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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

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

Apr 26, 2023 10:47:37 AM | This post highlights the benefits and limitations of 3 types of QRM tools (simple brainstorming tools, simple risk analysis tools, and complex risk classification tools) and provides suggestions for their ideal application.

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

This post highlights the benefits and limitations of 3 types of QRM tools (simple brainstorming tools, simple risk analysis tools, and complex risk classification tools) and provides suggestions for their ideal application.

Requirements Management 101: Tips for Writing Good Requirements

Writing good requirements during the requirements management process is the key to better product quality, accelerated development, and less rework.

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

In this blog post, we want to discuss about the application of the Quality by Design for Cell & Gene Therapies. Are they suited for them?

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

A light story about how ValGenesis joining on a quest to finding the root cause of a deviation in a process, how did we do it and what came of it.

Your Guide to Computer Software Assurance (CSA)

Is CSA the new CSV? Not exactly. Here's your comprehensive guide to computer software assurance, the FDA's new framework for validating software systems.

Is Analytical QbD the Future of Method Development?

This blog post will give you an overview of Analytical QbD and why it's important to implement it in your method development.

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

The efficiencies gained, according to ValGenesis customers, range from 50% to 80% improvements. This lessens demand and allows more time to be focused on higher priority tasks. Knowing the ValGenesis VLMS ensures controls and standards are followed, according to customer-specific requirements, stakeholders are given a high-degree of assurance that Quality is ingrained in the process.

How to Align Analytical QbD With the new ICH Q14?

How to connect already existing AQbD with the new ICH Q14? Jean-François Dierick and Claudia Magagnoli from GSK explained us how!

12 Reasons to Transition to a Digital Validation Process, Part 2

Paper-based workflows have been the industry standard for validating systems and processes. But companies gain many benefits from going digital. (Part 2 of 2)

Does Quality Culture Affect pQMS Outcomes? Absolutely.

This post examines the crucial impact quality culture has on individuals, organizations, and processes; it offers tips for improving it in your company.

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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