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.
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.
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
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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
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Built-in version control to ensure everyone’s working on one version of the truth
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Ensure complete traceability of content, including secure audit trails
Provide records of compliance to auditors within the system or through exports
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Drive ALCOA+ principles home and implement new benchmarks for your team
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Implementing software in the life sciences has changed dramatically.
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