Category: FDA

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.

Audits without intimidation.

The healthcare industry, whether it involves pharmaceuticals, biotech treatment protocols, or medical devices, is highly regulated—as it should be. Because the FDA has been established to ensure public safety as the latest healthcare innovations are brought to market, audits will happen. They must.

But the audit process doesn’t have to be scary. LuminLogic, a 21 CFR Part 11 compliant SaaS solution that supports document, regulatory, quality, and risk management systems for medical device, pharmaceutical and biotech companies during the commercialization process, can take the stress out of audits. Our audit management software solution enables you to attain and maintain compliance by automating, streamlining, and managing the auditing process.

Not only does the FDA conduct audits to ensure your business is operating in a way that supports the approved and safe use of your products, your company sponsors and partners will perform audits to confirm that you’re supporting their regulatory obligations. So, during and after product commercialization, accurate data tracking—and your ability to show it—is imperative.

A robust audit management software solution sets a secure foundation for streamlining any audit process. When you can collect and track data with on-demand reports that identify document creation and modification specifics, you’ll be able to provide custom documented information trails to meet precise auditor requests.

“Audit” doesn’t have to be a bad thing. If you’d like to learn more about the LuminLogic audit management software solution, reach out to us today.

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