Why choose Redica Systems for Inspection Preparation?

A lack of tools and process can create inefficiencies when it comes to inspection preparation. You need automation with frictionless data and seamless workflows to evolve your process. 

In this demo you will dive into:

  • Search over 8,600 Medical Device 483s
  • Monitor supplier risk
  • Evaluate over 36,900 Medical Device sites
  • Create Personalized Reports at the push of a button
Chosen by global leaders and innovators

Get a comprehensive view

In-depth Investigator Profiles

With more than 4,500 distinct FDA Investigator Profiles containing data from proprietary research and quality-system classification, you’ll easily see how to prepare for your inspector’s tendencies and hot-button items.

Unlock insights. Be better prepared.

Enforcement Analytics includes data sets such as:
Pre-approval inspection (PAI) trends

Understand latest trends for 483 Observations on PAIs inspections – for Human Drugs, Biologics, and Medical Devices.

Internal audit and inspection planning

Base your audits and inspection planning activity on the most comprehensive and up-to-date inspection and enforcement trends and how you benchmark to the industry.

Cross-agency trends

Leverage our cross-agency tables to link citations and non-conformances to your quality system categories.

FDA Investigator Profiles

Get the details you need with the full inspection and citation history for FDA investigators.

Comprehensive Industry Reports

With the largest dataset of FDA 483s, Warning Letters, Health Canada Citations, EMA Critical Deficiencies, and more, you will have the most fact-based trends to power your inspection preparation program.

No longer “in the dark” when it comes to FDA inspection intelligence

Discover how a leading pharmaceutical company uses our data to always be prepared for agency inspections

Challenge

A global pharmaceutical firm manages 10 FDA regulatory inspections per year across its 100 global sites. They relied on tribal knowledge and consultants for inspection preparation with limited visibility into the latest agency trends and hot-buttons.

They were often caught off-guard by the idiosyncrasies of specific FDA inspectors.

“We need data-driven inspection intelligence. We don’t need anecdotes”
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Solution

For strategic planning, the client leverages our Annual Observation Trend Report to discover the latest trends in 483 Observations, providing a fact-based way to focus their planning efforts on the top-cited items.

For tactical planning, the client uses our Inspector Profiles to deep-dive into the specifics of each inspector, including their CV, their categorized observations and citation history, and how they benchmark against agency averages.
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Impact

With access to recent and historic inspection and enforcement trends, plus knowing how inspectors behave, the teams are able to prioritize their inspection prep with precision and confidence.
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Access deeper intelligence

“You just did in 15 seconds what took me and my team 3 months to do … and I trust your data more than what we did.”

“What used to take 2 months now only takes 15 seconds to do in your system.”

Director Compliance and Audit, Medtronic

“We didn’t know what we didn’t know. Now, Redica helps us be more risk-based and to refine our agenda for audits.”

“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.”

Director of Quality, Amgen