The Most Robust Platform for Compliance Risk Assessment & Mitigation

FDAAWARE is an innovative service for FDA’s regulated industries, projecting compliance risks by leveraging current and historical 483s, recalls and warning letters A company profile is used in conjunction with an advanced Projection Algorithm to assess specific sites and overall company compliance related risks, providing the site’s team with potential compliance deficiencies sorted in the order of importance, to avoid the costly consequences of incompliance. Trending reports are pushed to the compliance team, centralizing their focus on up-to-date FDA trends observed in their country, specific industry, region etc., creating a continuous improvement process. FDAAWARE is fully integrated with FDA CFRs for Drugs, Biologics and Devices creating a fully aligned risk management platform.

With over 25 different reports, you can increase your awareness to various KEY industry trends that could affect your next inspection.

We have a team of professionals that constantly monitor new information about the life science industries; they are in contact with the FDA regularly and obtain the most up-to-date information about inspections, 483s, recalls, warning letters and more. Our DB contains over 55,000 Inspections since 2008, more than 15,000 483s dated from 2006, and Recall Information since 2012. Our professional team updates ALL of the above information regularly. We also have Information about more than 2,500 Inspectors and their statistics (current and historical).

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Cloud Services

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


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


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


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


  • 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