Regulated Content and Collaboration Solutions for Life Sciences

RegDocs365 is a fully 21 CFR Part 11 compliant, ready-to-use, cost-efficient content and document management solution hosted in an Audit Ready Compliant Cloud (ARCC) validated environment. As a turn-key content management solution built specifically for Life Science companies, RegDocs365 supports life science companies actively bringing drugs, biologics, or devices to market in their efforts to prepare regulatory submissions. RegDocs365 provides a Life Science focused platform for all of your workflow, dashboard and document management needs in a fully regulatory compliant fashion.

Easily streamline workflows at any stage of development through commercialization, including discovery, clinical trials, regulatory submissions, and post-market. RegDocs365 effectively centralizes and manages all digital content (documents, data, voice, and video) to create, protect, and publish in multi-sponsor environments.

With RegDocs365, you are always in a state of inspection readiness. Users can easily manage, categorize, track, and store data from multiple sites and multiple studies. In addition, long-term document retrieval and OCR capabilities allow for quick, accessible content to ensure audit ready access or regulatory requests.

RegDocs365 integrates Artificial Intelligence (AI) tools enabling auto-classification of metadata elements for eTMF and EDM reference models as well as advanced techniques for utilizing content to create intelligent reports. Whether for Form 1572 processing, or Clinical Site Green light reports these tools provide time saving capabilities for your clinical and regulatory staff.

New Functionality

RegDocs365 Intelligent Search. Powered by Docxonomy. Learn more.

Accelerate R&D with ARCC and the Domino Cloud for Life Sciences. Learn more.

The Future of Regulatory Compliance

A comprehensive solution designed to bring order within your organization

  • Highly scalable
  • Built on Court Square’s ARCC
  • Real-time collaboration
  • Multilevel security for sensitive data
  • Audit readiness
  • Up and running within weeks
  • Full audit trail and versioning for audit readiness and timely filing


A regulated content and collaboration solution for Life Sciences.


Validated & qualified hosting for Life Sciences.

AI For Life Science

Artificial Intelligence (AI) to improve Life Science business and clinical trials.

Qualification & Validation

Validation for protocols, processes and documentation.

IT Support

Fully Managed Life Science IT support services.

Manage Digital Content with One Cost-Effective Solution

ARCC puts you in control, allowing you to host and manage your applications and data in a safe and secure location that is backed up on a daily basis. Additionally, ARCC offers the ability to host multiple applications within the same environment.

Fulfill Compliance Obligations

Court Square Group understands that finding a hosting company to manage various regulatory and compliance requirements is difficult. However, our robust solutions exceed industry best practices for Life Science organizations. We can assure you and your clients who address regulatory concerns, such as 21 CFR Part 11, that all appropriate procedures are meticulously followed.

Dive In

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