Approval Workflow for Lanes and SOPs

1. How to add and start the Approval Workflow to a Lane or SOP?
2. Add External Approvers
3. User Roles in the Approval Workflow
4. Stages within the Approval Workflow
5. Restarting the workflow for approved Lanes or SOPs

To replace manual processes to sign and document Lane SOPs and Lane Risk Assessment, Validaide offers the option for digital collaboration with Approval Workflow and digital signatures.  These approvals can be added by users within your company, but also jointly with approvers at external companies. For SOPs, we also offer the option for joint editing with "external contributors", so multiple companies can jointly create an SOP.

The Approval Workflow functionality is automatically enabled for the Lane or SOP. Lanes and SOPs with 'Approval Workflow' provide a complete version history, so you have a complete overview of previous approvals.

If you want to add external approvers, you must first share the Lane or SOP with the involved party.

You can read more about this here: More on sharing a lane.

Lane and SOP bulk actions.

How to add and start the Approval Workflow to a Lane or SOP?

Click on the 'Start Workflow' button. The user must add a Revision Period, which must be a numeric value in months with a default value of 12 months. (Min 6, max 24 Months). After starting the workflow the status of the lane/SOP is changed to "In Progress".

Clicking on Start Workflow will add another tab Version Control will be added to the page of a Lane or SOP. In this tab, the complete version control of the approval process is documented accordingly.

After starting the Approval Workflow and assigning the involved users. In a pop-up window, the user is asked to define the review period for that Lane or SOP, the Responsible User for this Lane and the Approver(s) within your company.

Up to 6 users can be assigned the Approver and the QA roles, and everyone will be notified accordingly.

When approving a lane or SOP your email and password must be entered to approve with a digital signature. 

Companies can choose if they want to enable or disable sign-off with email and password. A toggle "Require email and password when signing electronic records" is in the Tenant Administration Configuration Settings under the Workflow tab.

Add External Approvers

In order to involve external approvers in your approval workflow (have your customer approve a lane or SOP with a digital signature) you first have to share the lane or SOP. After you have shared the lane or SOP another window will appear in the pop-up window.

You can later add or change involved users for unapproved lanes or SOPs by going to the "Version Control" tab by clicking on the pencil icon or in the "Configuration" tab under "User Roles".

Only users involved in the approval workflow or with admin access can add, remove, or change involved users in an Approved lane or SOP. Users with contributor access can edit user roles when lanes/SOPs are in any other statuses, when a lane/SOP is approved they cannot.

User Roles in the Approval Workflow

In the approval workflow, the following roles are defined, which can be assigned to Editors and Administrators:

To edit a Lane or SOP:

• Responsible User (for Lanes and SOPs): This person is responsible for configuring the Lane or SOP and then submitting it for review.
• Internal Contributors (for SOPs): These users can edit the SOP Configuration, along with Contact, Process, and Files sections. These users cannot submit the SOP for review.
• External Contributors (for SOPs): To enable the joint creation of SOPs, Validaide provides this optional role for users of external companies that can edit the Contact and Process section of a shared SOP (when it is in the 'In Progress' state). These users cannot submit the SOP for review.
• Internal Contributors (for Lanes): These users can edit lane configuration and modify lane steps, but they cannot submit the Lane for review.
• External Contributors (for Lanes): These users can modify their user roles, update packaging information, and edit lane performance, but they cannot modify lane steps. Please note that this applies only to Pharma Manufacturer companies on the Premium plan.

 To approve a Lane or SOP

• Internal Approvers: These persons are users of the Owner of the Lane or SOP with the responsibility to approve the Lane or SOP. 
• Internal QA: This is an optional role at the lane owner's company. These users also must approve the Lane or SOP. You can assign up to 6 Internal QA users.
• Internal Contributors: This is an optional role at the lane owner's company. These users cannot approve or reject a lane.
• External Approvers: This is an optional role for users of external companies that also must approve the Lane or SOP. You can assign up to 6 External Approvers after you have shared the Lane or SOP with the external company, which must be a Party on the Lane or SOP (e.g. as Forwarder, Primary Carrier or Customer). 
• External QA: This is an optional role for users of external companies that also must approve the Lane or SOP. You can assign up to 6 External QA users after you have shared the Lane or SOP with the external company, which must be a Party on the Lane or SOP.
• External Contributors: This is an optional role for users of external companies. These users cannot approve or reject a lane.

Note: Administrators are users with special access rights, and therefore can edit, submit, and approve Lanes or SOPS without being assigned to any of these roles.

User Types and Their Access Rights

Changing these User Roles can be done in the User Roles form in the Lane or SOP Configuration Tab:

Stages within the Approval Workflow

The Approval Workflow for Lanes and SOPs contains the following steps:

In Progress	After the approval workflow for the Lane or SOP has started, the Responsible User will configure the Lane or SOP. When completed, the Responsible User submits the Lane or SOP for review by the Approvers.
Internal Review	During Internal Review it is no longer possible to change the configuration of the Lane or SOP as the Internal Approvers must approve the Lane or SOP. Approval is granted by reconfirming your password to provide a digital signature. When this is completed by all Approvers, the Lane or SOP is set to Approved, or in case of external Approvers to External Review.
Internal QA Review	During Internal QA Review it is no longer possible to change the configuration of the Lane or SOP as the Internal QA Approvers must approve the Lane or SOP. Approval is granted by reconfirming your password to provide a digital signature. When this is completed by all QA Approvers, the Lane or SOP is set to Approved, or in case of external Approvers to External Review.
External Review	In case also external Approvers are assigned, the external Approvers must approve the Lane or SOP after the internal Approvers.
External QA Review	In case also external QA Approvers are assigned, the external QA Approvers must approve the Lane or SOP after the external Approvers.
Approved	Only once all Approvers have approved the Lane or SOP, will the status switch to Approved.  Once a Lane or SOP is approved, the details of that Lane cannot be modified anymore as everything is locked.
About to Expire	One month before the revision date of the Lane or SOP is reached, the status will be automatically changed to About to Expire and relevant users will be notified. This allows the users to review if any updates must be made to the Lane or SOP.
Expired	When the revision period has expired, the Lane or SOP is automatically set to Expired. In this case, the Responsible User must review the Lane or SOP, and re-submit this for review.

Notes:

• Notifications and Tasks: Validaide will send out e-mail notifications to the involved users for all changes in workflow stages. Furthermore, users will have a task assigned for the actions they need to perform, such as the approval of a Lane or SOP. 

• Rejecting a Lane: Approvers also have the option to reject the lane. In this case, they need to give a reason for rejection in the form of a comment which will be visible in the Version Control. If the lane is rejected, the workflow starts again and the status is set back to In Progress.

• When approving the lane or SOP a pop-up screen appears with a message:” Be aware that you are now signing an electronic record which is equivalent to a hand-written signature”, to notify of the use of a digital signature. When approving a lane or SOP your email and password must be entered to approve with a digital signature. 

  

• Filtering on Workflow stage: both the Lane and SOP listing screen allow you to filter Lanes and SOPs on the workflow stage.

Restarting the workflow for approved Lanes or SOPs

If underlying information changes in a Lane (i.e. an air carrier updates its supplier capabilities), this will be indicated accordingly. What has changed can be reviewed by clicking on Show Differences.

In case you wish to update your Lane or SOP with new information, you can do so by clicking on Restart Workflow at the top right of the screen. This will change the status of the Lane or SOP back to In Progress. Workflow can be restarted by the responsible person or user with admin rights.

Note: When restarting the workflow of a lane or SOP your email and password must be entered to approve with a digital signature.

 

See videos: