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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

Is Analytical QbD the Future of Method Development?

Apr 20, 2023 10:28:31 AM | This blog post will give you an overview of Analytical QbD and why it's important to implement it in your method development.

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.

What's the Difference Between a VLMS and a DMS?

If you think of validation as a pie, document authoring is 25% of the pie. A DMS can’t address the other 75% of validation activities ValGenesis supports.

Object-Oriented Validation: A Different Way of Thinking

ValGenesis (VLMS) has capitalized on delivering functionality to support object-oriented validation. Here you can create requirements as objects, and these can be shared.

How to Design a Control Strategy for Analytical Procedures

An efficient control strategy will ensure your processes performs always as expected. In this blog post we described the steps to design one.

A new Approach for Biosimilarity Assessments: a ValGenesis Story

This a story about how we helped a company with their biosimilarity assessments and to avoid massive time-to-market delay!

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

ValGenesis validation lifecycle management systems provide a solution that eliminates all the inefficiencies that plagued paper-based cleaning validation processes.

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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