Electronic IQ Training

Learning Curve Training Self-Study Course

Electronic IQ Training
Contents
Introduction ................................................................................................................................................................4 Managing Approved Installation Qualifications (AIQs) ..............................................................................................5 Creating a new IQ Template ...................................................................................................................................5 IQ Template Entry Screen Section 1 ....................................................................................................................6 System and Version Information ........................................................................................................................7 Product Category and Compliance Factors ........................................................................................................7 Approval Chain ...................................................................................................................................................7 Revision History ..................................................................................................................................................8 IQ Template Entry Screen Section 2 ....................................................................................................................8 Overview.............................................................................................................................................................9 System Information ............................................................................................................................................9 Installation Location and Environment Verification ...........................................................................................9 Instructions to the Installer ................................................................................................................................9 Acceptance Criteria ............................................................................................................................................9 Instructions for Resolving Errors ........................................................................................................................9 Uninstall Procedures ..........................................................................................................................................9 IQ Template Entry Screen Section 3 ................................................................................................................. 10 Installation Procedures.................................................................................................................................... 10 IQ Template Steps ........................................................................................................................................... 10 IQ Template Step Screen ................................................................................................................................. 12 Inserting a Step ................................................................................................................................................ 13 Lifecycle Dates ................................................................................................................................................. 13 Activity ............................................................................................................................................................. 14 IQ Variables ..................................................................................................................................................... 14 IQ Template Entry Screen Section 4 ................................................................................................................. 14 Approvals ......................................................................................................................................................... 15 IQ Template Appendices ................................................................................................................................. 15 Requesting AIQ Approval .................................................................................................................................... 17 Adding Document Revisions ................................................................................................................................ 19 Managing Executed Installation Qualifications (EIQs) ............................................................................................ 20 13 Dec 2012 Page 2

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Creating a new EIQ .............................................................................................................................................. 20 Executing an EIQ .................................................................................................................................................. 22 Creating an Error Log ........................................................................................................................................... 23 Resolving an Error Log ......................................................................................................................................... 24 Requesting EIQ Approval ..................................................................................................................................... 25

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Introduction
In December 2012, Global IT launched the Electronic Installation Qualification (IQ) process. This allows for the creation and execution of IQs, both Infrastructure and A/B Categories, within Service-Now. The system has been designed based on the current templates and includes workflows for obtaining pre- and post-execution approvals. The benefits of the electronic IQ process are: Complete retirement of paper-based IQs Productivity improvements in reduction of time to prepare documents and obtain signatures Centralized management of IQs for audits IQs linked to Change Requests in Service-Now What this means for you: If you are an author, installer or approver, you will only receive access to the IQ functionality once you have completed training. Access will be provided beginning January 10, 2013. Through January 31, 2013, paper -based or the new process will be acceptable forms of delivery for IQs. Beginning February 1, 2013 all IQs must be created and executed utilizing the IQ process in Service-Now. You will need to acknowledge CS_WI_IT219 - SLC - Configuration and Release Management and CS_OP_IT029 - SLC - Validation Activities and Deliverables when they are updated in early 2013.

This self-study training provides the detailed steps needed to create and execute IQs in Service-Now. After completing this training, you should be able to: Create an IQ Template Create an IQ Appendix Request IQ approval (pre- and post-execution) Provide IQ Approval (pre- and post-execution) Generate an IQ for execution Execute an IQ Create an error log Resolve an error log

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Managing Approved Installation Qualifications (AIQs)
Creating a new IQ Template
Lauch Service-Now. In the left navigation panel, expand Installation Qualifications. Click on the Create New Template link.

Select the appropiate cateogry for the IQ.

Details about system categories can be found in CS.OP.IT029.

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NOTE: For categories 2, 3, 4 and 5, you will be promtped to enter the regulatory controls for the system.

Select the appropriate options Click on the Create IQ button to proceed to the IQ template entry screen.

IQ Template Entry Screen Section 1

Section 1 of the IQ Template entry screen allows you to enter general system information and the necessary approval chain. Some information will be defaulted by the system or completed based on previous input.

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System and Version Information

When creating a new IQ, the Number and Status fields will be populated by the system. The initial status of the IQ will be Draft. Other statuses include, Pending Approval, Published, Superseded, and Retired. Enter the Product Name and Version Number. If the same AIQ will be used for multiple system versions, use a placeholder (i.e., XX.XX.XX) for the Version Number. The specific system version number can be assigned in the EIQ.

Product Category and Compliance Factors

The IQ Date, IQ Version, and Category fields will be populated by the system. See page 17 for additional information regarding document versions. The Part 11 and SOX checkboxes will be completed for Cat 2, 3, 4, and 5 systems based on the answers provided on the previous screen. Select the appropriate radio button for Hardware or Software.

Standard Service-Now features: o Required fields are preceded by a red bar (changes to green when a value is entered) System generated fields are preceded with a yellow bar Click on the magnifying glass to display a lookup list Hover over the info icon to display details of the value entered

o o o

Approval Chain

The Author field will be pre-populated. Enter the appropriate resource for each approval.

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Cat 1 Cat 2 and 4 The list of approvers will depend on the IQ category. Approver Technical Approver IT Manager Development Manager Technical Approver Qualification Coordinator Technical Approver Qualification Coordinator Development Manager Technical Approver Qualification Coordinator Required? Yes Yes Optional Yes Yes Yes Yes Yes Yes Yes

Cat 3 Cat 5

Revision History

The Revision History information will be maintained by the system.

IQ Template Entry Screen Section 2

Section 2 of the IQ Template Entry Screen is used to enter additional information regarding the system. This content is based on the sections of the existing paper-based IQ template.

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Overview The Overview section contains a link to standard text regarding the IQ. System Information Describe the system that is being installed. Include all of the information that is important for understanding the system/application being installed. For example: o Intended purpose o The scope of the installation -(site, regional, global) o Impact on other IQs o List specific workstations/servers if needed for clarification Installation Location and Environment Verification
A multi-function editor is provided for a number of fields in this section. Features include Font style and size Bold, italics, and underline Justification Bullets and numbering Text and background color Insert web links, pictures, and videos Insert tables and horizontal rules Spell check Resizable text window

Include text to answer each question being as specific as possible. Provide information as if you were reproducing the location and environment into which the system is being installed. o What business group/department is responsible for the installation of this system? o What site preparation is needed for this installation? Consult with the Technical o What software preparation is needed for this installation? Reviewer if more o What interface preparation is needed for this installation? information about location o What data preparation is needed for this installation? (e.g., patient or environment is needed. data, metadata setup, project-specific data, pre-loaded data necessary to install test user accounts, configuration settings) o Is this to be a multi-component installation (i.e., a single IQ or a series of related IQs)? If yes, describe. o What access rights are necessary to perform this installation?(e.g., OS or database admin privileges)

Instructions to the Installer This section contains a link to standard text regarding the instructions for the installer. Acceptance Criteria Enter the criteria for whether the system is ready for installation into the test or production environment. Instructions for Resolving Errors This section contains a link to standard text regarding the instructions for resolving errors. Uninstall Procedures All IQs require a procedure to uninstall the system in the event that the system either does not install as expected, or the system causes unpredicted conflicts and errors. o The uninstall procedures may be as simple as Run the uninstall program. o If the uninstall process is complicated or requires many steps, a separate IQ for the uninstall may be appropriate. Should it become necessary to back out of the installation process or to revert to the previously installed version of the installed system, the following procedure should be followed.

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IQ Template Entry Screen Section 3
Section 3 of the IQ Template Entry Screen is used to enter additional information regarding the system. This content is based on the sections of the existing paper-based IQ template.

Installation Procedures Enter the following information: Test Case Number Test Case Title Test Objective Dependencies for this IQ Starting Point for the installer

Note: Only one test case can be created for each IQ. In order to segment the IQ, use the Comment step type described below.

You must click on the Save and Continue button at the top of the IQ template before you can begin entering the IQ Template Steps.
IQ Template Steps After clicking on the Save and Continue button, you can start entering steps by double-clicking in

the Step Number column

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This will open the Step Number field for input. Number the steps beginning with 1. The field will allow for decimal values (i.e. 1.1, 1.2, 1.3) if needed.

After entering the Step Number, select the Step Type. o Standard installation steps should have a step type of Install. o The Verify step type should be used for any step performed to confirm the installation. o Use the Comment step type to segment the IQ test case into specific sections depending on the needs of your IQ. o The Step Type field will determine how each step is managed during IQ execution. Enter the Step Instruction

Using the Tab key to move between fields will automatically open the next field in input mode.

To add additional steps, use the Tab key to leave the Instruction field on the current row or double click on Insert a new row Continue adding rows until all steps have been entered. Write the installation instructions providing a logical set of actions the Installer can understand. Include specific instructions to attach objective evidence during execution when required.

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To access a more detailed template step input screen, click on the Update button at the top of the IQ template screen. This will transform each step number into a link.

Click on a link to open the IQ Template Step screen for that step.

IQ Template Step Screen

The IQ Template Step screen provides a larger input area for the Step Instructions along with another text input field for Additional Details.

You can also attach a screenshot to the step that will be displayed to the installer during the IQ execution. Click the Click to add link in the Screenshot field.

Click Browse to locate the necessary image file. Click OK to attach the file.

When all information has been entered for the step, click Update to save the step and return to the IQ Template Entry screen.

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Inserting a Step If the IQ Template is in Draft or Published status, and there is more than one step, right-click on the Step Number header to reveal a context menu item to Insert IQ Step.

This will bring up a page that shows the first and last steps in the existing list, and prompts for the insertion point and the number of steps to insert. Click OK to insert the steps.

Lifecycle Dates The Lifecycle Dates tab displays system-maintained dates associated with the status of the AIQ. No input is necessary.

The Related Items field will include references to superseded versions of the IQ.

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Activity The Activity tab displays system-maintained audit trail of updates to the IQ Template. No input is necessary.

IQ Variables IQ Variables can be defined by entering a variable name in single quotes and angle brackets (i.e. <Server>) in any step instruction. The IQ Variables tab can be used to include a Default Value for each variable. Values can be entered by double-clicking in the Default Value field or be clicking on the variable name in the Name column.

During IQ execution, the installer will be prompted to enter values for any variable that have been defined. The default values will be pre-populated.

IQ Template Entry Screen Section 4

Section 4 of the IQ Template Entry Screen contains information about the approvals of the AIQ along with IQ Template Appendices.

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Approvals After a template has been submitted for approval, the Approvers tab will display the status of approvals. Templates are submitted for approval sequentially. When the author approval is entered, the template will be submitted to the next approver based on information provided in the Approval Chain section of the IQ template. See the Requesting AIQ Approval section for more information. IQ Template Appendices Multiple appendices can be added to an IQ Template. To create an appendix, click on the New button.

The IQ Template Appendix entry screen displays.

Enter a title for the appendix. Select an appendix type. Setting the Type to 'Static' will make the Information field Read-Only on the EIQ. 'Dynamic' will allow edits to the Information field in the EIQ Enter the relevant information for the appendix. Click on the Submit button to return to the IQ Template entry screen.

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To add an appendix version or delete the appendix, click on the appendix name link in the Title column. The IQ Appendix entry screen will display with additional options.

After clicking on the Add Appendix Revision button, you will be prompted for the Version and Revision Change Details. Enter the required information and click on the OK button to return to the IQ Appendix entry screen.

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Requesting AIQ Approval
To begin the approval process for an AIQ, click on the Request Approval button.

After clicking on the Request Approval button, a confirmation dialog box will be displayed. Click OK to continue or Cancel to return to the IQ Template entry screen.

Once you click OK to submit the AIQ for approval, you will be prompted to enter a document version. Enter values for: Version Revision Change Details

Click OK to continue or Cancel to return to the IQ Template Entry screen. When creating an electronic version of an existing paper-based AIQ, start with document Version 1. For reference, include the Elvis URL of the current AIQ in the Revision Change Details field.

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The Revision History section will be updated to reflect the new document version.

The Approvals section will also be updated to reflect the current status. Approvers will receive an email notification of the approval request.

Approvers can click on the Requested link to enter their approval. The approval page will be displayed with options to approve or reject the AIQ. A text field is provided for approver comments.

Clicking on the Approve (eSig) button will prompt for network id and password to complete the approval.

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Templates are submitted for approval sequentially. When the author approval is entered, the template will be submitted to the next approver based on information provided in the Approval Chain section of the IQ template. If one approver rejects the AIQ, the approval workflow will be canceled. During the approval process, the status of the AIQ will be set to Pending Approval. When all approvals have been entered, the status will be set to Published. Only then will it be available for use when creating an EIQ. When a template is in Pending Approval status, you will not be able to make any changes to the document.

Adding Document Revisions

The Add Document Revision button should be used to create an interim document version outside of the approval process. After clicking on the Add Document Revision button, the Add Revision History dialog box will be displayed. Follow the process described in the Requesting Approval section above.

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Managing Executed Installation Qualifications (EIQs)
Creating a new EIQ
Lauch Service-Now. In the left navigation panel, expand Installation Qualifications. Click on the EIQs link.

The list of existing EIQs will display. Click on the New button to start a new EIQ.

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The EIQ entry screen will be displayed.

Enter the following information: AIQ Configuration Item Environment Build Number Related task Approvers Before updating the Approval Chain, click on the Generate Steps button to populate the EIQ with the details from the AIQ template This will also set the appropriate Approval Chain based on the system category defined in the AIQ.

After clicking on Generate Steps, you will receive the following prompt:

Click OK to continue.

If there are any IQ Variables defined in the AIQ, you will be prompted to enter the appropriate values. If defaults values are provided in the AIQ, they will be displayed.

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Enter the necessary values or simply click OK to accept the defaults.

The EIQ entry screen will be updated with the details for the AIQ. Review all information provided in the EIQ before beginning the execution.

Executing an EIQ
To begin executing an EIQ, click on the link in the Step Number column of the first step.

Once the first step has been executed, the status of the EIQ will be set to Work in Progress. The Installation Procedure page is displayed.

Click on the paperclip icon to attach objective evidence when required. If an image was added to a step in the AIQ for verification purposes, it will be displayed here.

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Perform the instruction as described. If the step executes successfully, select Pass and click on the Update button. If the step does not execute successfully, select Fail click on the Update button. Then click on the step link to create an Error Log as described below. Continue until all steps are complete.

Creating an Error Log

If a step fails during execution, create an Error Log by clicking on the New button in the Error Log section of the Installation Procedure screen.

The Error Log screen will display.

Select the Error Type and Error Category. Enter the Error Description. Select the appropriate value for Retest Required. Click on the paperclip icon to attach a screenshot or any other evidence to assist in error resolution. Click Submit.

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Resolving an Error Log
The Technical Approver for the EIQ will be required to enter a resolution in order to close the error log. Lauch Service-Now. In the left navigation panel, expand Installation Qualifications. Click on the EIQ link.

Select the appropriate EIQ by clicking on the EIQ Number. Scroll to the Installation Procedures section and click on the Step Number.

The Error Log screen is displayed.

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Enter the Error Resolution. Click Update.

Requesting EIQ Approval

To begin the approval process for an AIQ, click on the Request Approval button.

After clicking on the Request Approval button, a confirmation dialog box will be displayed. Click OK to continue or Cancel to return to the IQ Template entry screen.

The Approvals section will also be updated to reflect the current status.

The approvals will follow the same process as defined in the Requesting AIQ Approval section above.

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