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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.

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6 Reasons Validation Projects Fail

Apr 12, 2023 11:11:27 AM | Many validation projects go over budget or fall behind schedule. Avoid these 6 common pitfalls to ensure your next project is a success.

6 Reasons Validation Projects Fail

Many validation projects go over budget or fall behind schedule. Avoid these 6 common pitfalls to ensure your next project is a success.

How Can CSA Simplify Your Validation Processes

A better resource use, a simpler process, and a superior product quality. These are some of the CSA benefits explored in this blog post.

Developing a Retrospective QbD: a ValGenesis Story

A story about this time we helped a company in the Post-Approval Change Management of a Legacy Product using a Retrospective QbD methodology.

How Computer Software Assurance Will Impact Traditional CSV Testing

Computer software assurance (CSA) encourages the use of unscripted test methods, such as ad hoc testing, and automated technologies.

Removing Subjectivity in Risk Assessments

In this blog post we explore the topic of minimising the subjectivity in Risk Assessments through Digitalisation of processes.

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

Computer software validation (CSV) and computer software assurance (CSA) aren't all that different. So then, what's all the hype about? Let's discuss.

Challenges on Comparability Studies on Early Development Stages

This blog post goes over the key aspects of developing solid comparability studies on early development stages.

Risk Management for Medical Devices

Many medical device companies have struggled with implementing a risk management process that results in risk being mitigated to the level of AFAP.

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

AR-driven hands-free validation isn’t just a futuristic concept; it’s available now. In this insightful Q&A, Steve Thompson discusses how it will transform GMP production environments.

New ICH Q14 Guideline: key Implementation Aspects

The ICH released a draft version of the new ICH Q14 Guideline last March. This blog post will give you an overview of its key implementation aspects.

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

How Do the FDA's CSA Guidance and GAMP 5 Align?

6 Ts to Drive Computer Software Assurance Adoption

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

Five Cleaning Validation Challenges Digitalization Solves

Game-Changing Tech Paves Way for Better Cleaning Validation Outcomes

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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