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

On the left sidebar, select Documents.
In the toolbar, select Upload document. The upload page opens.
Fill in the document metadata (title, description, document type).
Attach the file and select Upload Document.

Create a document from a template

On the left sidebar, select Documents.
In the toolbar, select Use Template.
In the template selector, choose a predefined template.
Complete the document form with your content.

Search for a document

On the left sidebar, select Documents.
In the toolbar search field, type a document number (for example SOP-QA-001), or 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.

Filter the register

On the left sidebar, select Documents.
In the toolbar, select Filters.
Narrow the register by Status, Type, or Owner – each is applied server-side, so a filter reflects every matching document in the tenant, not just the current page.

Active filters appear as removable chips above the register; select Clear all to reset them.

Save a filtered view

If you find yourself setting the same search text and filters every time you open the register, save them as a named view instead of rebuilding them.

On the left sidebar, select Documents.
Set the search text and filters you want to save.
Select Views in the toolbar, then select Save current view….
Enter a name and select Save.

To reapply a saved view, select Views and choose it from the list – the search text and every filter it was saved with are restored together. To remove one you no longer need, select the trash icon next to it in the list.

View a document

On the left sidebar, select Documents.
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

On the left sidebar, select Documents.
Find a document with a Draft status.
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

On the left sidebar, select Documents.
Select the checkboxes next to the documents you want to reassign.
In the toolbar, select Reassign Author.
Choose the new author and confirm.

Export the document list

On the left sidebar, select Documents.
In the toolbar, select Export.
Choose the export format and optional status filter.

Electronic signatures in the export

Every export format shows who signed each document, what they signed for, and when, as 21 CFR Part 11 §11.50 requires for the printed form of a signed record:

PDF — after the document table, a Signature Manifestation section lists each document’s current signatures, with the signer’s full name, their role, the date and time of signing (in UTC), and the meaning they recorded when they signed.
CSV and Excel — the Signed By, Signer Role(s), Signed On (UTC) and Signature Meaning(s) columns hold one entry per signature, separated by semicolons, in the same order in each column.

Only signatures that are still valid for the exported version appear. A signature that was later invalidated, for example by a rejection or a revert, is left out.

The Approvals column (Approvals Received in CSV and Excel) counts the distinct approvers whose approval signature is still valid, out of the number of approvals the document requires. It is counted from the same signatures listed alongside it, so the two never disagree: a document whose approvals were invalidated by a rejection shows 0/2, not 2/2. Other signatures, such as the release signature that makes a document effective, are listed but not counted as approvals.

Signatures, names and titles are printed exactly as recorded, including characters such as <, > and &.

In CSV files, a value that starts with =, +, - or @ is written with a single quote in front of it (for example '=SUM(A1)), so a spreadsheet shows it as text instead of running it as a formula. In Excel files the value is stored as text exactly as recorded, with no added character.

Download a signed document

When you download a PDF document that carries electronic signatures, the file you receive has a Signature Manifestation page added at the end. It lists each signature that is still valid for the version you downloaded, and names that version: the signer’s full name, their role, the date and time of signing (in UTC) and the meaning they recorded. Invalidated signatures are left out. While a new version is in draft or in review, the effective document’s download keeps listing the effective version’s signatures; the new version’s signatures appear once its file is the one being served.

The page is added to the copy you download only. The stored original is never changed, so its SHA-256 checksum, and every integrity check that uses it, stays the same. Because the downloaded copy has an extra page, its own checksum differs from the stored original’s.

The page is not added, and you receive the stored file exactly as uploaded, when adding it would damage the file or it is too large to process:

the PDF carries an embedded digital signature or fillable form fields (rebuilding the file would break the digital signature and drop the fields);
the PDF is password-protected;
the file is larger than 50 MB (administrators can change this limit with the SIGNED_COPY_MAX_BYTES setting).

The download response reports which case applied, so a system that fetches documents through the API can tell a copy with the signature page from one without it.

Page numbers on an effective document

An effective PDF — whether you download it or open it in the preview, which uses the same copy — carries on every page:

the document number (or the record id when the document has no number yet);
the version that is in controlled use;
the status Effective;
the effective date, when that version has a release date;
Page X of Y;
a CONTROLLED COPY stamp.

An SOP written in the editor gets the same line in the PDF footer, using the SOP number as the document id and the effective date recorded on the SOP when there is one. A draft or in-review SOP is numbered and named, and it is not stamped CONTROLLED COPY.

The stamp is drawn on the copy you receive. The file stored in the system is not changed, so its checksum stays the checksum of the original upload.

The stamp is not applied, and you receive the stored file, when the PDF is password-protected, carries an embedded digital signature or fillable form fields, or is larger than 50 MB. Word and Excel files download as uploaded. A training copy and an obsolete or superseded PDF keep their watermarks and are not marked as controlled copies.

Navigate between pages

Documents are displayed 25 per page with server-side pagination. When there are more documents than fit on one page, a pager appears under the table showing the range you are viewing (for example, “Showing 26–50 of 60”) — use the First / Previous / Next / Last controls to move between pages. The current page is kept in the URL, so a shared link opens on the same page.

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.

Status	Description
Draft	Document is being created and edited. Only visible to the author and users with Admin or QA roles.
Under Review	Document has been submitted for approval and is being reviewed by designated approvers.
Approved	All required signatures have been collected.
Approved - Pending Training	Document is approved but waiting for training completion to reach the configured threshold.
Effective	Document is active and in use across the organization. New versions can be created from this state.
Obsolete	Document has been retired and is no longer active. Retained for historical reference.
Superseded	Document has been replaced by a newer version or a different document.
Rejected	Document was rejected during the approval process and requires revision.
Discarded	A Draft or Rejected document was withdrawn before it ever became a controlled record. Retained in the audit trail with the discard reason; drops out of the register. See Discard a mistaken upload.

Editing document details

A document’s title and description can only be edited while it is in Draft or Rejected status. Once a document has entered the approval process (Under Review or later — even Approved, Effective, or any post-approval state), its title and description are locked; attempting to edit them returns an error explaining the record cannot be changed in its current status. To change the title, description, or content of a document that has already been approved, use a Document Change Request or upload a new version instead. The file itself can still be replaced with a new version at any status that allows it — this restriction is on the metadata fields only.

Permissions

Action	Required Role
View documents (non-draft)	All authenticated users
View draft documents	Admin, QA, QA Manager, or document owner
Upload documents	Admin, QA Team
Start approval process	Admin, QA Team
Approve documents	Users with `documents.approve` permission
Make documents effective	Users with `documents.release` permission
Configure approvals	Users with `documents.approve` permission
View versions	Users with `documents.view_versions` or `documents.approve` permission
View audit trail	Users with `audit.view_trails` or `audit.view` permission
Bulk approve	Admin, QA Team
Bulk reassign author	Admin, QA Team
Discard a draft or rejected document	Users with `documents.delete` permission (Admin by default)

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.

On the left sidebar, select Documents, then select Upload Document.
Enter the title SOP-CV-003 Cleaning Validation for Line 4, select document type SOP, and attach the PDF.
After upload, the document appears in Draft status. Open it and select Configure Approval in the toolbar.
Set Required Signatures to 3, add the QA Manager, Production Manager, and Regulatory Affairs Lead as approvers, and set the Training Threshold to 80.
Select Start Approval – the status changes to Under Review and all three approvers receive notifications.
Each approver opens the document, reviews it, and selects Approve to provide their electronic signature.
Once all three signatures are collected, training assignments go out. When 80% of assigned personnel complete training, the Make Effective button becomes available.
Select Make Effective – the SOP is now Effective and accessible to all users.
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.