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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.

Posts about Artificial Intelligence (AI):

Scientist comparing paper records to digital dashboards using validation software for pharma.

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 comparing paper-based CQV with digital equipment validation: paper files cause delays and risks, while digital workflows enable faster, compliant, and secure validation

Reevaluating Paper-Based CQV: Why Clinging to Tradition Increases Risk

Learn how digital equipment qualification in the pharmaceutical industry reduces risk and accelerates product release by replacing paper-based CQV processes.

Map highlighting ValConnect Innovation Day 2025 locations: Princeton, Frankfurt, and Hyderabad.

ValConnect Innovation Day Princeton: A Glimpse into the Digital Future of Life Sciences

ValConnect Innovation Day Princeton brought Bayer, GSK, Cardinal Health, Transcat & Hansa Biopharma together to explore AI & Smart GxP™ in life sciences.

AI-powered CQV illustration with handshake, gears, and data dashboard for audit readiness.

Audit Pressure? Stop Last-Minute Scrambles  With AI-Powered CQV

Discover how adopting a risk-based, AI-powered approach to CQV can streamline audit readiness, reduce stress, and ensure compliance in pharmaceutical manufacturing.

Illustration of a stopwatch, data dashboard with charts, and a bioreactor vessel, representing automation and data monitoring in equipment qualification workflows

From Weeks to Minutes: How Intelligent Automation Transforms CQV Workflows

Discover how intelligent automation transforms CQV workflows and streamlines equipment qualification in pharma—cutting costs, time, and risk.

Split-screen showing manual vs. AI-enabled validation. Left: worker with spreadsheets and paper stacks. Right: same worker viewing clean data dashboards.

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.

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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 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

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

Risk-Based Cleaning Validation: A Lifecycle Approach to Compliance and Efficiency

Why Cleaning Validation Still Tops FDA 483 Observations

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

Validating Pharma 4.0 for Smart Manufacturing

The X Factor for Successful Digital Transformation in BioPharma: People

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