CR: Change Requests

Change Requests are part of the AODocs for Life Sciences Create package, which lets you manage document control, change management and training processes. Learn more about the AODocs for Life Sciences packages.

All Create processes are included in the AODocs for Life Sciences Grow package, which lets you to manage CAPAs, Quality Events and Audits. Use the Grow package to enrich and expand your quality management system with automated workflows and processes.

A Change Request (CR) is a document containing a proposal for an adjustment to an existing control Document. A CR can also contain a proposal to create a new control Document. CRs allow you to update multiple control Documents using the same approval process.

This article describes how to create Change Requests. You can also find information about the CR workflow and CR properties.

How do CRs integrate with other AODocs for Life Sciences processes?
Create CRs
          Create CRs from CAPAs
          New CR
          Draft
          Cancelled
          DC review
          Rejected from DC review
          In-approval
          Rejected from In-Approval
           Approved
          Closed
The CR workflow
CR properties

How do CRs integrate with other AODocs for Life Sciences processes?

CRs are usually initiated as a standalone process with related Control Documents.

You can also initiate a CR from a CAPA, during the Implementation review workflow transition. The related Control Documents can be sent to appropriate members of your organization to be read and acknowledged. In addition, they can be related to Training documents. Learn more: Closed.


Create CRs

Create CRs from CAPAs

When you create a CR from a CAPA, it’s usually because you want to make a formal recommendation to update one or more existing Documents. These are usually effective documents, which means that they have been approved and published. Add the Documents you want to update as related Documents in your CAPA. When your CR is generated from your CAPA, the related Documents are added as related Documents in your CR. In addition, draft versions of your related Documents are created so you can update them while the published versions remain visible to users. The CR workflow allows you to update the draft, approve it, and validate the new version as an effective document.

Note: If you want to use your CR to create one or more new Documents (rather than to update existing Documents), create your CR from your CAPA without any related Documents, then create new related Documents from the CR.

Below is a summary of how to create a CR from a CAPA.

1. In your CAPA:

  • activate the switch Create CR on implementation approval in your CAPA before or during the Implementation review workflow state
  • optionally, add one or more effective Documents as related items in your CAPA

Notes:
– You can’t create new Documents as related items because you can only relate effective documents to your CAPA.
– If required, in your Document, activate the Training required? switch and enter one or more people in the Trainees property. Learn more: Closed.

2. As a reviewer, accept the Implementation review of your CAPA: press the workflow button and select Accept. These changes are made:

  • Your CAPA transitions to the Pending Change request workflow state.
  • A related Change Request is automatically created in your CAPA.
  • Any Documents you added as a related item in your CAPA become related to the Change Request (New CR workflow state). They become drafts so you can update them. Learn more from AODocs: View the draft version of a document.

Below is a description of how to create a CR. Each section corresponds to a different state in the workflow, corresponding to the lifecycle of a CR. Learn more: The CR Workflow.

Some properties are mandatory when you first create your CR. Other properties are optional throughout the workflow. You can fill in optional properties at any point. You can consult the full list of CR properties.

New CR

1. As a member of the Collaborators role, either:

image01.pngCAPA with a related CR and two related draft Documents

Important: Make sure the correct permissions are defined in your draft Documents. Anyone who doesn’t have permissions to view or edit the drafts can only see the main version of the Documents. Learn more from AODocs: View the draft version of a document and View the main version of a document.

If you generated your CR from a CAPA, the following properties are filled in automatically:

  • CR #
  • CR Title: generated from the CR # and the title of the CAPA
  • Created from: populated with a link to the related CAPA
  • Document Owner: populated with the name of the person who approved the implementation plan in your CAPA

Note: If you created a standalone CR, you must fill in these properties manually (except CR #, which is filled in automatically when you save your CR).

image02.png

2. Fill in the remaining mandatory properties:

  • Description of Change
  • Approvers

Learn more from AODocs: Edit custom properties.

3. Save your document.

Draft

When you save your CR, it transitions to the Draft workflow state.

During the Draft workflow state, you can create new related Documents or add existing related Documents that require changes.

Notes:
– When you add related Documents, only Documents in the New or Draft workflow states that are not already related to another Change Request are displayed for selection. A Document can be related to only one Change Request. However, a Change Request can have multiple related Documents.
– Your CR must contain at least one related Document. If required, it can contain a mixture of existing Documents to update and newly created Documents.
– If required, in your Document, activate the Training required? switch and enter one or more people in the Trainees property. Learn more: Closed.

Update (or create) and review your related Documents:

  • Any related Documents that were previously Effective (that is, validated and published, and need to be updated) transition through these workflow states:
      • Draft - Collaboration
      • Draft - In-Review
      • Draft - Reviewed
  • Any newly created related Documents transition through these workflow states:
      • Collaboration
      • In-Review
      • Reviewed

Note: You can’t transition your CR from the Draft workflow state if:
– any related Documents haven’t yet been transitioned to the Reviewed or Draft– Reviewed state
– there are no related Documents in your CR

1. As a document owner, in your CR, press Draft and select Send to DC review to transition the CR to Document Control (DC) review and switch its related Documents to the Pending Change Request state.

Note: As a member of the DC team, the Cancel option is available to transition the CR to the Cancelled workflow state. If you select Cancel, you must leave a comment in the Perform Workflow Action pop-up.

2. If required, leave a comment in the Perform Workflow action pop-up. Then press Submit.
The workflow transitions to the DC review state.

Learn more from AODocs: Perform workflow actions in a document.

image03.png

Cancelled

Your CR is in the Cancelled workflow state if you select Cancel in the Draft, DC review, In-approval or Approved workflow state.

Note: CRs can be cancelled by a member of the DC team in the Draft, DC review or Approved workflow states, or by an Approver in the In-approval workflow state.

When the CR is cancelled, the Documents you added or created as related items are no longer related. The previously related Documents are listed in the Related documents property in your CR, with links. This maintains the history of the CR and its related Documents.

Learn more:

Important: When a CR has been cancelled, there are no workflow actions available to return it to an active workflow state. However, library administrators can force the CR to a different workflow state if required. Learn more from AODocs: Force workflow actions.

DC review

Your CR is now in the Document Control (DC) Review workflow state. Learn more: The CR workflow.

When your CR transitions to this workflow state, its related Documents change to the Draft - Pending change request or Pending change request state.

The purpose of the DC review is for a member of the DC team to check and confirm that everything is ready for approval.

1. As a member of the DC team, press DC Review and select an option from the drop-down menu:

  • Approve to transition the CR to the In-approval workflow state
  • Reject to transition the CR back to the Draft workflow state
  • Cancel to transition the CR to Cancelled

Note: If you select Reject or Cancel, you must leave a comment in the Perform Workflow Action pop-up.

2. If required, leave a comment in the Perform Workflow action pop-up. Then press Submit.
The workflow transitions to the In-approval workflow state.

image04.png

Rejected from DC review

This workflow state exists to record the fact that the CR was rejected from DC review, for the purposes of reporting. When a member of the DC team selects Cancel in the DC review workflow state, the CR passes through the Rejected from DC review state and then transitions directly to the Draft workflow state.

In-approval

Your CR is now in the In-approval workflow state. Learn more: CR workflow.

As an approver, open the custom actions menu and select an option:

  • Approve the CR: to approve the CR and transition the CR to the Approved workflow state.
  • Reject the CR: to reject the CR and transition the CR to the DC review workflow state
  • Cancel the CR: to transition the CR to the Cancelled workflow state

A new tab opens where you must perform two-factor authentication via DUO.

Note: If you select Reject the CR or Cancel the CR, you must enter a comment before performing two-factor authentication.

Note: If there’s more than one approver defined, the CR:
– transitions to Approved only when all approvers have approved the CR via DUO
– transitions to the DC review workflow state or Cancelled as soon as one approver rejects or cancels the CR via DUO

image05.png

Rejected from In-Approval

This workflow state exists to record the fact that the CR was rejected from In-approval, for the purposes of reporting. When a member of the DC team selects Cancel in the In-approval workflow state, the CR passes through the Rejected from In-approval state and then transitions directly to the DC review workflow state.

Approved

Your CR is now in the Approved workflow state. Learn more: The CR workflow.

As a member of the DC team, press Approved and and select an option:

  • Close: to transition the CR to the Closed workflow state
  • Cancel: to transition the CR to the Cancelled workflow state

image06.png

Closed

Your CR is now in the Closed workflow state. The workflow for your CR is complete. The related Documents in your CR change to the Effective workflow state and are no longer in draft.

When you transition your CR to Closed, the Documents you added or created as related items:

  • switch to one of these workflow states:
      • Effective if no training is required
      • Effective pending training if the Training required? switch is active in the Document – in this case, a Training document is created automatically and you must add one or more names in the Trainees property in your Document
  • are no longer related to your CR; the previously related Documents are listed in the Related documents property in your CR, with links. This maintains the history of the CR and its related Documents.

image07.png


The CR workflow

The workflow below shows the states involved in creating a CAPA.
Learn more about the properties that need to be filled in at each state.

CRworkflow.png


CR properties

Below is a list of the properties available throughout the process of creating a CR.

Section Property Description Mandatory at which state in the CAPA workflow?
Top level of list of properties CR #

Incremental reference number that is automatically generated and filled in. It’s used to populate the title of your CR (along with the value of CR Title) when you save it.

Note: If you change its value, it is overwritten with the automatically generated value

New CR
  CR Title

Populates the title of your CR when you save it (along with the value of CR #).

If you initiated a CR from a CAPA, the CR Title property is automatically filled in with CR for [CAPA title].

Otherwise, fill in a value manually.

New CR
  Document Owner

Owner of the process.

You can define one or more people.

Filled in automatically with the email of the person who created the CR.

If you enter a different name during the CR creation phase, it is replaced with your name (assuming you’re a member of the Collaborator’s group) when you save the CR. However, you can choose a different name or add other names once the CR has been created.

N/A

  Created from Filled in automatically with a link to the related CAPA if you initiated your CR from a CAPA. N/A
Description Description of Change Manually enter a description of the change required. New CR
  Justification Manually enter a justification of the change. Always optional
  Assessment Text field to capture analysis of the CR. Always optional
  Related Documents When your CR transitions to the Closed or Cancelled workflow state, the Documents you added or created as related items are no longer related. They are listed in Related Documents property with links N/A
Approvals Approvers

The names of the people who transition the CR from the In-approval workflow state to Approved (or to DC review or Cancelled).

You can define one or more approvers.

New CR
  Pending Approvers

Filled in automatically during the transition from Draft to DC review.

Note: If you add approvers once the CR has transitioned to DC review, they aren’t transferred to the Pending approvers property and can’t transition the CR from the In-approval state.

N/A
  Completed Approvals Filled in automatically with the name of approvers and a timestamp when approvers transition the CR from In-approval to Approved. N/A
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