Montrium eQMS /

Get organized with streamlined document control management

Manage and control quality documentation on the industry's easiest-to-use document control software. Streamline document drafting, review, approval, and obsolescence with automated workflows and task creation, including FDA 21 CFR Part 11-compliant electronic signatures.

document control software

Keep the heart of the quality system beating

Quality documents are at the center of how your organizations functions. Whether it be procedures and policies guiding your team, or reports and records that demonstrate compliance, robust document control is the centerpiece to your quality system. Digitize and streamline your workflow with a quality toolbelt built for the scaling life science organization.

Streamline your document management process

Workflow automation drives the development of quality content from start to finish, giving you the control you need for compliance—but all of the flexibility and agility you need to make things happen.

Create new documents from existing templates to speed up document creation

Collaborate in real-time with native integrations with Microsoft Office

Implement an end-to-end workflow for remote collaboration, review, document approval, training release, and completion

Find the content you’re looking for quickly with full document search

Ensure compliance with
FDA 21 CFR Part 11 &
Annex 11

Say goodbye to risky document management processes that put compliance in jeopardy. All of Montrium’s solutions are engineered to enable you to comply with the relevant regulatory requirements, including 21 CFR Part 11.

Built-in compliance with validated 21 CFR Part 11 eSignatures

Easily navigate through document versions with complete version control

Records center archive with full audit trail functionality

Complete document control from draft
to effective

Take the guesswork out of document collaboration and centralize your team in one working area to ensure everyone’s working on the same content. Say goodbye to ambiguous file names and painfully long email threads, and say hello to the best document management software you'll ever use.

Built-in version control to ensure everyone’s working on one version of the truth

Ensure complete traceability of content, including secure audit trails

Provide records of compliance to auditors within the system or through exports

Drive ALCOA+ principles home and implement new benchmarks for your team

Core capabilities

Document template center & file plan

Streamline document management and accelerate the process of creating and filing documents with a dedicated template center.

Real-time collaborative authoring

Remove friction in the document writing and review process by taking advantage of real-time, collaborative authoring without sacrificing document control.

Configurable review & approval workflows

Maximize efficiency when it comes to creating documents, and reviewing and approving changes by using intelligent workflows.  

Configurable document types & sub-types

Be in complete control of all of your documents by being able to dynamically manage the different types, their settings, and their workflows.

Native integration with Microsoft Office

Seamlessly connect your quality environment the same way your teams already collaborate and draft with our integration with Microsoft Word.

21 CFR Part 11 & Annex 11 electronic signatures

Sign documents in the blink of an eye with digital signatures that are fully compliant with 21 CFR Part 11 and Annex 11 supported by Adobe Acrobat Sign.

Google-like search & retrieval tools

Make finding and retrieving documents as simple as looking up a nearby restaurant with Google-like search tools. 

Records center for archiving

Easily keep track of all your documents with a digital records center designed to make archiving a breeze.

Built-in PDF conversion engine

Speed up file conversion and avoid third party tools by leveraging a built-in PDF conversion engine. 

FAQs about our document control software

What is document control software?

Document control software is a category of software that helps life science organizations manage and control the life cycle of procedures, SOPs, and other quality documentation. Document control software is essentially a document management system that streamlines business processes for the creation, revising, approving, and distribution of controlled documents. Document control software is typically a module of a larger quality management software platform.

 What is an example of a controlled document?

Controlled documents come in all shapes and sizes, but the term normally refers to documents where the lifecycle (creation, revision, approval, and distribution) is completed in a controlled and documented fashion with the appropriate traceability and audit trails. Document management solutions like a document control software can help centralize critical documents for distribution and improve document sharing within a regulated organization. Some examples of controlled documents could be standard operating procedures (SOPs), policies, work instructions, quality manuals, job descriptions, and much more.

What types of documents can be stored in Montrium's document management software?

We're driven to free our customers of the long and arduous manual processes that are holding them back. Within our robust document management solution, customers have the flexibility to define their own set of document types they want to manage, even powering tasks and notifications through workflow automation. These built in automation tools allow for collaborative document management and drafting Microsoft office or Microsoft Word, then allowing for the auto-distribution of draft documentation for review and approval without ever leaving the application. Whether you're managing your companies procedural documentation or sensitive documents that require access control, our platform provides you with the tools to modernize your quality processes.

Does Montrium's document control software support file sharing?

Content portability is incredibly important to us, which is why all of our products are packed with functionality that supports file sharing and document sharing natively. Whether you're looking for some feedback on a document you've drafted or looking to export a report for management, you're data remains your data at all times.

How do you store documents securely and maintain compliance?

Your documentation and the content that lives within it is protected at all times. Through robust access controls, permission management, and built-in security measures, you can sleep soundly at night knowing that our document management software will keep your documentation safe. All of our products are engineered to maintain compliance with applicable regulations like 21 CFR Part 11, and delivered in a pre-qualified state to maintain validation.

Does the document management software support customizable workflows?

One of the biggest benefits of moving to a document management system is the workflow automation capabilities that are built-in. Configure the workflow parameters on a document-type basis, streamlining the process your different documentation goes through. Automate the scheduling of periodic reviews with built-in notifications and tasks to ensure compliance with your procedures.

What is the difference between quality document control software and a document management software?

Ultimately, they both provide the same functionality, and in many circles, they're considered to be the same. However, document control software is typically used to control the request and change control component of quality documentation. Document management software, or a document management system, can sometimes be larger in scope and provides basic functionality for the drafting, review, and approval of documentation, but lacks the change control and request process.

Is Montrium's document management software built for the enterprise?

Montrium's document management software is engineered to provide all of the baseline functionality required for scaling organizations to modernize document control processes. However, we've packed a wealth of functionality designed specifically for larger organizations who require more flexibility and scalability. As an enterprise document management software, you'll be able to gain access to the tools you need to take your first steps into quality management software, as well as the functionality you'll need as you grow.

Connects to our other
QMS applications

Document Control Module

Make manual paper filing and excel trackers a thing of the past

Training Management Module

Get real-time oversight on training gaps and ditch tedious excel trackers and manual follow-up

Incidents & Deviations Module

Centralize and manage all quality events from report to action with full control.

CAPA Management Module

Centralize and manage all quality events from report to action with full control.

Change Control Module

Reduce the burden of make managing change in your organization with complete oversight and traceability

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Secure & private by default

We take the responsibility of helping you manage clinical trial data seriously. That’s why security and compliance are key focus areas for our organization and product development.

Rapid implementation & validation

Implementing software in the life sciences has changed dramatically.
Leverage our team of industry vets as we guide you from zero to eTMF hero in
as little as 4 weeks.

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