Approval Workflows

Approval Workflows define the multi-step approval process that entities (documents, audits, CAPAs, complaints, MRMs, etc.) must go through before they can be finalized. Each workflow consists of one or more approval steps, where each step is assigned to a Role.

Overview

An approval workflow specifies:

• Name — A descriptive name (e.g., "Document Approval", "CAPA Closure Approval")
• Description — An optional explanation of when this workflow should be used
• Entity Type — The type of entity this workflow applies to (e.g., Document, Audit, CAPA, Complaint, MRM)
• Steps — One or more sequential approval steps, each assigned to a role

Supported Entity Types

Approval workflows can be created for the following entity types:

Approval Types

Each step in a workflow can use one of the following approval types:

• Role — Any user assigned to the specified role can approve
• User — A specific user must approve

Execution Types

Steps can be executed in different ways:

• Sequential — Steps are executed one after another in order
• Parallel — Multiple steps can be executed simultaneously

Viewing All Workflows

1. Navigate to QMS → Approval Workflows from the sidebar
2. You will see a table listing all existing workflows with:
   • Workflow Name
   • Entity Type — Which type of entity this workflow applies to
   • Number of Steps
   • Description
   • Actions (Edit, Delete)

Creating a New Workflow

1. Navigate to QMS → Approval Workflows
2. Click the Create Workflow button in the top-right corner
3. Fill in the workflow details:
   • Name (required) — Enter a name for the workflow (e.g., "CAPA Two-Step Approval")
   • Description — Optionally describe when this workflow should be used
   • Entity Type (required) — Select the type of entity this workflow applies to
4. Add approval steps:
   • Each step requires:
     • Step Name — A descriptive name (e.g., "Quality Head Review")
     • Step Order — The order in which the step is executed (auto-assigned)
     • Approval Type — Select "Role" or "User"
     • Role — If approval type is "Role", select the role whose members can approve
     • Approval Count — Number of approvals required from the role (default: 1)
     • Execution Type — Sequential or Parallel
   • Click the Add Step button to add more steps
   • Use the up/down arrows to reorder steps
   • Click the remove button to delete a step
5. Click Save to create the workflow

Example: Two-Step Document Approval

In this example, the document first goes to the Quality Assurance role for review, and then to the Managing Director role for final approval.

Editing a Workflow

1. Navigate to QMS → Approval Workflows
2. Find the workflow you want to edit
3. Click the Edit button (pencil icon) in the Actions column
4. Modify the workflow name, description, entity type, or steps
5. Click Save to update the workflow

Deleting a Workflow

1. Navigate to QMS → Approval Workflows
2. Find the workflow you want to delete
3. Click the Delete button (trash icon)
4. Confirm the deletion in the popup

Warning: Deleting a workflow that is referenced by active approval instances will not affect those in-progress approvals, but you will no longer be able to start new approvals with this workflow.

How Approvals Work

When an entity (e.g., a CAPA or an audit report) is submitted for approval:

1. The user selects which approval workflow to use
2. The system creates an Approval Instance and starts the first step
3. Users assigned to the role in the current step receive a notification under Pending Approvals
4. An approver can either Approve or Reject with comments
5. If approved, the workflow advances to the next step (if any)
6. If rejected, the entity is sent back and its status changes to "Rejected"
7. Once all steps are approved, the entity's status changes to "Approved"

Approval Statuses

Pending Approvals

Users can view their pending approvals by navigating to QMS → Pending Approvals. This page shows all approval instances where the current user is an eligible approver for the active step.

From this page, approvers can:

• View the entity details
• Approve with optional comments
• Reject with required comments

Best Practices

• Keep workflows simple — 2–3 steps is usually sufficient for most processes
• Match workflows to your SOP — Your approval workflows should reflect your documented standard operating procedures
• Use descriptive names — Name workflows clearly so users know which one to select (e.g., "SOP Approval - 2 Level" vs "CAPA Closure - QA + MD")
• Create separate workflows per entity type — Even if the approval steps are similar, having separate workflows for Documents, CAPAs, and Audits makes it easier to manage

Next Steps

• Make sure you have Roles set up before creating workflows
• Learn how approval workflows are used in Internal Audit, CAPA, Complaints, and MRM