Compliance Risk Management

QC Resource Planning and Scheduling

QA Resource Planning and Scheduling

Quality Dashboard for Quality Operation

 The Ultimate in Operational Performance

 

The Most Robust AI-Powered Compliance Platform for Compliance Risk Assessment & Mitigation

Smart-FDA is a cutting-edge, AI-powered compliance platform that leverages Generative AI to help pharmaceutical and life-sciences organizations stay ahead of evolving regulatory requirements.

Smart-FDA is an innovative service for FDA-regulated industries, projecting compliance risks by leveraging current and historical Form 483s, recalls, and warning letters. A company profile is used in conjunction with Generative AI to assess specific areas and overall company compliance-related risks. The platform delivers prioritized, role-relevant insights that highlight potential compliance deficiencies in order of importance—helping organizations avoid the costly consequences of noncompliance.

Smart-FDA is fully integrated with FDA Code of Federal Regulations (CFRs) for Drugs, Biologics, and Medical Devices, creating a unified, intelligence-driven risk management platform.

With intelligent reporting, Natural Language Search, and AI-driven discovery, Smart-FDA increases awareness of key industry trends that could impact your next inspection.

Our team of professionals continuously monitors new information across the life-sciences industry. Through ongoing engagement with the FDA, we obtain the most up-to-date intelligence on inspections, Form 483 observations, recalls, warning letters, and related regulatory activity.

The Smart-FDA database includes over 55,000 FDA inspections since 2008, more than 15,000 Form 483 observations dating back to 2006, and comprehensive recall data since 2012. All information is maintained and refreshed regularly to ensure accuracy, relevance, and regulatory alignment.

Contact us to learn more: info@cresultsconsulting.com

Cloud Services

Our solutions are hosted on Amazon Cloud, one of the most flexible, scalable and reliable cloud providers

Support

Our technical support is available to help you troubleshoot any issue and address challenges post implementation

Services

Implementation support, integration and post go-live help you achieve operational excellence

Implementation

Go-Live in less than a week with our compliance partner

WHAT OUR USERS SAY

  • We implemented Smart-QC in our largest lab which supports several sites, as this is the most feasible way for us to schedule over 150 analyses on a daily basis. We are using the efficiency management module and “right-first-time” as part of our quarterly and yearly review in assessing our resource performance. We have reduced our standard by 15% since system implementation and it is now fully integrated with our OPEX program and supply chain. - TEVA
  • We’ve been using Smart-QC for the past few years and have realized that when we are pressed to improve efficiency, one of the most critical components of our success is having a planning and scheduling system to augment our LIMS system and provide much needed functionalities such as budgeting, next year plans, and more. - Pfizer
  • We selected Smart-QC after reviewing 17 different internal/external solutions and have implemented Smart-QC in less than 5 months in 5 of our key sites. We have 6 more sites coming live soon. Since implementation, we have seen significant improvement in throughput, cycle time reduction, and on-time delivery in the pilot sites. Smart-QC also continues to enhance our overall lab operational excellence. Most recently, we have integrated Smart-QC with our JJ-PS JNJ Lean/Six Sigma program to further enhance our overall performance. –Johnson & Johnson
  • Smart-QC was part of an overall corporate strategy to address the overall planning and scheduling processes in our QC Laboratories. Since the deployment of Smart-QC, we have realized a major reduction in cycle time and improvement in our on-time delivery. Our management team is using the Smart-QC executive dashboard on a weekly basis and we are using the planning module to enhance the overall network capacity. -Biogen

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