How Can Enforcement Analytics Drive Business Performance?

Health agencies offer guidance on rules and regulations, but it’s how they actually enforce those rules that matter. Interpreting health agency rules and regulations requires a thorough understanding of enforcement trends. This enables quality teams to gain predictive awareness and take a proactive, risk-based approach to corporate compliance, vendor quality, and site quality.

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Redica Systems Enforcement Analytics


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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.
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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.
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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.
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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
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Bring us your challenge

Full coverage of Industries, GxPs, and Use Cases

Industries

Human Drugs
Biologics
Vaccines
Cell & Gene Therapy
HCT/P
Combo Products
Medical Device
503B Outsourcers
Homeopathic
Animal Health
Food
Cosmetics
Supplements
Herbal Products

Scope

GMP
GCP
GDP
GLP
GVP
RA-CMC
RA-Labeling
RA-Preclinical
RA-Clinical
Pharmacopoeia

Inspection Prep

Latest agency trends and hot items

Specific inspector tendencies

Benchmark to industry

Vendor Quality

Supplier research and vetting

Ongoing supplier motioning

Risk-based vs time-based audits

Audit scope improvement

Site Quality

Inspection management

Support for audit findings and SOPs, CAPAs, and change control

Training support

Compliance & Audit

Support for audit findings

Audit scope improvement using latest agency trends

Comparisons of audit findings to agency citations

Clinical Quality

Research and vetting during study startup (CI, IRB, CRO)

Ongoing vendor monitoring

Audit scope improvement

“We didn’t know what we didn’t know. Now, Redica helps us be more risk-based and to refine our agenda for audits.”
Manager of Vendor Quality, AbbVie
“We have no other way of monitoring our suppliers, none. Nothing else does this. With hundreds of suppliers, this is a must have, especially with a goal to be proactive instead of waiting for a supplier to tell us of an inspection or worse, enforcement actions.”
Leading Animal Health Manufacturer
“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.”
Top 10 Medical Device Manufacturer

Start planning for the unexpected

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

Bring us your challenge