Automated Surveillance, Alerts, & Expert Analysis

This allows your team to keep stakeholders proactively informed and ensure nothing critical is missed.

  • Get automated and customized surveillance
  • Real-time alerts
  • Review expert analyses
  • Read Machine translations
  • Minimize search times and spend more time analyzing, planning, and taking critical action.

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Redica Systems External Monitoring


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Expert Daily Monitoring
3,000
Data
Sources
>65
Global Health Agencies
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Real-time alerts & updates

Intelligence Gathered by Leading Industry Experts

A critical differentiator in our External Monitoring solution is the combination of Redica’s industry-leading technology and automation with oversight and direct access to some of the best minds in the industry.

Barbara W. Unger

Senior GMP Quality Expert

Led Amgen’s Corporate GMP Audit group focused on API manufacturers, Quality Systems, and Computers. Developed, implemented, and maintained the GMP Regulatory Intelligence program for 8 years.

Jerry Chapman

Senior GMP Quality Expert

Designed and implemented Eli Lilly’s comprehensive GMP intelligence process to identify, analyze, and archive pertinent drug GMP regulations, inspection findings, trend discovery, and best practices.

Mark Agostino

GMP/Medical Device/Combo Products Expert

Experience in quality assurance, supplier quality, and regulatory affairs.

Jamie Colgan

GCP Expert

Experience in statistics, validation, audits, monitoring, validated SAS program development, GLP & GCP system evaluation, P&P writing, and set new standards for communicating audit findings.

Jane Wastl

Senior GMP Quality Expert

Served in Eli Lilly leadership and technical positions in site and corporate quality assurance, quality control laboratory, training, master scheduling, capacity planning, and six sigma.

Our Current Solution is Highly Configurable

We configure our tools to your unique monitoring objectives and data requirements. Our dynamic design capabilities ensure each user can quickly find, review, and assess critical information based on their functional area.

Stay Abreast of Critical Regulatory Signals

Traditional regulatory intelligence approaches are resource-intensive and still often miss risk signals and emerging trends. External Monitoring takes regulatory intelligence out of your hands via automated updates and regular communication about regulatory changes.

Scans and Impact Alerts From Industry Experts

Monitoring communication includes links for drill-down research while additional analysis opportunities are available for users with the Enforcement Analytics Module.

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

Get Full Access to Redica 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

Download the Special Report

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.