Machine Intelligence Layer of Enforcement Analytics

Industry professionals struggle with enforcement reports overflowing with data that take weeks or months to assemble, with no meaningful insights.  Our enforcement and inspection data, fused with powerful intelligence can:

  • Generate unique insights for better risk analysis and decision making
  • Automatically surface insights that are actionable and create value

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Improve Precision and Efficiency of Meaning Generation

Our team of regulatory and risk management experts continuously tune and improve precision and efficiency of insight generation algorithms.
1000s of hours refining our algorithms, building on the experience of our domain experts that will help detect the right signals to improve your enforcement and inspection outcomes.

Redica Systems Quality Assurance Investigator Profile

Improve Accuracy and Time Detecting Events and Analyze Trends

Eliminate manual effort and dramatically reduce time (from weeks/months to seconds) to generate insights and analyze trends.
Reduce errors and eliminate complex workflows using a reliable, repeatable, and simplified machine-driven approach.

Redica Systems Inspection Readiness Site Profile

Generate Meaning out of Enforcement and Inspection Data

Enable contextual search using the ability to parse and index large volumes of enforcement and inspection data.
Recognize intent and meaning by classifying, augmenting, and annotating data with context, topics, and themes using NLP and data-mining technologies.
Increase value and relevance of insights through fast and accurate tagging, and cross-linking inspections, Warning Letters, sites, and events in enforcement data.

Platform Features

Site Tags

We created our tags from a combination of Agency Registration data and Inspection and Enforcement activity. Tags are used in list views and reports to be able to filter and segment the data.

GxP Tagging

We use evidence from events and registrations to tag events (i.e. inspections) and sites with GxP tags. For example, if the site is registered with the BIMO database, then we know it is GCP. Also, if the site tag is Human Drugs: Manufacturing then we know that is a GMP facility

 

We support: 

  • GCP – Good Clinical Practices
  • GLP – Good Laboratory Practices
  • GVP – Good Pharmacovigilance Practices
  • GMP – Good Manufacturing Practices
Expert Tagging
  • Human Drug GMP (link)
  • Quality System (10 sub items)
  • Packaging and Labeling (4 sub items)
  • Materials (7 sub items)
  • Laboratory (8 sub items)
  • Facilities and Equipment (7 sub items)
  • Production (16 sub items)
  • Data Integrity (11 sub items)
  • Medical DeviceGMP
  • Human Drug GCP
  • Responsibility of Investigator, Institutional Review Board (IRB), Sponsor, Contract Research Organization (CRO), Sponsor Investigator
  • Food GMP
  • Human Drug GLP
  • Human Drug GVP
  • Therapeutic and Product Trees
Real-Time Enforcement Intelligence

Get the latest enforcement and inspection intelligence at your fingertips. With Redica you’ll have:

  • Up-to-date intelligence such as what citations have been issued
  • Which vendors have compliance issues
  • How do we compare with our peers

Redica also pulls enforcement and inspection signals from across a variety of sources directly into our platform so you can plan and prioritize your inspection planning and manage your enforcement citations.

 

Start planning for the unexpected

Schedule a live demo with a Redica team member and discover the
resources quality and safety professionals need.

Redica Systems Enforcement Analytics

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Quality Management Systems for Small Pharma and Biotech Firms

Webinar: QMS for Small Pharma and Biotech Firms

Presented on Tuesday, March 30, 2021
by Fenton Fong, Founder, Managing Director, & Principal at xCellarate

Download the slide deck and video of this informative 1-hour webinar on the common challenges small pharma firms face when developing a QMS.

What you will learn:

  • Common challenges small pharma firms face when developing a QMS
  • Recent enforcement trends involving the Quality Unit
  • Impact of the COVID-19 pandemic

Download the Special Report

APAC ad

In this summary we identify:

GMP data from FY2017 to FY2020 for the Asia-Pacific region

Top 3 GMP primary and secondary citations

Top 3 483 observations

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An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

In this summary we identify:

  • Data from 2019 UK MHRA Inspections
  • Trends from 2015, 2016, 2018, and 2019 inspections
  • Conclusions drawn from an analysis of drug inspection data

Experience the Power of Redica Systems

Redica Pro Free

Sign up for your FREE account today and get instant access to:

SEARCH Find the inspection records you want by inspector’s name, company name, site, city, country, etc.

WARNING LETTERS Easily search the largest database of FDA Warning Letters by date, company, FDA office, or subject

SITES Quickly assess inspection records including dates and inspectors across all of your sites

INSPECTIONS Complete list of FDA inspections by date, company, category, and country

Get Complete Access to the Redica Systems Platform

Please submit your email address and one of our team members will contact you shortly to answer all of your questions and get you started with the new Enforcement Analytics platform.

Discover the power of the most comprehensive database of 483s in existence.

Our database of over 20,000 483s is retyped and tagged, making it easy to create an Observation Report in seconds.

Eliminate days of work and get your FREE personalized 483 Observation Report.