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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.

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Validation Is Stuck in the Past — and Holding Back Pharma Innovation

Nov 6, 2025 9:00:04 AM | Explore how automated validation tools and AI-driven software are reshaping pharma’s approach to speed, quality, and compliance in CSV, CSA, CQV.

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Validation Is Stuck in the Past — and Holding Back Pharma Innovation

Explore how automated validation tools and AI-driven software are reshaping pharma’s approach to speed, quality, and compliance in CSV, CSA, CQV.

Illustration showing the risks of manual cleaning validation in pharma, with FDA 483 warning, checklists, and digital dashboards

Why Modernizing Cleaning Validation Is Crucial for Compliance

Learn why cleaning validation in pharma is under regulatory scrutiny and how replacing manual processes with digital tools strengthens compliance.

Technician with tablet in front of clean bioreactors, representing cleaning validation in pharma and compliance with FDA cleaning validation guidelines

Is Your Cleaning Validation Stuck in the Slow Lane?

Discover what cleaning validation is in pharma, why it's required, and how digital tools help you meet FDA cleaning validation guidelines efficiently.

7 Reasons to Embrace AI-Enabled Digital Validation

AI-enabled digital validation can transform your processes, reducing errors, accelerating timelines, and ensuring compliance with evolving regulations.

Person on a rocket, symbolizing MilliporeSigma’s rapid 97-day digital validation journey with ValGenesis VLMS

Launching Digital Validation: MilliporeSigma's 97-Day Implementation Success Story

Discover how MilliporeSigma achieved rapid digital validation implementation with ValGenesis VLMS, transforming efficiency and compliance in just 97 days.

A comparison showing stacks of hard-copy spreadsheets used to manage a requirements traceability matrix alongside an automated requirements traceability matrix displayed on a computer screen

The Benefits of Automating Your Requirements Traceability Matrix

Automate your requirements traceability matrix to improve efficiency, reduce compliance risks, and streamline validation for better audit readiness.

Catalent's Journey of Continuous Improvement for CSV Excellence

Learn how Catalent scaled CSV compliance with ValGenesis VLMS to enhance global IT operations.

Women points to the words digital validation with background icons illustrating the benefits of automation.

4 Conversations to Drive Your Business Case for Digital Validation

Learn how to build a compelling business case for transitioning to digital validation with four key conversations that drive stakeholder buy-in.

Types of Validation in the Pharmaceutical Industry

All systems, equipment, and processes that have GxP impact require validation. Here are the different types of validation in the pharmaceutical industry.

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 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.

How Spreadsheets Create Compliance Risks: An Auditor's Perspective

Spreadsheet tools like Excel raise a regulatory red flag and can trigger an audit. Your best defense is a validation lifecycle management system (VLMS).

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.

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)

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.

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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-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.

Previously

Catalent's Journey of Continuous Improvement for CSV Excellence

Validating Pharma 4.0 for Smart Manufacturing

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