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.
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.
Sep 29, 2025 8:00:02 AM | ValConnect Innovation Day Princeton brought Bayer, GSK, Cardinal Health, Transcat & Hansa Biopharma together to explore AI & Smart GxP™ in life sciences.
ValConnect Innovation Day Princeton brought Bayer, GSK, Cardinal Health, Transcat & Hansa Biopharma together to explore AI & Smart GxP™ in life sciences.
If you’re following these 3 core principles, odds are you’re already aligned with the FDA's computer software assurance (CSA) methodology.
Learn how to reduce costs, improve accuracy, and enhance compliance by integrating vendor-provided testing into your validation framework.
Simplify your transition to computer software assurance (CSA) with ValGenesis iVal. Discover key features that streamline your validation processes.
Discover how ValGenesis VLMS optimizes validation with requirement-level risk assessment to enhance efficiency, compliance, and product quality.
Learn how traditional CSV conflicts with Agile development principles and why computer software assurance (CSA) is a better fit for Agile environments.
As life sciences companies work to ensure the quality and safety of their software systems, it's essential to understand the true intentions and uses of CSA.
Explore the benefits of computer software assurance for software validation in life sciences. Learn how digital tools address common fears of CSA adoption.
Learn how ISPE's GAMP 5 Guideline and the FDA's CSA Guidance play complementary roles in ensuring the integrity and reliability of computerized systems.
Explore what's needed to successfully adopt the FDA's computer software assurance (CSA) guidance in your life sciences company.
The post summarizes the key principles of CSA, various testing methodologies, risk management, and the benefits of digital software validation tools.
Unlocking the potential of Computer System Assurance (CSA) in pharmaceuticals: A roadmap for a seamless transition from CSV to CSA.
In this blog post, we will explore how making your transition from the traditional CSV to the new CSA approach can save you time and resources.
Is CSA the new CSV? Not exactly. Here's your comprehensive guide to computer software assurance, the FDA's new framework for validating software systems.
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.
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.
Written by
Sofia Santos
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.
Written by
Sofia Santos
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.
Written by
Kenneth Pierce
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.
ValConnect Innovation Day Princeton brought Bayer, GSK, Cardinal Health, Transcat & Hansa Biopharma together to explore AI & Smart GxP™ in life sciences.
Previously
The Benefits of Automating Your Requirements Traceability Matrix
Catalent's Journey of Continuous Improvement for CSV Excellence
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.
Discover why manual cleaning validation increases regulatory risk and how digital solutions can enhance data integrity and compliance in pharma operations.
Previously
Digital Cleaning Validation: From Lifecycle Control to Real-Time Assurance
Risk-Based Cleaning Validation: A Lifecycle Approach to Compliance and Efficiency
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.
Learn how Catalent scaled CSV compliance with ValGenesis VLMS to enhance global IT operations.
Previously
Validating Pharma 4.0 for Smart Manufacturing
The X Factor for Successful Digital Transformation in BioPharma: People
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