Defining an Audit Program

Displays the Task Owner and the Due Date. Click the Change Task Owner link to assign this task to another user.

Enter the information in the Audit Program section fields. Some of this information in this section will default from the Initiate Audit Program window.

• Audit Program Type* - This field defaults from the Initiate Audit Program window.
• Initiating Site* - Zoom to select a site. The site selected defines the audit program team associated with the new Audit Program record. For information on configuration, see Organization Units.
• Audit Program Start Date - Zoom to select an audit program start date.
• Audit Program End Date - Zoom to select an audit program end date.
• Audit Program Title* - Enter a name for the audit program. This field defaults from the Initiate Audit Program window.
• Audit Program Description - Enter a description of the audit program.

Planned audits are defined as part of an audit program and are used by the business to plan for and conduct each specific audit that needs to occur. Click the Add Planned Audits link and then enter the information in the first section.

NOTE: Click the Copy link to duplicate an already entered planned audit to save time. A duplicate planned audit will be inserted below the original planned audit in the Planned Audits section.

• Auditee* - Zoom to select an auditee. Click the View link to access the Auditee record for viewing or editing. If the auditee selected is a supplier, there will be an Auditee Detail link to allow the user to view the supplier information.For information on configuration, see Auditees.
  
• Auditee Type - This field is automatically populated when the auditee is selected.
• Audit Type* - Click the drop down button and select the type of audit, such as Regulatory or Supplier. The audit type dictates the Audit Program and Audit numbering scheme. The audit type defaults from the audit program type. For information on configuration, see Audit Types.
  
• Audit Sub-Type - Click the drop down button and select the sub-type of audit. This field is used to further clarify the type of audit. For information on configuration, see Sub Types.
• Primary Contact* - Enter or zoom to select the client/actor associated with the auditee. This field defaults from Auditee Setup. For information on configuration, see Users.
• Trial - Enter or zoom to select the name of the clinical trial. This field is only displayed if the Audit Type is Clinical Trial. For information on configuration, see Trials.
• Phase - Zoom to select the phase. This field is only displayed if the Audit Type is Clinical Trial. For information on configuration, see Phases.
• Quarter - Click the drop down button and select the quarter in which the audit will take place. For information on configuration, see Quarters.
• Year - Enter the Year in which the audit will take place.
• Planned Start Date - Zoom to specify the date when the audit will start. Click the Verify Schedule link to view a conflict report of all planned audit resources, such as the schedules for the auditee and lead auditor. If a planned start date and end date are entered, then the conflict report displays the schedules between those dates. This link is for planned audits that are not in Void or Closed status.
• Planned End Date - Zoom to specify the date when the audit will end.
• Auditee as Finding Approver - Select Yes if the auditee is also a finding approver in addition to the approver selected in the audit team.
• Planning Complete* - Select Yes to include this planned audit in the approval process once the audit program is signed off. At least one planned audit must be marked as Planning Complete for the audit program to be submitted for approval.
• Auditee as Response Approver - Select Yes if the auditee is also a response approver in addition to the approver selected in the audit team.
• Title* - Enter a unique name for the audit.
  
• Description/Purpose - Enter a description of the planned audit.
• Scope - Define the scope of the planned audit.

Several different user roles are involved in the audit program process. Customers must configure their own roles to be used with the system. The following tasks (role) have been configured as defaults in the Audit Management application.

• Lead Auditor - A lead auditor must be selected. The lead auditor is responsible for performing audits, documenting audit findings and/or observations, reviewing audits, and preparing audit reports.
• Auditor - The auditor is responsible for performing audits, documenting audit findings and/or observations, and preparing audit reports.
• Finding Review - Finding review is an optional task (if the Perform Finding Review policy is set to Yes) in the Audit record and is typically performed by the lead auditor. If the Perform Finding Review policy is enabled, then a reviewer must be selected. Only one finding reviewer can be defined.
• Finding Approval - Finding approval is an optional task (if the Perform Finding Approval policy is set to Yes) in the Audit record and is typically performed by the primary contact and lead auditor. If the Perform Finding Approval policy is enabled, then an approver must be selected. Only one finding approver can be defined.
• Findings Response Approval - Finding response approval is a required task in the Audit record.
• Completion Review - Completion review is a required task in the Audit record. Only one completion reviewer can be defined.
• Effectiveness Review - Effectiveness review is a required task in the Audit record. Only one effectiveness reviewer can be defined.
• Verify Implementation - Implementation verification is a required task in the Audit record. Only one verifier can be defined.

Click the Add Site link to add another site to the auditee. Enter the information in the following Site section fields:

• Site - Enter or zoom to select the site to add to the auditee. If a valid auditee has been selected, then the options in this field default to the sites identified for the selected auditee in Auditee setup. For information on configuration, see Organization Units.
• Department - Enter or zoom to select the department associated with the auditee. If a valid auditee and site have been selected, then the department options displayed in this field are from Auditee setup based on the selected site. For information on configuration, see Organization Units.
• Contact - Enter or zoom to select the contact associated with the auditee. If the department has been selected, then this field defaults to the contact person identified in Department setup. For information on configuration, see Users.

Click the Add Process link to add another process to the auditee. Enter or zoom to select a process(operation) associated with the auditee. The options displayed in the zoom window are defaulted to those set up for the selected site. Multiple processes can be selected. For information on configuration, see Process Setup.

Click the Add Product link to add another product to the auditee. Enter or zoom to select a product associated with the auditee. The options displayed in the zoom window are defaulted to those set up for the selected site. Multiple products can be selected. For information on configuration, see Product Setup.

Click the Add Criteria link to add a criteria to the section. Enter the information in the following Criteria section fields:

• Criteria Number - Enter or zoom to select the criteria number to add to the auditee. The Criteria Title defaults from and displays once the Criteria Number is selected. For information on configuration, see Criteria Setup.
• Section Number - Click the drop down button and select the number of the section for the criteria. The Section Title defaults from and displays once the Section Number is selected. Choose specific sections from the criteria to include or leave the section blank to use all of the criteria sections.

Click the Add Document link to attach a document to the criteria. Enter the information in the Document section fields:

• Document Number* - Zoom to select a document from the SmartDoc system. If SmartDoc is not installed, then enter a reference number for an external document. Forms Designer can be used to configure this field to link to an external document system. See the Studio Designer Help System for additional information.
• Document Revision - Enter the referenced document's revision number.
• Title - Enter the title of the document.

Click the Add Team Member link to add an external team member to the section. Enter the information in the following External Audit Team section fields:

• Name* - Enter or zoom to select the external team member for the planned audit.
• Phone Number - Enter a phone number for the team member.
• E-mail - Enter an e-mail address for the team member.

Policies control the optional steps that can be performed in your audit program workflow. An administrator can set these controls and restrict your users from selecting or changing these options. Enter the information in the following Policy section fields.

• Perform Audit Program Review?* - Select Yes if you want the audit program to be reviewed. The default setting is set to No for this policy. If No is selected, then audit program review will be skipped for this record. If Yes is selected, then a Audit Program Reviewer is required in the Audit Program Team section.
• Perform Audit Program Approval?* - Select Yes if you want to require approval of the audit program. The default setting is set to Yes for this policy. If No is selected, then approval will be skipped for this record. Audit program approval is an optional task and takes place after the audit program is reviewed. If Yes is selected, then an Audit Program Approver is required in the Audit Program Team section.
• Reroute for Approval on Change* - Select Yes and then specify the changes that will require that the Planned and Confirmed audits be rerouted for approval.
• Audit Planned Start Date Outside Tolerance of - If this checkbox is checked, if the audit start date is changed to date that is greater than the tolerated number of days, the audit program will be rerouted for approval. Specify the number of days that will be tolerated before the audit program will be rerouted for approval.
• Auditee - Check this box if a change to the auditee will require that the audit program be rerouted for approval.
• Lead Auditor - Check this box if a change to the lead auditor will require that the audit program be rerouted for approval.

Several different user roles are involved in the audit program process. Customers must configure their own roles to be used with the system. The following tasks (roles) have been configured as defaults in the Audit Management application.

• Ownership* - Ownership is a required task in the Audit Program record. The owner of the record is not assigned any task other than ownership. Only one owner can be defined. If an owner is not defined, then owner defaults to the logged in user.
• Audit Program Review - Audit Program review is an optional task (if the Perform Audit Program Review policy is set to Yes) in the Audit Program record and is typically performed by the audit coordinator or lead auditor. If the Perform Audit Program Review policy is enabled, then a reviewer must be selected. Only one audit program reviewer can be defined.
• Audit Program Approval - Audit program approval is an optional task (if the Perform Audit Program Approval policy is set to Yes) and takes place after the audit program is reviewed. If the Perform Audit Program Approval policy is enabled, then an approver must be selected.
• Audit Program Closure - If Perform Auto Close is set to No, then a closure approver must be selected.

NOTE: If the role is defined as not required in Group Setup, then the Role and Task fields are editable.

If needed, the audit coordinator can add attachments prior to signing off the audit program.