Managing documents in a large enterprise is like managing the office fridge: everyone puts their stuff in, nobody labels anything, and eventually you’re left with expired yogurt, mystery containers, and a passive-aggressive note from compliance.

There are likely a hundred reasons you might now be tasked with finding an Enterprise Document Management System (EDMS). Documents are buries in shared drives, desktops, and email threads. Files are duplicated, naming conventions went out the window, and audit prep takes weeks and still feels like a scramble. Reviews and approvals are managed in email chains or Excel trackers. The list goes on.

While every solution promises to be the perfect match, in a regulated industry like yours where compliance and security are critical; simple document storage won’t cut it.

This guide highlights the leading Enterprise Document Management Systems built to meet the demands of highly regulated industries like financial services, manufacturing, government, and life sciences — so you can compare, shortlist, and move forward with confidence (and finally get out of the expired-yogurt stage of your document management.)

What to Look for in an Enterprise Document Management System

If you’re evaluating EDMS platforms in a regulated environment, focus on the essentials:

Regulatory Compliance: Support for frameworks like 21 CFR Part 11, GxP, SOX, ISO 9001, and GDPR is non-negotiable.

Audit-Ready Controls: Role-based permissions, version control, and immutable audit trails are must-haves.

Scalability: Enterprise systems need to grow with your business across teams, departments, and geographies.

Workflow Automation: Manual approval chains are a thing of the past—modern EDMS platforms automate routing, signing, and task delegation.

Enterprise Integration: Look for seamless interoperability with ERP, CRM, PLM, QMS, and daily productivity tools like Microsoft 365 or SAP.

The Leading Enterprise Document Management Systems for Regulated Industries:

The CARA Platform: The Enterprise Document Management System Built for Regulated Enterprises

CARA is an AI-powered enterprise platform built specifically for regulated industries. Designed to meet stringent compliance requirements across life sciences, finance, government, manufacturing, and more, CARA delivers complete document and content lifecycle management with deep configurability and powerful automations.

Unlike general-purpose platforms, CARA comes with prebuilt support for regulations such as 21 CFR Part 11, GxP, HIPAA, and GDPR — enabling organisations to deploy faster and stay audit-ready without extensive customisation. Its end-to-end encryption, role-based access controls, and reports dashboard ensure organisations can manage sensitive content with confidence.

Why The CARA Platform stands out:

Enterprise-Ready Compliance: Validated for regulated industries with full audit trails, encryption, and permission structures.

AI Document Management: CARA AI assists with document classification, metadata tagging, search, and even summarisation — dramatically cutting time on manual tasks like search and creation.

Powerful Workflow Automation: Design and manage complex document-centric workflows with eSignatures, task assignments, and routing logic.

Content + Process in One: Combines content services and business process management in a single, unified platform.

Integration Ecosystem: Built to work with Microsoft 365, Salesforce, SAP, and other critical enterprise systems to support content as part of wider processes.

Low-Code Configuration: Adapt quickly to changing regulatory or business needs without writing code.

Microsoft SharePoint: Familiarity at Enterprise Scale

As part of the Microsoft ecosystem, SharePoint remains a core enterprise solution for content and document management. While not industry-specific, its ability to scale across large organisations and support custom compliance configuration makes it a reliable EDMS choice, particularly for companies already embedded in the Microsoft ecosystem.

Key Features:

Integrated with Microsoft 365: Seamless with Teams, Outlook, and Office apps.

Structured Document Storage: Use metadata, permissions, and versioning to manage large document volumes.

Governance Tools: Microsoft Purview and retention policies support compliance.

Customisable: Build tailored workflows with Power Automate or third-party apps.

OpenText Documentum: A Veteran in the EDMS Space

OpenText Documentum has long served as a cornerstone EDMS in industries with complex governance and regulatory needs. While can require heavier IT involvement to manage and extend, its track record in compliance-heavy environments can’t be ignored.

Key Features:

Enterprise-Grade Security & Versioning: Proven governance and control.

Customisable: Documentum has proved itself to be very customisable, allowing knowledgeable IT departments to vastly extend and deeply integrate the platform in their landscape.

Used Across Regulated Industries: Particularly in pharma, government, and manufacturing.

Content Workflows: Extensive workflows designed for document-centric processes.

Box: Cloud-Native with Enterprise Capabilities

Box has evolved beyond a simple file-sharing tool to offer enterprise-grade compliance and security. For organisations looking for cloud-first deployment, global collaboration, and strong governance, Box provides a lightweight but enterprise-capable alternative.

Key Features:

HIPAA, FedRAMP, and GDPR-ready: Enterprise plans include compliance features and content lifecycle tools.

Collaboration Focused: Ideal for dispersed teams and fast-paced work environments.

Strong API Ecosystem: Works with Microsoft, Salesforce, and hundreds of enterprise applications.

M-Files: Metadata-Powered Document Management

M-Files takes a fresh approach to document management by focusing on what a document is, not where it’s stored. This metadata-first strategy improves search, classification, and automation — all while supporting the compliance and audit needs of regulated industries.

Top Features:

Metadata-Driven Navigation: Makes it easier to find and govern content.

AI-Powered Classification: Automates tagging, categorisation, and document lifecycle actions.

Compliance: Includes core features for version control, approvals, and content lifecycle governance.

Other Enterprise-Adjacent Tools

While platforms like Dropbox Business, Google Workspace, and Zoho WorkDrive may offer document storage and basic permissions, they are still evolving players in the security and compliance features required by organisations in regulated industries.

They may serve as collaboration tools, but they are not full Enterprise Document Management Systems — especially when compared to platforms purpose-built for compliance.

The Right Enterprise Document Management System Isn’t Just a Repository

In regulated industries, your EDMS is a compliance engine, a system to drive collaboration, and a critical pillar of your digital infrastructure. In 2025, the leading systems are those that balance rich functionality with enterprise scale and regulatory compliance.

The CARA Platform delivers on all; purpose-built for compliance-heavy environments, highly configurable, and ready to integrate your real business processes from day one.

Ready to see how CARA compares? Schedule a live, personalised demo today and discover why it’s the trusted Enterprise Document Management System for regulated industries worldwide.