A Solution to Common Compliance Challenges
We’ve built the largest 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 source our data through thousands of unique Freedom of Information Act (FOIA) requests and agency monitoring tools, and our proprietary machine learning models combine industry expertise with modern data science approaches.
Lack of Data to develop perspectives and insights?
Redica’s Solution:Data on all FDA inspected and registered sites since 2000, with more than 350,000 sites and 800,000 inspections.
20x more data than what has been released on FDA.gov—over 30,000 Form 483s, EIRs, Untitled Letters, MDSAP Reports, and 483Rs.
All FDA issued Warning Letters since 2000.
Health Canada GMP and GCP inspections and enforcement since 2012.
MHRA GMP post-inspection reports since 2005.
Disconnected and Unsearchable Agency Data?
Redica’s Solution:Retyped, linked, and searchable documents.
Thousands of man hours invested in preparing documents for intake into our process and platform.
All inspections, sites, enforcement actions, and documents cross-linked and indexed.
All documents machine-analyzed and then manually reviewed by a trained team member, retyped, and properly formatted to create an accurate, clean digital version.
No Actionable Specifics and Visualizations?
Redica’s Solution:Everything all in one place with push button reports.
Consolidated, relevant profiles of all sites, organizations, and investigators with profile summary data.
Push button reports that identify the latest trends and discrepancies from agency norms.
No Tagging and Trending of Data?
Redica’s Solution:Proprietary machine learning models.
Calculated trends by year, agency, geography, site type, and quality system area.
Over 13,000 organization trees that link all sites to organization to parents.
Over 100,000 tagged sites and organizations categories including sterile, API, FDF, CROs, clinical investigators, vaccines, etc.
Expert tagging models for human drug GMP, GVP, GCP, and medical devices that align citations with your quality system documents and SOPs.
Full coverage of Industries, GxPs, and Use Cases
Cell & Gene Therapy
Latest agency trends and hot items
Specific inspector tendencies
Benchmark to industry
Supplier research and vetting
Ongoing supplier motioning
Risk-based vs time-based audits
Audit scope improvement
Support for audit findings and SOPs, CAPAs, and change control
Support for audit findings
Audit scope improvement using latest agency trends
Comparisons of audit findings to agency citations
Research and vetting during study startup (CI, IRB, CRO)
Ongoing vendor monitoring
Audit scope improvement
“This is truly remarkable. I have never seen analytics this granular for GCP.”
“Redica is an essential tool for our quality unit. I know our team will be fully prepared if an investigator arrives at our facility tomorrow. No guesswork here. With a simple search I can have enforcement trends by specific keywords presented quickly and clearly.”
“It is really amazing what the Redica team has done and where you are going to support the industry… I couldn’t be happier with what I am getting from the platform.”
Start planning for the unexpected
Schedule a live demo with a Redica team member and discover the
resources quality and safety professionals need.