Category: ISO

Maintain document control.

Medical device document management and control is essential for an effective quality management and regulatory compliant system, especially as your product pipeline expands toward commercialization goals. To meet these challenges head on, it’s vital to manage information across your entire operation, ensuring regulatory compliance including: FDA 21 CFR Part 11 regulations; ISO quality standards; Sarbanes-Oxley Act requirements; and other regulations.

What are some of the key elements of a central repository for all your critical business information? Your document management system must allow you to:

  • Create a searchable library of business and regulatory documents.
  • Organize and control critical content.
  • Demonstrate authenticity and non-repudiation.
  • Improve communication and teamwork across departments and teams.
  • Lower the cost of FDA regulatory compliance with electronic documents, e-signatures, version control, audit trails, and the ability to manage permissions to critical content.

The document management solution from LuminLogic has been successfully validated and inspected in FDA environments. We’ve helps companies like yours dramatically reduce the time it takes to bring a new product to market by accelerating the process for document change, approval, notification and distribution. Our easily configurable Software as a Service (SaaS) tool is designed for rapid implementation and validation, and we offer on-call Quality Support services to ensure your medical device or pharmaceutical QMS remains compliant.

Want to learn more? Contact the regulatory document specialists at LuminLogic today.

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