Blog

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

Open filters
Search
Tags
Author
Aditi Singhai
Alison Sathe
Anders Vinther
Anne-Caroline Boillot
Barbara W. Unger
Barry Price
Jackie Torfin
Jerry Chapman
Jon Falker
Katie Terry
Khushboo Agrawal
Mark Agostino
Michael de la Torre
Rebecca Stauffer
Redica Systems
Roger Angarita
Sarah Boynton
Scott Sherrill
Tashil Sharma
Subscribe to our Newsletter
Regular posts covering guidance changes, inspection findings, data methodology, and Redica product updates.
Trends

Non-Sterile Doesn’t Mean Low Risk: FDA Emphasizes Gaps in Microbial Control

483
Draft Guidance
FDA
Microbial Control
Non Sterile
Product Insights

Deep Dive Into Data Explorer: Your Analysis Interface

Data Explorer
inspection readiness
Redica App
Redica Systems
Regulatory Intelligence
Product Insights

Deep Dive Into Spaces: Your New Command Center

AI
AI-Powered
Redica Systems
Smart Folders
Spaces
Product Insights

Introducing the New Redica: Integrated Intelligence for Regulatory and Quality Teams

AI-Powered
DaaS
data
Data Explorer
New App
Product Insights

Redica Data-as-a-Service (DaaS): Seamless Data Integration, Where You Work

DaaS
data integration
data sharing
Data-as-a-service
snowflake

Redica Systems Closes Financing to Advance Predictive Quality and Regulatory Intelligence in Life Sciences

No items found.
Trends

FDA Flags Repeat Offender for DEG/EG Testing Failures—Is Your Supply Chain at Risk?

DEG
DEG-contaminated
DEG/EG
diethylene glycol
EG
Conference Spotlight

FDA: A Pillar of Protection for Patients and Industry

FDA
FDA Oversight
Patient Safety
Enforcement

Limiting Plant Access and Sharing Redacted Documents Results in Import Alert and Warning Letter

FDA
import alert
Inspection
Tianjin Darentang Jingwanhong
Tianjin Darentang Jingwanhong Pharmaceutical

Strategies to Improve Your CAPA Program: Addressing Key Compliance Risks

CAPA
CAPA System

What Is a 510(k) Submission? A Complete 2025 Guide

510k
510k submission

503B Outsourcing Facilities: A Complete 2025 Inspection-Readiness Guide

503A
503B
503B outsourcing

Redica Systems Successfully Completes SOC 2® Audit

No items found.

Biologics Inspection Case Studies Highlight API and Drug Product Deficiencies

API
Case Study
CDER
FDA

Understanding MHRA UK Compliance in Pharma and MedTech

No items found.

FDA Inspection Database: An Essential Tool to Prepare for FDA Inspections

FDA
FDA Database
Enforcement

Granules India FDA 483 Includes Potential Contamination and Data Integrity Findings

483
483 Findings
Data Integrity
Form 483
Granules India
Trends

MedTech 2024 Highlights: A Look at iCGM Systems and CPAP Machines

2024 highlights
CPAP Machines
FDA
iCGM
iCGM Systems