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Blog

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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

Enhancing Continuous Manufacturing with Digital CPV Integration

Jun 1, 2023 10:39:52 AM | Learn how implementing digital CPV plans can contribute to continuous processes reaping the benefits of Industry 4.0 and digitalization.

All Blog Posts

Enhancing Continuous Manufacturing with Digital CPV Integration

Applying continued process verification (CPV) plans to...

laptop with spreadsheet

How Spreadsheets Create Compliance Risks: An Auditor's Perspective

As an auditor, it raises a big red flag when I discover...

Cleaning validation tech on tablet

Game-Changing Tech Paves Way for Better Cleaning Validation Outcomes

Cleaning validation remains a significant concern during...

The 3 Types of Quality Risk Management Tools and What They Do Best

Quality risk management (QRM) is a crucial process for...

Man typing on laptop

Requirements Management 101: Tips for Writing Good Requirements

Have you ever added the wrong ingredient to a recipe and...

Cell & Gene Therapies: is Quality by Design Ready for it?

In this blogpost, we will explore the application of...

Finding the Root-Cause in a Process: a ValGenesis Story

This is a happy story. But it’s also confidential in some...

Your Guide to Computer Software Assurance (CSA)

The upcoming draft guidance on computer software assurance...

Is Analytical QbD the Future of Method Development?

By now, we all know that Quality by Design (QbD)...

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

 

How ValGenesis VLMS fosters a Quality-Focused Culture

 

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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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