Introduction 

Documents are everywhere!
Every team, every department, every person relies on them. From engineering to quality, procurement to marketing, documents are at the core of how work gets done. And even in our digital, automated, process-driven world, they haven’t gone away. They’re still at the heart of how we work, collaborate, and make decisions.

But not all documents are created or managed equally:
Some are informal, created for a quick reference or internal discussion, and can be created, updated, shared, or replaced with minimal oversight.

Controlled documents, however, are those that contain formal records that define processes, procedures and standards. They are commonly used in industries where compliance with regulations, standards, or internal policies is critical, such as in pharmaceuticals, aerospace, manufacturing, and healthcare sectors. 
Examples are: standard operating procedures (SOPs), quality manuals, safety protocols, and technical specifications.

Because they drive essential operations and ensure compliance, controlled documents must follow a clearly defined Document Control process.

A Document Control Process is a structured, systematic approach used to manage critical business documents, especially those related to compliance, quality, and safety.

This process governs the entire document lifecycle - from initial creation, through review and approval, all the way to distribution and eventual retirement.
It ensures that the right people have access to the right version of the right document at the right time.

In this blog, we’ll explore the essential elements of an effective Document Control process and show how ENOVIA 'Quality Document Author' role helps organizations streamline, standardize, and strengthen every step along the way.
 

ENOVIA Solution for Document Control Process

ENOVIA offers the 'Quality Document Author (QUC)' role: an enterprise-wide, collaborative solution designed for managing controlled documents.
In 2024X GA release, we introduced the 'Controlled Document Management' web application, available in this role.

The 'Controlled Document Management' application is available in both on-premise and 
on-cloud environments.

Let's take a closer look at the steps of the 'Controlled Document Management' app and how they support the key elements of an effective Document Control process:

Step 1 - Document Creation  

In the 'Controlled Document Management' app, we use standardized templates to create Controlled Documents. 
All the information defined at the template level is automatically inherited by any controlled document created from that template.

The template includes the following elements:

• One or more files that make up the document content.
• Library Classes and Bookmarks- if specified in the template, the new document is automatically classified in the relevant Library Classes and added to the designated Bookmarks.
• Training details, including the Training Coordinator.
• Periodic Review, including the review interval and the assigned Subject Matter Expert.

• Approval Questionnaire, used to dynamically determine the right approvers for the document, based on the responses provided.
  To learn more about Questionnaire, please refer to the following blog:
  Working with Questionnaire in 'Controlled Document Management' Application
  
  The following video illustrates the 'Controlled Document Creation' process using a template:

  

Step 2 - Review & Approval

A formal approval process is mandatory in order to promote the Controlled Document to the ‘Approved’ state. It is used to verify document accuracy and compliance before release.
ENOVIA supports approval processes through:

• Approval Routes 
• Change Actions.

As part of the approval process, a signature is crucial, especially for regulated industries.
ENOVIA offers an Electronic Signature method, which is legally equivalent to handwritten signature. The authentication is handled through 3DPassport, using the user name and password.

To learn more about Electronic Signature, please refer to the following blog:

Electronic Signatures (ESIGN) for Task approval process

The following video illustrates the 'Approval Process' of Controlled Documents using an approval route:

Step 3 - Revision & Access Control 

Release & Effectivity Date

This step focuses on the process of releasing a document and managing any prior revision.
It ensures proper control of document revisions, effectivity, and supersession so that only the current, approved revision is used.
Releasing a Controlled Document means making it officially effective and available for use. Before a document can be promoted to 'Released' state, the date on which it becomes valid for use must be defined.

This is established in the 'Controlled Document Management' app by setting the Effectivity Date, which is available in the ‘Controlled Document Information Panel’ of the Controlled Document under the ‘Document Effectivity’ tab.

 

To learn more about Approval and Release process, please refer to the following blog:

Approval and Release Process for Controlled Documents

Superseded

When releasing a new revision of a Controlled Document, it is essential to determine how the previous revision will be managed.

This is controlled through the ‘Supersede Previous Revision on Release of Document’ setting, which can be found in the ‘Collaborative Space Configuration Center’ under the ‘Controlled Document management’ section.

• By default, this setting is OFF, meaning the previous revision remains in the 'Released' state until it is manually updated.

• When the setting is ON, the system will automatically move the previous revision to the 'Superseded' state as soon as a new revision is released.
   

  

The 'Superseded' state indicates that a document revision is no longer current or valid because it has been replaced by a newer revision.
Superseded revisions remain in the system to maintain traceability and meet audit requirements.

The following video illustrates how to set the Document Effectivity and release the Controlled Document:

Step 4 - Distribution

This step focuses on ensuring that relevant users are notified, trained, and provided controlled access to the latest approved document revision.
This is supported in the 'Controlled Document Management' app through automated PDF rendering and integrated training features.

PDF Rendering

PDF rendering is a core capability within the Controlled Document process. It converts a Controlled Document into a standardized, read-only PDF format, ensuring secure distribution, consistent formatting across the organization, and compliance with regulatory or internal requirements.

Using the 'Controlled Document Management' app, Administrator can tailor the final PDF appearance by configuring elements such as headers, footers, watermarks, overlays, and cover pages.

The 'Controlled Document Management' application provides a predefined PDF Render Configuration. Administrators can use it as-is, modify it, or create new configurations to meet specific organizational needs.
 

When working on the cloud, the system automatically generates the PDF. It stays up to date with any changes and is available for review, or distribution in the Information panel of the controlled document under the Derived Output tab.

Note : in an on-premise environment the generating of the PDF is a manual operation.

Training

In the 'Controlled Document Management' app, the ‘Training Required’ checkbox is available both at the Template level and on each individual Controlled Document.
When selected, it indicates that a training is mandatory for the document.
Once the document reaches the 'Approved' maturity state, the assigned Training Coordinators are notified that the document is ready and training can be scheduled.

To support training tracking, you can use the relevant APIs available for integration with LMS (Learning Management System) platforms.

The following video illustrates the 'PDF Rendering' process: 

Step 5 - Scheduled Reviews and Updates 

In this step we conduct scheduled reviews to confirm documents remain accurate, effective, and aligned with current processes, regulations, and best practices.

This is supported in the 'Controlled Document Management' app through Periodic Reviews, which are scheduled checks.

To enable this process, you need to enable the Periodic Review in the ‘Periodic Review’ tab and define the:

• The Periodic Review Interval: which is the number of months between reviews
• The Subject Matter Expert (SME): who is the user responsible for the periodic reviews.
  
   

At scheduled intervals, the SME reviews the document and either:

• Approves it as-is, confirming it’s still valid
• or submits it for updates if changes are needed.

Every decision is documented and traceable

The following video illustrates the 'Scheduled Reviews and Updates' process: 

Step 6 - Obsolescence, Retention & Archiving

Maintain full traceability by securely archiving historical revisions and preventing unintended use of obsolete or outdated information.

The 'Controlled Document Management' app enables you to utilize the 'Obsolete' maturity state to indicate that the controlled document is no longer valid for use and must not be referenced. 

To promote a controlled document to 'Obsolete' maturity state, a formal Change Action is required to ensure traceability and proper approval.