Approval Workflow

The approval workflow controls how documents move from Draft through review, approval, training verification, and into effect. InnoQualis EQMS supports configurable multi-signer approval chains with electronic signatures, training threshold gates, and structured rejection discussions.

Approval states

State	Description
Not Started	Approval has not been initiated for this document.
In Progress	The approval process is active and signatures are being collected.
Completed	All required signatures have been collected.
Approved - Pending Training	Approvals are complete but the training completion threshold has not been met.
Effective	The document has been made effective and is in use.

Start the approval process

1. On the left sidebar, select Documents.
2. Select a document in Draft status to open it.
3. Select Start Approval in the toolbar.
4. The document status changes to Under Review.

Alternatively, start the approval from the Document Preview Panel:

1. On the document detail page, select the Approvals & signatures tab.
2. In the Actions card, select Start Approval Process.

Configure approval settings

Configure approval requirements before or during the approval process.

From the Approvals tab

1. On the document detail page, select the Approvals & signatures tab.
2. Scroll to the Configure Approval Settings section.
3. Set the following options:

Setting	Description	Range
Signers	Search and select users who need to sign this document.	At least 1 required
Required Signatures	Number of signatures needed to complete approval.	0 or more (cannot exceed the number of configured signers)
Threshold (%)	Percentage of signers required for approval.	1 to 100
Reminder Interval (days)	Days between automated reminders for pending signatures.	1 or more
Notify on each signature	Send notifications when each individual signature is collected.	Checkbox
Notify on completion	Send a notification when all required signatures are collected.	Checkbox

4. Select Save.

From the document detail toolbar

1. On the document detail page for a Draft document, select Configure Approval in the toolbar.
2. Set the Required Signatures count (1 to 10).
3. Set the Training Threshold percentage (0 to 100). Set to 0 if no training is required.
4. Use the Select Approvers search to find and add approvers.
5. Select Save.

Note

At least one approver must be selected before you can save the approval configuration.

Note

Required Signatures is enforced, including on workflow-governed documents. For a document governed by a workflow template that has no per-state approval rule of its own (the common case — most workflows are configured this way), the count and signer list from this dialog are the requirement: the document does not advance until that many distinct signers from the configured list have each signed, and one signature per signer counts once. Only the people on the configured list are eligible — being the document’s owner grants no seat by itself, although an owner who is nominated counts like any signer.

Note

When the workflow template ALSO defines an approval rule for the current state, both requirements apply together, not one instead of the other. The template’s rule (configured in the Workflow Templates editor — for example “at least one QA reviewer must approve”) states the organisation’s minimum for that step; the signer list and count configured here state who signs this specific record. A signer nominated here may always sign, even if they don’t hold the role the template rule names — their signature still counts toward the number required here. The template’s rule, however, is only satisfied by nominees who actually hold one of its named roles (or an Admin): a nominee without the role can complete the document-level count but does not, by itself, satisfy the template rule. The document only advances once BOTH are met, and the approval summary reports whichever “k of N” is stricter. A signer list containing no one who could ever satisfy the template’s role rule is refused when you save it, with an explanation of which role is missing.

Sign and approve a document

1. On the left sidebar, select Documents.
2. Select a document in Under Review status to open it.
3. Select Approve in the toolbar.
4. In the approval dialog, enter an Approval Reason, then under Electronic Signature select Get verification code and enter the six-digit code emailed to you. Approving a document is an electronic signature under 21 CFR Part 11 — it is not recorded until the code is confirmed.
5. Select Approve Document. The signatures count updates; when all required signatures are collected, the state advances to Completed or Approved - Pending Training.

Note

Bulk approval (approving several documents at once from a document list) is also an electronic signature — request a single verification code for the batch before confirming.

Note

If you enter an incorrect verification code, the dialog shows an inline error and re-enables the code field so you can try again — it does not sign anything, and it does not require you to close and reopen the dialog.

Alternatively, sign from the Document Preview Panel:

1. On the document detail page, select the Approvals & signatures tab.
2. Review the current approval status: Signatures (collected vs. required), Workflow State, and Training Ready.
3. Select Sign & Approve.
4. In the electronic signature modal, confirm your approval.

Make a document effective

After all approvals are collected — and, normally, once the training threshold is met — make the document effective. Release — make effective is always available once approval is complete; it is never hidden or disabled by an unmet training threshold. Making a document effective is an electronic signature under 21 CFR Part 11, same as approving one.

1. On the document detail page, select Release — make effective.
2. In the signature dialog, select Get verification code and enter the six-digit code emailed to you.
3. If the training completion threshold has not yet been met, the dialog also asks for a training waiver reason — a written justification for releasing before training completes. This is a recorded waiver, not a silent skip: it is stamped on the document (who, when, why) and appears in the audit trail. Waiving the gate can require an additional permission beyond the ordinary release permission, depending on how the document’s workflow template configures the training gate.
4. Select Confirm. The document status changes to Effective.

While a document is in the Training stage, the “What’s next” panel also shows Training threshold met and Release ready directly underneath the training progress bar — the same values the server just computed, not a recalculation. Both read “No” until the percentage of trained required users reaches the configured threshold or a waiver is recorded.

Caution

Release ready is informational only — it reflects what the server computed, but making the document effective is still gated by the separate, independent checks POST /{id}/make-effective performs at submit time (all required signatures collected, and — absent a waiver reason — the training threshold met). The two are not wired together, so treat “Release ready: Yes” as a strong signal, not a guarantee the action will succeed without a waiver reason (for example, if approvals change in the moment between viewing the panel and submitting, or the training percentage drops below the threshold in the meantime).

Reject a document

1. On the document detail page for a document in Under Review or Approved - Pending Training status, select Reject in the toolbar.
2. In the rejection modal, enter a reason for the rejection.
3. Select Reject to confirm.

Note

Who can reject follows the same eligibility rule as who can approve: if the document has a configured signer list, only the people on that list can reject it — holding the documents.approve permission alone is not enough when a specific roster is configured. Only when no signer list is configured at all does the blanket documents.approve permission decide.

Revert an approval

If something was missed during approval, an approver can return an approved document to Under Review so it can be amended and re-approved.

1. On the document detail page for a document in Approved, Approved - Pending Training, or Training status, select Revert to Review in the toolbar.
2. In the modal, enter a reason for reverting the approval. The reason is recorded in the audit trail.
3. Select Revert to Review to confirm.

The document moves back to Under Review, all current approval signatures are invalidated (the audit trail is preserved), and the document owner is notified. After the document is amended, it must go through the full signature process again.

Caution

Reverting is only available for documents that have not yet been made Effective. To withdraw an effective document, use the obsoletion workflow and issue a new version instead. Only users with the documents.approve permission (Admin, QA Team) can revert an approval. Reverting can also be disabled per template — see Per-template approval policy below.

View the signature ledger

The Approvals & signatures tab also shows the full electronic signature ledger for the document — every signature ever recorded against it, not just the current approvers list.

1. On the document detail page, select the Approvals & signatures tab.
2. Scroll below the approvers list to Electronic Signatures.
3. Each row shows who signed, when, their stated signature meaning, and a status badge:

Badge	Meaning
Valid	The signature’s stored checksum still matches — the record has not been altered since it was signed.
Invalidated	The signature was soft-invalidated (most commonly because the document was later re-signed, rejected, or the approval was reverted). Per 21 CFR Part 11, an invalidated signature is never deleted — it stays visible for the audit trail, with the invalidation reason and timestamp shown alongside it.
Integrity failed / Unverifiable	The stored checksum does not reproduce, or could not be checked. See Electronic Signatures for the full verdict states.

An invalidated signature reflects real history — for example, if an approval is reverted (see Revert an approval above), the prior signatures move from Valid to Invalidated rather than disappearing.

“Approved By” in exported SOP documents

When you export an in-app SOP document (the structured editor under SOP Documents, not a standalone uploaded file) as a PDF or Word (.docx), the Approved By field on the exported document is derived from the document’s actual electronic signatures — the same currently-valid approval signatures shown in the signature ledger above, whether recorded as an individual reviewer’s sign-off or as the final “make effective” release signature — not from any text an author or editor typed into the SOP metadata form.

• If the document has one or more currently-valid approval signatures, the export shows each signer’s name and the date/time they signed.
• If the document has never been electronically signed (or its only prior signatures were invalidated — for example, after a Revert to Review), the export shows Not Electronically Signed rather than a blank field or a stale name.
• A full Electronic Signature Manifestation section — signer, signed-at date/time, and the recorded meaning of each signature — appears in the exported file below the document control table, satisfying 21 CFR Part 11 §11.50.

The SOP metadata editor still has an Approved By text field for draft record-keeping, but it no longer appears in the exported PDF or DOCX — only a real electronic signature does.

Document templates vs. workflow templates

InnoQualis EQMS uses two related-but-distinct admin objects, both surfaced under Admin in the sidebar:

Admin tab	What it controls	Example
Document Templates	The starting file an author downloads when creating a new document — a Word .docx (or .pdf) blueprint with structured sections.	“SOP-Template-v2.docx” with pre-filled Purpose / Scope / Procedure sections.
Workflow Templates	The approval lifecycle the document moves through — states, transitions, approval rules, and post-approval policy.	“Standard SOP Workflow” with states draft → review → approved → training → effective and a QA Manager required at review.

A real document ends up with both: it is created from a Document Template (the file shape) and governed by a Workflow Template (the approval process). They are configured independently — any file template can be paired with any workflow.

Per-workflow approval policy

Admins can lock down post-approval actions per workflow template. This is useful for highly regulated workflows (for example a clinical-protocol master) where rolling an approval back must go through a stricter alternative process.

Each workflow template exposes two toggles, both on by default so existing workflows retain current behavior:

Toggle	When off
Allow revert approval	The Revert to Review button is hidden on documents using this workflow, and the API rejects revert requests with 403.
Allow reject after approval	The Reject button is hidden once the document reaches a post-approval state, and post-approval rejection requests are rejected with 403.

To configure:

1. On the left sidebar, select Admin → Workflow Templates.
2. Open the workflow you want to change (Edit, or Create a new one).
3. In the Approval policy section of the modal, toggle the checkboxes.
4. Save. Changes apply live to all documents governed by that workflow — including documents that were already mid-flight.

Note

Only Admin users can change workflow policy. The flags are read on every action; turning a toggle off blocks the action immediately, no document re-issue required.

State capability flags

Workflow states can be named anything (in any language), but the document lifecycle still has standard phases that the rest of the system needs to understand: drafting, review, post-approval, training, effective, periodic review, archived. Each workflow state declares which phase(s) it represents via capability flags. The flags drive every UI button and every backend gate — so a state named “Senior Quality Lead Review” works exactly like one named “under_review”, as long as it has is_review ticked.

Flag	Meaning	Unlocks
Initial	The state a new document starts in.	Document creation.
Terminal	No outbound transitions; lifecycle is finished.	(closes the workflow)
Allows edit	The author can edit document content.	Edit button on the document detail page.
Allows new version	The author can branch a new version.	New Version button.
Requires approval	Approve / reject signatures are required to leave the state.	Approve, Reject buttons.
Draft	Authoring pre-approval phase.	Start Approval button, edits, version creation.
Review	Approval-collection phase.	Approve, Reject buttons (mirrors Requires approval but is read by frontend gates).
Post-approval	Approved but not yet effective.	Revert to Review, post-approval Reject.
Training	Training-stage holding pen.	Auto-assign training, Make Effective via training-threshold check.
Effective	Live and in use.	Mark Obsolete, New Version, supersession.
Periodic review	Scheduled re-evaluation; document remains effective but is flagged.	Periodic review queues.
Archived	Lifecycle ended (obsolete, superseded, withdrawn).	Suppress from default lists / dashboards.

Flags are not mutually exclusive — a training state typically has both is_post_approval and is_training ticked. The editor’s Validation panel flags conflicting combinations (e.g. is_draft && is_effective) and required ones (e.g. requires_approval with no matching approval rule).

How the Revert button decides when to appear

The detail page reads capabilities.can_revert_approval from the document response. That flag is true when:

1. The current workflow state has is_post_approval = true, and
2. The document’s workflow template’s allow_revert_approval policy is true (the per-workflow toggle from the previous section).

Both conditions are evaluated live on every page load — no schema migration is needed when an admin re-tags a state. The custom-state-name workflow case works the same way: tick is_post_approval on the relevant custom state and the Revert button appears.

Workflow design canvas (desktop)

On desktop, the Workflow Templates create/edit modal opens to a full-screen canvas where the workflow is built directly:

• States are draggable cards — color-coded by capability (green for effective, blue for post-approval, orange for training, etc.). Drag them around to lay out the diagram however you like.
• Click a state to edit it — the side panel on the right opens with the full state form: internal name, display name, description, color, lifecycle phase checkboxes, and (when the state requires approval) the approval rules for that state.
• Drag from one state’s right edge to another’s left edge to create a transition. The transition’s edit panel opens automatically so you can name it.
• Click an existing transition (the arrow) to edit it.
• Hover a state and click the trash icon to delete it.
• Add State button sits in the top-left corner of the canvas; the empty state offers an Add First State CTA.

The validation panel below the canvas surfaces structural issues live (no initial state, conflicting flag combinations, transitions referencing missing states, etc.) and disables Save when there are errors.

Mobile fallback

On screens narrower than 1024 px the canvas is too cramped for direct manipulation. Mobile keeps the previous list-of-cards layout: a read-only mini-diagram followed by separate States, Transitions, and Approval Rules sections you scroll through and edit individually.

Document templates: file formats

The Document Templates admin tab accepts Word documents (.doc, .docx) and PDFs (.pdf). PDFs are useful for read-only blueprints (regulatory references, fixed boilerplate) where authors should not be able to alter the master.

Note

Approve and Reject actions live on the document detail page only. The Documents listing no longer offers per-row Approve/Reject buttons — open the document to take action so the reason prompt and audit trail are always captured.

Respond to a rejection

When a document is rejected, a Rejection Discussion panel appears with a threaded conversation.

Message Type	Color	Description
Rejection	Red	The initial rejection with reason and comments
Response	Blue	Responses from the document owner or other participants
Escalation	Orange	Requests to escalate the discussion to management
Resolution	Green	Final resolution marking the discussion as closed

1. In the Rejection Discussion panel, type your response in the Add Response text area.
2. Select Send Message.

Escalate a rejection

If you cannot resolve the rejection through discussion:

1. Below the discussion thread, select Escalate to Management.
2. In the dialog, enter the reason for escalation.
3. Select Escalate.
4. The escalation appears as an orange-highlighted message in the thread.

Resolve a rejection

Once the rejection issues have been addressed:

1. Below the discussion thread, select Mark as Resolved.
2. Enter the resolution details describing how the rejection was addressed.
3. Select Mark Resolved.
4. The discussion thread becomes read-only with a “Resolved” badge.

Approve multiple documents at once

1. On the left sidebar, select Documents.
2. Select the checkboxes next to the documents you want to approve.
3. Select the bulk approve action in the toolbar.
4. The signing dialog opens once it has loaded the full list of documents from the server — every document’s number and title is shown before the confirmation code field appears.
5. If your batch has more than 10 documents, you must first type the exact document count into a confirmation field before the confirmation code field becomes usable. This is a deliberate extra step: it forces you to actually register how many records you are about to sign, rather than clicking through a large batch on autopilot.
6. Request and enter your confirmation code, then select Sign & approve documents.

Tip

Bulk approval is only available for users with the Admin or QA Team role. The bulk action button appears when one or more documents are selected.

Note

You can sign up to 500 documents in a single batch — one confirmation code covers the whole batch, matching how a single continuous, re-authenticated signing session is permitted under 21 CFR Part 11 §11.200(a)(1)(i). What changes above 10 documents is not the cap, but the extra typed-count confirmation step: each signature this action creates records which batch it belonged to and how large that batch was, so an auditor reviewing the signature history can see it was signed deliberately as part of a reviewed group, not as an isolated click. A single-document approval (outside this bulk action) never carries batch information.

Practical example: approving a batch record template

Scenario: A new batch record template (BR-101) for tablet manufacturing needs approval from three department heads before production can use it.

1. The QA Specialist uploads BR-101 and opens the document detail page.
2. On the Approvals & signatures tab, under Configure Approval Settings, they add three signers: the QA Manager, the Production Director, and the Validation Lead.
3. They set Required Signatures to 3, Threshold to 100, and Reminder Interval to 3 days.
4. They check both Notify on each signature and Notify on completion, then select Save.
5. They select Start Approval Process — all three approvers receive an email notification.
6. The QA Manager opens the document, reviews it, selects Sign & Approve, and confirms with their electronic signature.
7. The Production Director does the same the next day. The Validation Lead is traveling and receives an automated reminder after 3 days.
8. After the Validation Lead signs, all signatures are collected and the training threshold shows “Ready” (no training was required for this template).
9. The QA Specialist selects Make Effective to make BR-101 available for production use.

If the document is rejected: The Production Director selects Reject and enters “Section 4.2 missing hold time specification.” The QA Specialist sees the rejection discussion, responds with a revised section, and selects Mark as Resolved once the issue is addressed. The approval process restarts.

Permissions

Action	Required Role / Permission
Start approval process	Admin, QA Team
Configure approval settings	documents.approve permission
Sign and approve	documents.approve permission
Make document effective	documents.release permission
Reject document	Admin, QA Team
Revert approval (Approved → Under Review)	Admin, QA Team (documents.approve); subject to workflow policy
Configure workflow approval policy	Admin
Manage document templates (file blueprints)	Admin (Word/PDF uploads, version history, approval lifecycle)
Bulk approve	Admin, QA Team
View the signature ledger	Admin, QA Team, Auditor (any resource), the document’s owner, or anyone holding documents.approve/documents.update on it — someone who can act on the approval can also see who has already signed