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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

Medical Device Risk Management: Should You Digitalize Your Process?

Feb 25, 2026 4:34:04 AM | Transform medical device risk management by digitalizing processes, improving compliance, efficiency, and collaboration while reducing errors and audit challenges.

All Blog Posts

Medical Device Risk Management: Should You Digitalize Your Process?

Transform medical device risk management by digitalizing processes, improving compliance, efficiency, and collaboration while reducing errors and audit challenges.

Digitalizing Pharma Control Strategies: A Roadmap

Transform pharma manufacturing with digital control strategies. Learn how to enhance product quality, streamline processes, and ensure regulatory compliance.

A person drawing a manufacturing process on a whiteboard in a pharmaceutical lab. The scene includes a table with test tubes, and lab equipment.

Better Pharmaceutical Development: A Case for ValGenesis iCMC

See how ValGenesis iRisk transforms pharmaceutical development by integrating QbD and AQbD, streamlining processes, improving quality, and expediting approvals.

Should You Use QRM Software for ICH Q9 (R1) Compliance? Yes!

Quality risk management software ensures compliance with ICH Q9(R1) guidelines, enhancing risk assessments, decision-making, and product safety in pharma.

Excel spreadsheet with overlay screenshot of ValGenesis risk management platform

Let's Move Beyond Spreadsheets for Risk Management

Discover why Excel is no longer sufficient for effective risk management in the pharma industry and why transitioning to specialized software is crucial.

Digital Quality Risk Management: A ValGenesis Story

Learn about ValGenesis iRisk, an advanced tool for digital quality risk management, and its impact on vaccine development at a top biopharma company.

Build an Effective Data Integrity Program with Risk Management

Understand why data integrity problems occur, and learn how to build an effective, risk-based corporate data integrity program to address them.

6 Ways to Make Your Risk Management More Effective

Improve the efficacy of your risk management process with these 6 strategies inspired by the ICH Q9 quality risk management guideline.

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.

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.

Are You GMP Annex 1 Revision Ready?

Learn about the requirements of the Annex 1 revision and how to ensure compliance with a digital risk management platform.

It's Time to Implement ICH Q9(R1)

In this blog post we'll look into what steps you may need to take to make sure you are compliant with the ICH Q9(R1) guideline.

Illustration of a professional holding a tablet next to a gauge meter, with icons of a brain, flowchart, and data table representing quality risk management tools

The 3 Types of Quality Risk Management Tools Used in Pharma

Explore the three types of quality risk management (QRM) tools in pharma and learn how to assess, prioritize and control risk across the product lifecycle.

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.

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

Tech Transfer & Process Scale-up

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-Based Cleaning Validation: A Lifecycle Approach

Cleaning Validation

Risk-Based Cleaning Validation: A Lifecycle Approach

Explore the evolution of pharmaceutical cleaning validation from compliance-focused practices to a risk-based, lifecycle-driven approach.

Kenneth Pierce

Written by
Kenneth Pierce

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

The Benefits of Automating Your Requirements Traceability Matrix

Catalent's Journey of Continuous Improvement for CSV Excellence

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

The Real Cost of Bottlenecks: Why Manual Cleaning Validation Increases Regulatory Risks

Digital Cleaning Validation: From Lifecycle Control to Real-Time Assurance

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.

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