FDA 21 CFR Part 11 Compliance Solution

FDA Regulatory Management Software

LuminLogic’s FDA Regulatory Management Software Smart Enterprise Suite (SES) is designed specifically for regulated businesses. We built it to make FDA compliance, business process management and business communication easy and efficient for life science companies. Our trusted platform addresses compliance, quality management and regulatory concerns, and, thanks to the cloud, it comes with low risk and fast results.

Founded by regulatory expert, Rita King (read Rita’s Bio), in 2000, LuminLogic was created to help life science companies comply with 21 CFR Part 11. It allows regulated businesses like yours to:

  • Operationalize critical business functions
  • Address compliance and regulatory needs
  • Radically improve productivity
  • Increase competitiveness
LuminLogic’s capabilities include:

In addition to supporting regulated businesses with LuminLogic SES, its founders also provide regulatory, quality and technology consulting services at MethodSense. When paired with LuminLogic, these services enable our clients to operate more effectively during the commercialization process and beyond.

Making it Easier for Regulated Businesses

Because your world fraught with tight deadlines and seemingly impossible regulations, we designed LuminLogic’s FDA Regulatory Management Software to support processes and systems that facilitate quality and compliance. We used our experience in technology validation to develop a product that does not have bugs, glitches or issues. Our goal is to provide the technology you need to navigate global commercialization requirements, without added hassle. Our philosophy is to consistently deliver:

  • Instant access to documents from anywhere with an Internet connection
  • A secure, centralized location for your critical business information
  • Boosted productivity and enhanced customer service
  • Improved compliance with government regulation and technology validation
ISO 13485 Quality Management System
Meet Our Leadership Team

Recognized as thought leaders in the life sciences, our senior management team thrives on solving complex issues and creating positive outcomes for our clients’ challenges.

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