evidence or a resource reviewed for a requirement.
Fill in any applicable search criteria to identify the document revision to reference. By default, the search criteria are set to only return document revisions with a Status of "Pending Effective" or "Effective", but this can be changed to include other revisions that have been released.
Click the "Search" button to find matching document revisions. Then, click the corresponding "Select" button for the desired document revision to add a reference to the deliverable and return to the Edit Audit Requirement page.
Click the "Cancel" button to discard any changes and return to the Edit Audit Requirement page.
Select the type of finding and enter a description. For assistance in determining the correct type for the finding, click the "Which type should I select?" link.
If this finding should be addressed by a CAPA Request, you can either:
The Audit Actions table allows you to record additional actions to address this finding that do not require a root-cause analysis.
Click the "Save" button to save your changes and return to the previous page.
Click the "Cancel" button to discard your changes and return to the previous page.
Enter a description of the action performed for the finding. You can optionally upload a file by clicking the "Browse" or "Choose File" button to find and select the file from your local machine. If you are making a change to an existing action, you can replace a file that was previously uploaded by selecting another file.
Click the "Save" button to save the action and return to the previous page.
Click the "Cancel" button to discard any changes and return to the previous page.
The Existing CAPA Requests table displays all CAPA Requests currently associated with this audit. However, you can only select CAPA Requests that you are still in the process of submitting for this audit. Once you have submitted a CAPA Request to the CAPA Module Coordinator it can no longer be selected.
Click the "Select" button for the CAPA Request that should be associated with this finding. The system will create an association between the finding and the CAPA Request, and you will be taken to the Edit CAPA Request page. The request will already be populated with information from an earlier finding, so you should review all information and make any necessary updates to reflect the addition of this finding. The "Related Sources" table will display the list of all findings that have been associated with this CAPA Request.
Click the "Cancel" button to discard any changes and return to the previous page.
This page allows the Audit Manager to request feedback about findings.
Assign users to review the audit findings and specify the date by which they should provide their feedback.
Use the "Instructions" field to help the reviewers understand what they should review and provide feedback about.
Click the "Assign Tasks" button to create Review Audit Findings tasks for each of the specified users. You will be returned to the Manage Audit page where you will be able to monitor the status of the reviewers.
Click the "Cancel" button to return to the previous page without initiating a review.
The Review Audit Findings task authorizes you to review and provide feedback about the findings for a specific audit. Instructions from the Audit Manager will guide you on what to review.
The task page displays a summary of the findings, organized into separate tables for each type (Major Nonconformance, Minor Nonconformance and Observation). Each table displays the following information for the findings:
Click the corresponding "Info" link for a finding to view more detailed information.
Once you have completed your review of the findings, click the "Proceed to Signoff" button to advance to the Sign Off Review Audit Findings page, where you will be able to record your comments and sign off on the task.
Clicking the "Finish Later" button will return you to the "My Tasks" page without signing off on the task.
Use the "Comments" field to record your feedback about the findings for this audit. Then enter your signoff key and click the "Sign Off" button to sign off on the task. The Audit Manager will be able to review your feedback using the Manage Audit page.
Click the "Cancel" button to return to the previous page without saving your comments or signing off on the task.
Once an audit has been completed, the Audit Manager is responsible for closing the audit. The Status of the audit will be changed to "Closed" and it will no longer appear in your My Audits page. Once an audit has been closed it can no longer be edited.
An audit must be completed before it can be closed. See the Manage Audit page for a list of what must be completed prior to closing an audit.
Enter any final comments and your signoff key, and then click the "Close Audit" button to close the audit. Your comments will be recorded in a Close Audit entry in the Task History for the audit and you will be returned to the My Audits page. Any Review Audit Findings tasks that are still In Progress will be automatically canceled.
Click the "Cancel" button to return to the previous page without closing the audit.
This task is automatically recorded in the Task History for an audit when it is closed by the Audit Manager (see the Close Audit page).
The Audit module provides a searching capability that allows any user to find and view audits that match specified search criteria. For example, a user can search for all internal audits that are planned within the current year.
To search for a particular group of audits, click the "Search for Audits" link on the navigation menu (see the Search for Audits page).
The Search for Audits page allows authorized users to search for audits 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 audits.
The "Status" field allows you to restrict your search to audits that are in a particular stage of the audit process. The following values are available, and each organization can define in their process how best to use the "Open" status values:
Use the following date-based search fields to narrow your search to audits that have fields within a specified date range:
When a search is performed, summary information is displayed about each audit matching your search criteria. Click on the "Info" link for a particular audit to see more complete information about that audit.
This page displays a list of the requirements for an audit, intended to be printed out as an offline checklist for use when an auditor is performing the audit.
For each requirement the checklist includes the ID, Description, Requirements Addressed and Tips for Auditor. Blank spaces are provided for the following information to allow the auditor to record what they find during the audit, and then later enter that information into the system using the Manage Audit page:
NOTE: These fields are intended to be filled out outside of the system, will be shown as blank regardless of whether or not values have been entered in the software.
When printing the checklist, it is recommended that you change the printer settings to accommodate the width of a Requirements table on a single page:
NOTE: When experimenting with printer settings you may want to only print the first page, rather than the entire checklist.
Click the "Close" button to close the window once you have finished printing the checklist.
This page displays a summary of all of the findings for an audit.
The findings are organized into separate tables for each type (Major Nonconformance, Minor Nonconformance and Observation). Each table displays the following information for the findings:
Click the corresponding "Info" link for a finding to view more detailed information.
Click the "Close" button to close the window.
When an organization installs and rolls out the Grand Avenue Software Audit Management module, there are several preliminary configuration and boot-strapping steps that should be performed. Each step has its own configuration screen to assist the Audit Module Administrators in getting the system ready for production.
This page guides you through the steps in configuring the Audit Management 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 Audit Management Module page has links to the following configuration tasks:
The Configure Audit Process Options page is used by Audit Module Administrators to tailor the Grand Avenue Software Audit 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 Audit Module Coordinators to record additional information using the Record Additional Information for Closed Audits link on the Manage Audits page.
If the CAPA module is activated, any CAPA Request initiated for an Audit Finding for an External Audit (see Add/Edit Audit Finding) will be populated with information from the Audit (see Integration with CAPA Process). Use the "Source Type for CAPA Request Initiated by an External Audit" field to indicate the value that will be used to set the "Source Type" field of the CAPA Request. The Audit and the Audit Finding will also be added as "Related Sources" for the CAPA Request.
If the CAPA module is activated, any CAPA Request initiated for an Audit Finding for an Internal Audit (see Add/Edit Audit Finding) will be populated with information from the Audit (see Integration with CAPA Process). Use the "Source Type for CAPA Request Initiated by an Internal Audit" field to indicate the value that will be used to set the "Source Type" field of the CAPA Request. The Audit and the Audit Finding will also be added as "Related Sources" for the CAPA Request.
If the CAPA module is activated, any CAPA Request initiated for an Audit Finding for a Supplier Audit (see Add/Edit Audit Finding) will be populated with information from the Audit (see Integration with CAPA Process). Use the "Source Type for CAPA Request Initiated by a Supplier Audit" field to indicate the value that will be used to set the "Source Type" field of the CAPA Request. The Audit and the Audit Finding will also be added as "Related Sources" for the CAPA Request.
Click the "Save Configuration" button to apply your changes and return to the previous page.
Clicking the "Cancel" button will return you to the previous page without saving your changes.
The following roles can be assigned by Audit 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 view information for the Audit Management Module.
You can control which users are authorized by configuring the Audit Management Module Access List.
If a user is restricted from accessing information by the Audit Management Module Access List, that user will only be able to view information for open Audits, and only when:
See the Configure Access List section in the General help for additional information about configuring this access list.
This page allows Audit Module Administrators to define the standard templates that can be used by Audit Managers in defining the requirements for an audit (see Import Audit Requirements from Templates).
The "Audit Templates" table contains a list of the templates that have already been defined.
Click the "Close" button to return to the Configure Audit Management Module page.
Enter a unique name and a description for the template. The description should provide enough information to allow an Audit Manager to determine if this template is appropriate for their audit.
Click the "Save" button to save the template and return to the Configure Audit Templates page.
Click the "Add Requirements" button to add requirements to the template (see Add Audit Requirements).
Clicking the "Cancel" button will discard your changes and return you to the Configure Audit Templates page.
Requirements that have been added to the audit are organized by Category into separate tabs. Within each tab, the requirements are organized into separate tables for each distinct Subcategory. Each table displays the following information for requirements:
To add a requirement for a specific Subcategory, click the "Add Requirement to Subcategory" button below the table for that Subcategory (see Add Audit Requirement).
To make changes to a requirement, click the corresponding "Edit" button (see Edit Audit Requirement).
To remove a requirement from the template, click the corresponding "Delete" button.
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