Category: FDA

Stay purpose-focused (and know the details are in check).

You have vision—that’s why you are part of the medical device community. But to take your innovative ideas to fruition, there are countless regulatory hoops that must be successfully jumped through.

To keep your efforts on point, you need a project and process management system that ensures operational efficiency—and control. Robust tools will give you the optimal blend of usability and flexibility to stay informed, control project work and schedules, and keep project teams aligned with collaboration and reporting tools.

The right process management software will allow you to:

  • Determine constraints that drive the start date of a selected task and easily trace critical paths in projects/process plans to find the root cause of delays.
  • Access the most frequently used information needed to manage projects and processes with predefined reports to easily track resources, maintain costs, and communicate progress with your team.
  • Create and share master templates to easily implement processes that are pre-populated with tasks, critical content, and resources.
  • Maintain a central, secure repository for efficient storage and access to control projects processes, documents, policies and procedures.
  • Gain enterprise-wide visibility into project statuses with measurable performance metrics and improve communication and teamwork across departments and functional areas.
  • Lower the cost of regulatory compliance (such as FDA 21 CFR Part 11) with electronic documents and electronic signatures, version control, audit trails, and the ability to manage permissions to control the access and management of critical content.

Do you want a successfully validated software suite to improve market readiness and increase secure productivity? Reach out to LuminLogic today and learn how.

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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