Document Management System

Simplify regulatory compliance, streamline document control, and accelerate submissions with our comprehensive document management solution.

Key Features

Our document management system transforms regulatory documentation with powerful features designed for compliance and efficiency

Intelligent Version Control

Track document versions with complete audit trails and change history for regulatory compliance.

  • Automated version tracking with timestamped audit logs
  • Document comparison with change highlighting
  • Role-based approval workflows
  • Configurable retention policies

Compliant Collaboration

Securely collaborate on regulatory submissions while maintaining traceability and security.

  • Real-time collaborative editing with tracked changes
  • Secure sharing with controlled access permissions
  • Electronic signature and approval workflows
  • Comment threading and resolution tracking

Regulatory Submission Wizard

Streamline FDA submissions with guided workflows for 510(k), PMA, and De Novo pathways.

  • Step-by-step submission guidance with regulatory requirements
  • Document templates aligned with FDA expectations
  • Built-in checklists and validation tools
  • Submission history and status tracking

Universal Document Search

Find any document across your organization instantly with powerful search capabilities.

  • Full-text search with natural language processing
  • Metadata and attribute-based filtering
  • Saved searches and personalized views
  • OCR technology for scanned document search

Compliance Standards

Our system is designed to meet the most stringent regulatory requirements

21 CFR Part 11
ISO 13485
GxP
HIPAA
IVDR
ISO 14971
GDPR
ICH
FDA QSR
ISO 9001

Why Choose AminoCloud

Compare our solution with traditional document management approaches

FeatureAminoCloudTraditional DMSPaper-Based
Regulatory Submission Wizard
SDS ManagementLimited
Real-time CollaborationLimited
21 CFR Part 11 CompliancePartial
Universal SearchBasic

Seamless Integration

The Document Management System connects with other AminoCloud systems and workflows

Ready to take control of your Documentation?

Join other medical device, pharmaceutical, and biotech companies that have streamlined their regulatory processes and document management with DocuReg.