Blog Posts

Blog

What Is Quality Intelligence? How is Data Governance a Key Enabler?

Redica Systems
Blog

Farewell FDAzilla.com

Redica Systems
Blog

Avoiding the Trap of a Data Swamp

Jon Falker
Conference Spotlight

Drug GMP Warning Letter Issued Without Facility Inspection

Jerry Chapman
Blog

Unique IDs for Life Sciences Quality and Regulatory Data – Redica ID vs. FEI

Jon Falker
Blog

At GMP by the Sea, Redica Systems Corroborates FDA Example on the Spot

Redica Systems
Conference Spotlight

Looking Outside Your Four Walls at GMP by the Sea

Redica Systems
Blog

Welcoming Roger Angarita as Redica Systems’ New Chief Product Officer

Redica Systems
Blog

Expert Interview: The Role of Data Operations Inside Quality and Regulatory Intelligence

Jon Falker
Blog

Expert Interview: The CTO’s View of Quality and Regulatory Intelligence for Life Sciences

Jon Falker
Blog

Expert Interview: How Redica Systems Serves Medtech

Jon Falker
Conference Spotlight

FDA Post-Warning Letter Meetings are Not Agency Consultations

Jerry Chapman
Blog

What is “Quality and Regulatory Intelligence”?

Redica Systems
Blog

How Redica Systems Goes Further than the FDA Data Dashboard

Redica Systems
Blog

Audience Q&A: From Legal Considerations when Interacting with the FDA Webinar

Redica Systems
Blog

A Deep Dive into Cell and Gene Therapy Regulatory Considerations: Part Four

Jerry Chapman
Blog

Legal Advice for Before, During, and After an FDA Inspection

Redica Systems
Blog

Internal Audit Reports: Can the FDA Take a Peek? Part 2: Other Agencies

Jerry Chapman
Blog

Expert Commentary | China Updates Clinical Trial Guidance on “Safety Information Assessment and Risk Management Work Procedures”

Jerry Chapman
Blog

Expert Commentary | Updates to FDA’s Manual of Policies and Procedures (MAPP)

Jerry Chapman
Blog

Expert Commentary: FY2022 Report on the State of Pharmaceutical Quality

Jerry Chapman
Blog

A Deep Dive into Cell and Gene Therapy Regulatory Considerations: Part Three

Jerry Chapman
Blog

On-Demand Webinar: Insights on API Inspection Deficiencies

Redica Systems
Blog

Peter Baker’s Roadmap to Quality Intelligence

Redica Systems
Blog

A Deep Dive into Cell and Gene Therapy Regulatory Considerations: Part Two

Jerry Chapman
Blog

On-Demand Webinar: Legal Considerations when Interacting with the FDA

Redica Systems
Blog

Redica Responds: What are Common Laboratory Inspection Findings?

Redica Systems
Blog

A Deep Dive into Cell and Gene Therapy Regulatory Considerations: Part One

Jerry Chapman
Blog

Internal Audit Reports: Can the FDA Take a Peek?

Jerry Chapman
Blog

Audience Q&A: From Data Integrity and Quality Culture Webinar

Redica Systems
Blog

Is Raw FDA Data Skewing Your Analyses?

Redica Systems
Blog

On-Demand Webinar: Quality Intelligence: from Information to Knowledge

Redica Systems
Blog

Beyond Data Integrity: Ulrich Köllisch on Building a Culture for Tomorrow’s High-End Data Tools

Redica Systems
Blog

Should ICH Tackle Standard Development for CGT Products?

Jerry Chapman
Blog

What Are Inferred CFR Codes?

Jerry Chapman
Blog

On-Demand Webinar | Comparing Inspection Observations between FDA and Health Canada

Redica Systems
Blog

Does Your Lab Instrumentation Adhere to Data Integrity Requirements?

Rebecca Stauffer
Blog

FDA on the Evolution of Biologics Inspections: Part III

Jerry Chapman
Blog

The “O” in ALCOA

Guest Author
Blog

How “Inevitable” Data Integrity Issues Cause Havoc: Part II

Redica Systems
Blog

FDA on the Evolution of Biologics Inspections: Part II

Jerry Chapman
Blog

FDA on the Evolution of Biologics Inspections: Part I

Jerry Chapman
Blog

Instant Download: Insights on Quality from FDA Leaders

Redica Systems
Blog

Quality Week 2022: A Global Celebration of Quality

Rebecca Stauffer
Blog

On-Demand Webinar | Data Integrity and Quality Culture

Redica Systems
Blog

The Evolving Clinical Trial Ecosystem

Jerry Chapman
Blog

Persistent Non-Compliance Leads to a Consent Decree

Jerry Chapman
Blog

Japan’s PMDA Formalizing Post-Approval Change System Based on Recent Pilot

Jerry Chapman