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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

Object-Oriented Validation: A Different Way of Thinking

Apr 20, 2023 9:52:52 AM | ValGenesis (VLMS) has capitalized on delivering functionality to support object-oriented validation. Here you can create requirements as objects, and these can be shared.

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.

User Requirements Specification: Creating one for CSA

This post is about tips to write your User Requirements Specification and how it can improve your processed data and software.

Twelve Reasons to Transition to a Digital Validation Process, Part 1

Pharma has embraced digitization in many business lines, but validation has been one of the few processes to remain manual. Here are 12 reasons to make the switch! (Part 1 of 2)

Comparability for Post-Approval Changes

Today we want to take a fresh look into comparability for post-approval changes. How? We're thinking of a unique multiparametric approach.

Finding a Root-cause in a Filter Clogging at Drug Product Filtration

This time we tell you how we helped a company finding a root-cause in a Filter Clogging and how we solved it.  

Cleaning Validation Stage 1: On a Quest for Process Understanding

Want to learn more about cleaning validation? The use of data collection, analysis, and evaluation are the most critical tasks in a cleaning validation program.

Top 10 Benefits of ValGenesis Paperless Validation

Explore the top 10 business benefits you'll receive from digitizing your paper-based validation processes with ValGenesis.

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

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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