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Welcome to the ValGenesis blog, your resource for timely insights from industry-leading experts on the trends, best practices, and new technologies impacting the life sciences.

Latest News

ValConnect 2022 – Day One Round-Up

Apr 12, 2023 11:11:12 AM | ValConnect 2022 is off to a great start! Today's agenda featured live product demos and a keynote from Roche/Genentech. Here's a recap of day one.

ValConnect 2022 – Day One Round-Up

Welcome to day one of ValConnect 2022! We’re off to a great...

Commissioning and Qualification Validation in the Life Sciences Industry

Commissioning and Qualification is a critical regulatory...

Transitioning From CSV to CSA

Changes are challenging, and in the digital world what we...

The X Factor for Successful Digital Transformation in BioPharma: People

Digital transformation isn’t all about technology. To...

4 Life Sciences Lessons from the PAT to QbD Journey

During and after the COVID-19 pandemic, prevailing chaos in...

Cleaning Validation Stage 2: Performance Qualification

The second stage of the validation lifecycle is called...

Cleaning Validation Pain Points & How to Solve Them Through Digitization

Product contamination due to insufficient cleaning...

FDA's Computer Software Assurance (CSA) – Part 1 of 3

This blog is the first of a three-part series focused on...

Finding the Root Cause in mAB Production: a ValGenesis Story

Learn how we helped a customer find the root cause of a...

Boost Efficiency with Digital Equipment Qualification and Validation

Equipment qualification and validation (EQ/V) has always...

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.

Previously

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.

Previously

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.

Previously

The Pharma 4.0 Vision for Manufacturing Intelligence

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