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.
Latest News
Is Your Cleaning Validation Stuck in the Slow Lane?
May 22, 2025 10:15:00 AM | Discover what cleaning validation is in pharma, why it's required, and how digital tools help you meet FDA cleaning validation guidelines efficiently.
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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.
How Spreadsheet Chaos Derails Quality by Design in Pharma
Learn how spreadsheet chaos undermines Quality by Design in pharma—and how digital QbD platforms support CMC manufacturing and development.
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.
Why Manual CQV Costs More Than You Think
Discover the hidden costs of manual CQV. Learn how AI-enabled digital CQV can enhance efficiency, compliance, and innovation in pharma manufacturing.
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.
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.
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.
Are You Aligned with FDA's Computer Software Assurance Methodology?
If you’re following these 3 core principles, odds are you’re already aligned with the FDA's computer software assurance (CSA) methodology.
Cleaning Validation Program Compliance: Build a Framework for Success
Streamline operations and ensure compliance with a digital cleaning validation framework. Discover strategies to enhance efficiency and tackle challenges.
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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
Quality Risk Management
Risk and Data as Knowledge Enablers: a Lifecycle Approach - ValGenesis
Read the industry insight on the topic of Quality Risk Management
Presented by
Sandra Silva
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
Catalent's Journey of Continuous Improvement for CSV Excellence
Are You Aligned with FDA's Computer Software Assurance Methodology?
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.
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.
Previously
Cleaning Validation Program Compliance: Build a Framework for Success
Equipment Design in Cleaning Validation: Enhancing Your Sampling Plan
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.
Catalent's Journey of Continuous Improvement for CSV Excellence
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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