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Get the facts on vendor risk

In-depth Site Profiles

With more than 300,000 unique Site Profiles curated from primary research of multiple agencies, you’ll easily navigate through thousands of data points to gain intelligence on each Sites’ full regulatory history.

See the complete picture. Stay informed.

Enforcement Analytics includes data sets such as:
GMP Vendor Profiles

Understand your critical suppliers’ full regulatory and inspection history – from CMOs, to testing labs, to excipient suppliers, to packagers and distributors.

GCP Vendor Profiles

Understand your critical vendors’ full regulatory and inspection history – from CROs, to central testing labs, to Clinical Investigators, to IRBs.

Active Monitoring and Alerts

Save and monitor your entire vendor universe to ensure that you never miss an inspection or enforcement action.

Organization Profiles

Understand the organizational structures of your vendors, including parent/child relationships and aggregate profiles.

See the full vendor picture

Discover how a leading distributor and medical device manufacturer uses our data to help pre-qualify vendors and to actively monitor them to stay in regulatory compliance.

Challenge

With over 10,000 suppliers, one of the largest US-based distributors and medical device manufacturers needed to improve its supplier risk-assessment and monitoring program in order to ensure FDA compliance, and improve patient safety.

“We don’t know what we don’t know.”

“Vetting is labor intensive and requires travel, which is only made more difficult with COVID.”
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Solution

For supplier qualification, the client leverages our Site and Organization profiles to understand and analyze the full regulatory history of its suppliers, ensuring that it adds quality into its purchasing decisions.

For ongoing monitoring, the Redica Customer Success team helped to build a monitoring portfolio of over 5,000 suppliers. Our system automatically sends notifications for any inspection or enforcement event.
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Impact

The client experienced an immediate benefit, with a time-to-value of less than one week as an on-site audit was determined not to be necessary due to Redica’s data.

The client now has demonstrable compliance with supplier evaluation and monitoring needs.
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“This is truly remarkable. I have never seen analytics this granular for GCP.”

Clinical Quality Assurance, Johnson & Johnson

“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