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🔧 MasterControl Regulatory Excellence

MasterControl Regulatory Excellence

Automated Regulatory Submission Management.

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Overview

MasterControl Regulatory Excellence is designed to help companies navigate the complex regulatory landscape by automating and managing every stage of the regulatory submission process. It provides a centralized system for compiling, reviewing, and approving submission documents, ensuring that they are accurate, complete, and compliant. The solution helps to reduce manual errors, improve efficiency, and accelerate time to market.

✨ Key Features

  • Regulatory Document Management
  • Submission Assembly and Publishing
  • Project Management and Task Tracking
  • Electronic Signatures and Audit Trails
  • Integration with QMS
  • Regulatory Reporting

🎯 Key Differentiators

  • Deep integration with a comprehensive QMS platform
  • Strong focus on compliance and quality
  • Long-standing reputation in the life sciences industry

Unique Value: Connects regulatory processes with the overall quality management system, ensuring a holistic approach to compliance.

🎯 Use Cases (4)

Managing regulatory submissions to the FDA and other health authorities Ensuring compliance with 21 CFR Part 11 Streamlining the submission process for new products Collaborating on submission documents

✅ Best For

  • Widely used in the life sciences industry for managing regulatory submissions.

💡 Check With Vendor

Verify these considerations match your specific requirements:

  • Companies that do not require a full QMS integration may find the solution has more features than needed.

🏆 Alternatives

Veeva Vault RIM Sparta Systems Qualio

Offers a more integrated quality and regulatory solution compared to standalone RIM systems.

💻 Platforms

Web API

🔌 Integrations

MasterControl Quality Excellence ERP systems PLM systems

🛟 Support Options

  • ✓ Email Support
  • ✓ Live Chat
  • ✓ Phone Support
  • ✓ Dedicated Support (Available tier)

🔒 Compliance & Security

✓ SOC 2 ✓ GDPR ✓ ISO 27001 ✓ SSO ✓ 21 CFR Part 11 ✓ GxP

💰 Pricing

Contact for pricing

Free tier: N/A

Visit MasterControl Regulatory Excellence Website →