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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

FDA Warning Letters Expose the Risks of Using Paper Logbooks

Nov 2, 2023 11:00:00 AM | Examples from real FDA warning letters show the risks and consequences of using paper logbooks and why a digital logbook management solution is essential. 

exclamation point icon over paper logbook

FDA Warning Letters Expose the Risks of Using Paper Logbooks

Examples from real FDA warning letters show the risks and consequences of using paper logbooks and why a digital logbook management solution is essential. 

What Is Paperless Validation All About?

In this post, we'll explore the transition to paperless validation and the benefits it brings such as efficiency, cost reduction, and compliance assurance.

How Can You Simplify Regulatory Approval for PAC?

Learn how to simplify regulatory approval for post-approval changes and discover the benefits of implementing a PACM protocol and using a QRM platform.

What Changes When Your CPV Goes Digital - A ValGenesis Story

Explore the essential role of CPV in your manufacturing process and discover the transformative impact of going digital in this blog post case study.

Generative AI and Its Impact on Validation: Part 2

This post is the second installment of a two-part series on the incredible impact of generative AI, particularly ChatGPT, on validation in the life sciences.

Generative AI concept

Generative AI and Its Impact on Validation: Part 1

This post is the first installment of a two-part series on the incredible impact of generative AI, particularly ChatGPT, on validation in the life sciences.

Removing Bias from Risk Assessment

Discover how to leverage digital CPV to apply the ICH Q9 (R1) data-driven approaches and enable bias-free risk assessment in pharmaceutical manufacturing.

Risk-based CSA Validation: Ensuring the Least Burdensome Approach

The post summarizes the key principles of CSA, various testing methodologies, risk management, and the benefits of digital software validation tools.

How to Make Drug Developability Predictions With Machine Learning

Discover how machine learning unlocks drug developability predictions' potential in a successful case study.

Embracing Change: The Transition from CSV to CSA in Pharmaceuticals

Unlocking the potential of Computer System Assurance (CSA) in pharmaceuticals: A roadmap for a seamless transition from CSV to CSA.

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

6 Ts to Drive Computer Software Assurance Adoption

CRO AmplifyBio Accelerates Trial Success with Digital CSV

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

Game-Changing Tech Paves Way for Better Cleaning Validation Outcomes

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

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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