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Regular posts covering guidance changes, inspection findings, data methodology, and Redica product updates.

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Regular posts covering guidance changes, inspection findings, data methodology, and Redica product updates.
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Redica Responds: Clinical Investigators and Paper Record Controls

August 10, 2022
Redica Systems
clinical investigator
Data Integrity
GCP
gcp inspections
Redica Responds

What Are Medical Device Design Controls? A Complete 2025 Guide

August 9, 2022
Redica Systems
BIMO
Combination Products
design controls
Devies
FDA
Conference Spotlight

An FDA Perspective on Decentralized Clinical Trials: Part II

August 4, 2022
Jerry Chapman
ALCOA
Anne Johnson
Data Integrity
DCT
decentralized clinical trials

Redica Responds: Cleaning Validation 483 Observations

August 3, 2022
Redica Systems
483
cleaning
cleaning validation
Redica
Redica Responds

What to Look for in a CMO

August 2, 2022
Rebecca Stauffer
101
CMO
contract manufacturing
contract manufacturing organization
risk management
Conference Spotlight

An FDA Perspective on Decentralized Clinical Trials: Part I

July 28, 2022
Jerry Chapman
Anne Johnson
BIMO
clinical trials
DCT
decentralized clinical trials

Redica Responds: Repeat Observations by Region

July 27, 2022
Redica Systems
483
483 observations
FDA
Redica
repeat observations

Human Factors and Usability for Medtech Products

July 26, 2022
Rebecca Stauffer
101
Alison Sathe
Combination Products
Devices
FDA

On-Demand Webinar | A Fresh Take on Pre-Approval Inspection Data

July 25, 2022
Redica Systems
Michael de la Torre
PAI
pre-approval inspections
Redica
Small Pharma
Conference Spotlight

From Data Integrity to Data Culture

July 21, 2022
Rebecca Stauffer
2022 PDA Annual Meeting
clinical research organization
CROs
data culture
Data Ingegrity

Redica Responds: How Many Change Control 483s Over the Last Ten Years?

July 20, 2022
Redica Systems
483
change control
change management
FDA
Redica

A Short Guide to GMP Process Validation

July 19, 2022
Rebecca Stauffer
101
2011 process validation guidance
CMO
contract manufacturing organization
FDA
Conference Spotlight

Five FDA Warning Letters Issued in Four Years for Fraudulent Cancer Drug

July 14, 2022
Jerry Chapman
BIMO
CDER
clinical hold
clinical trial monitor
clinical trial sponsor

Redica Responds: Contamination Control 483s

July 13, 2022
Redica Systems
483
Contamination
contamination control
cross-contamination
Redica

Medical Device UDI Requirements: What You Need to Know

July 13, 2022
Rebecca Stauffer
101
483
Devices
FDA
medical device supply chain

Invest in Tech to Avoid Data Integrity Issues

July 7, 2022
Rebecca Stauffer
Data Integrity
data integrity in the lab
GMP
pharma quality
Redica

Redica Responds: How Can I Compare Enforcement Histories for CMO Sites?

July 6, 2022
Redica Systems
CMO
contract manufacturing organization
contract operations
Redica Responds
Redica Systems

What Can Trigger a CAPA?

July 5, 2022
Rebecca Stauffer
101
CAPA
Devices
FDA
FDA inspection

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