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InnoQualis InnoQualis Docs

Document Control

Document Control is the central module for managing all quality management system documents in InnoQualis EQMS. It provides a structured, GxP-compliant workflow for creating, reviewing, approving, making effective, and retiring documents such as SOPs, policies, work instructions, and specifications.

Upload a document

Section titled “Upload a document”
  1. On the left sidebar, select Documents.
  2. In the toolbar, select Upload Document.
  3. Fill in the document metadata (title, description, document type).
  4. Attach the file and select Upload.

Create a document from a template

Section titled “Create a document from a template”
  1. On the left sidebar, select Documents.
  2. In the toolbar, select Use Template.
  3. In the template selector, choose a predefined template.
  4. Complete the document form with your content.

Search for a document

Section titled “Search for a document”
  1. On the left sidebar, select Documents.
  2. In the toolbar search field, type a title or description keyword. Results update automatically as you type.

The search query is preserved in the URL, so you can bookmark or share filtered views.

View a document

Section titled “View a document”
  1. On the left sidebar, select Documents.
  2. Find the document in the table and select View in the Actions column.

The document detail page shows the full metadata, file preview, version history, and audit trail.

Start the approval process

Section titled “Start the approval process”
  1. On the left sidebar, select Documents.
  2. Find a document with a Draft status.
  3. Select Approve in the Actions column for that document.

The document status changes to Under Review and designated approvers are notified.

Reassign document ownership in bulk

Section titled “Reassign document ownership in bulk”
  1. On the left sidebar, select Documents.
  2. Select the checkboxes next to the documents you want to reassign.
  3. In the toolbar, select Reassign Author.
  4. Choose the new author and confirm.

Export the document list

Section titled “Export the document list”
  1. On the left sidebar, select Documents.
  2. In the toolbar, select Export.
  3. Choose the export format and optional status filter.
Section titled “Navigate between pages”

Documents are displayed 10 per page with server-side pagination. At the bottom of the table, select Previous or Next to move between pages.

Document lifecycle

Section titled “Document lifecycle”

Every document follows a defined lifecycle represented by its status. The workflow progress indicator on the document detail page shows the current stage visually.

StatusDescription
DraftDocument is being created and edited. Only visible to the author and users with Admin or QA roles.
Under ReviewDocument has been submitted for approval and is being reviewed by designated approvers.
ApprovedAll required signatures have been collected.
Approved - Pending TrainingDocument is approved but waiting for training completion to reach the configured threshold.
EffectiveDocument is active and in use across the organization. New versions can be created from this state.
ObsoleteDocument has been retired and is no longer active. Retained for historical reference.
SupersededDocument has been replaced by a newer version or a different document.
RejectedDocument was rejected during the approval process and requires revision.

Permissions

Section titled “Permissions”
ActionRequired Role
View documents (non-draft)All authenticated users
View draft documentsAdmin, QA, QA Manager, or document owner
Upload documentsAdmin, QA Team
Start approval processAdmin, QA Team
Approve documentsUsers with documents.approve permission
Make documents effectiveUsers with documents.release permission
Configure approvalsUsers with documents.approve permission
View versionsUsers with documents.view_versions or documents.approve permission
View audit trailUsers with audit.view_trails or audit.view permission
Bulk approveAdmin, QA Team
Bulk reassign authorAdmin, QA Team

Practical example: managing a new SOP through its lifecycle

Section titled “Practical example: managing a new SOP through its lifecycle”

Scenario: Your QA team has drafted a new cleaning validation SOP (SOP-CV-003) for a medical device production line.

  1. On the left sidebar, select Documents, then select Upload Document.
  2. Enter the title SOP-CV-003 Cleaning Validation for Line 4, select document type SOP, and attach the PDF.
  3. After upload, the document appears in Draft status. Open it and select Configure Approval in the toolbar.
  4. Set Required Signatures to 3, add the QA Manager, Production Manager, and Regulatory Affairs Lead as approvers, and set the Training Threshold to 80.
  5. Select Start Approval — the status changes to Under Review and all three approvers receive notifications.
  6. Each approver opens the document, reviews it, and selects Approve to provide their electronic signature.
  7. Once all three signatures are collected, training assignments go out. When 80% of assigned personnel complete training, the Make Effective button becomes available.
  8. Select Make Effective — the SOP is now Effective and accessible to all users.
  9. Six months later, a process change requires an update. A team member opens the document and selects Request Change to submit a formal DCR describing the modification.
Section titled “Related pages”