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How can CSA Simplify Your Validation Processes

Apr 12, 2023 11:11:26 AM | A better resource use, a simpler process, and a superior product quality. These are some of the CSA benefits explored in this blog post.

How can CSA Simplify Your Validation Processes

Recently, the FDA issued the draft of a new guidance for...

Developing a Retrospective QbD: a ValGenesis Story

Who doesn’t like a good story? Well, we have another for...

Types of Validation Processes in the Life Science Industry

Validation is a global regulatory requirement for the life...

How Computer Software Assurance Will Impact Traditional CSV Testing

This is the fourth post in a series of five summarizing a...

Removing Subjectivity in Risk Assessments

Subjectivity in Risk Assessments and Quality Risk...

Computer Software Assurance (CSA): What's All the Hype?

It seems like everyone is talking about computer software...

Challenges on Comparability Studies on Early Development Stages

During biopharma process development, there are often...

Risk Management for Medical Devices

Leveraging Technology to Address the ALARP vs AFAP Challenge

Q&A About Compliant, AR-Driven Hands-Free Validation

Q: What is Hands-Free Validation?


A: Hands-free...

New ICH Q14 Guideline: key Implementation Aspects

The International Council for Harmonisation (ICH) released...

Featured Content

Finding the Root Cause in mAB Production: a ValGenesis Story

Root-Cause Analysis

Finding the Root Cause in mAB Production: a ValGenesis Story

Learn how we helped a customer find the root cause of a problem in monoclonal antibody (mAB) production and become stronger.

Sofia Santos

Written by
Sofia Santos

How to Accelerate Process Scale-Up With Effective Tech Transfer

Process Digitalization

How to Accelerate Process Scale-Up With Effective Tech Transfer

There's a need to accelerate pharma product development and process scale-up. Having an effective tech transfer strategy can help you.

Sofia Santos

Written by
Sofia Santos

Risk and Data as Knowledge Enablers: A Lifecycle Approach

Quality Risk Management

Risk and Data as Knowledge Enablers: a Lifecycle Approach - ValGenesis

Read the industry insight on the topic of Quality Risk Management

Sandra Silva

Presented by
Sandra Silva

Trending Topics With ValGenesis Customers

CSV and the Shift to CSA

CSA flips the paradigm of traditional CSV to "right-size" validation processes. Learn more about the benefits and principles of the CSA approach, which encourages critical thinking and automation.


Your Guide to Computer Software Assurance (CSA)

FDAs Computer Software Assurance (CSA) – Part 3 of 3

Cleaning Validation

Learn how digitization offers a consistent way to carry out cleaning validation lifecycle activities, ensuring your methods and procedures are risk-based and rooted in scientific evidence.


Maximize the Use of Technology to Access Real-Time Clean In Place Data

Cleaning Validation Stage 1: On a Quest for Process Understanding

Pharma 4.0

Waves of new technology and thinking — IoT, AR, cloud, Agile — are transforming the very foundation of validation processes. Learn how to leverage them in a Pharma 4.0 world.


The Pharma 4.0 Vision for Manufacturing Intelligence

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