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FDA 21 CFR Part 11 Compliance Solution

Regulatory and Quality Success

InfoStrength 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, InfoStrength 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
InfoStrength’s capabilities include:
  • Document management
  • Project & process management
  • Quality management
  • Regulatory management
  • E-signatures
  • Issue management
  • Operational risk management
  • Collaboration tools
  • Auditability
In addition to supporting regulated businesses with InfoStrength SES, its founders also provide regulatory, quality and technology consulting services at MethodSense. When paired with InfoStrength, these services enable our clients to operate more effectively during the commercialization process and beyond.
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