What is Enforcement Analytics?

To truly understand global regulatory agency regulations for pharmaceutical/biopharmaceutical, medical device, and food and cosmetics firms requires knowledge of enforcement trends.  This knowledge enables quality teams to gain predictive awareness and take a proactive, risk-based approach to corporate compliance, vendor quality, and site quality.

At Redica Systems, we create actionable data intelligence that empowers global quality teams to improve compliance, improve vendor monitoring, and build a more efficient organization.  We call this tool Enforcement Analytics.

We’ve built the largest integrated dataset of inspection and enforcement documents in the world. Then, we combined it with advanced machine intelligence delivered to you via an intuitive and easy-to-use platform.  We gather our data from the world’s regulatory agencies so you don’t have to.

Plus, our proprietary machine learning models combine industry expertise with modern data science approaches.

So, how does Enforcement Analytics help quality and compliance teams?

• We have data on all FDA inspected and registered sites since 2000, with more than 350,000 sites and 800,000 inspections
• We have 20x more data than what has been released on FDA.gov including Form 483s, EIRs, Untitled Letters, MDSAP Reports, and 483Rs
• All of our information on inspections, sites, enforcement actions, and documents are cross-linked and indexed
• Our 13,000 organization trees link all sites to an organization and then to a parent
• Our experts provide calculated trends by year, agency, geography, site type, and quality system area
• And much, much more!

The Redica Systems Enforcement Analytics platform includes human drugs, biologics, cell and gene therapies, 503B outsourcing companies, animal health, food, supplements, herbal products, etc.  Our coverage spans GMP, GCP, GLP, and GDP.  Customers use Enforcement Analytics for inspection preparation, reviews of vendor and site quality, internal compliance audits, and ascertaining the quality of clinical sites. 

Want to learn more?  Download a webinar that shows how Enforcement Analytics can help you exceed your 2021 business goals.