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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

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

Feb 20, 2025 9:00:00 AM | Discover how MilliporeSigma achieved rapid digital validation implementation with ValGenesis VLMS, transforming efficiency and compliance in just 97 days.

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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.

Comparison of manual spreadsheets vs. an automated requirements traceability matrix in ValGenesis VLMS

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.

Cloud-based computer system validation (CSV) illustrated with icons of data analytics and pharma elements, representing ValGenesis VLMS platform for life sciences

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.

Hands pointing to digital tools advocating for the transition from CSV to CSA

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.

A person interacting with a digital interface showing

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.

An illustration of a faceless figure holding a yellow

Avoid FDA 483 Observations with Digital Logbook Precision

Minimize FDA 483 observations and boost compliance with digital logbooks. Transform your documentation processes and reduce risk with ValGenesis e-Logbook.

Illustration of a person drawing a bow and aiming an arrow labeled 'Agile Validation' at a circular diagram representing the software development lifecycle (SDLC)

Agile vs. Waterfall: Validation in the Life Sciences Industry

Discover how Agile methodologies can enhance validation processes in the life sciences, ensuring compliance, flexibility, and faster time to market.

A person reviews software validation documentation on a tablet, highlighting the shift from CSV to CSA.

Leveraging Vendor Testing: A Smarter Approach to Validation

Learn how to reduce costs, improve accuracy, and enhance compliance by integrating vendor-provided testing into your validation framework.

Sampling sites on a piece of equipment for cleaning validation

Equipment Design in Cleaning Validation: Enhancing Your Sampling Plan

Discover the importance of equipment design in cleaning validation and how ValGenesis Process Manager improves sampling plans and ensures compliance.

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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

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.

Previously

Equipment Design in Cleaning Validation: Enhancing Your Sampling Plan

How Can Digital Cleaning Validation Improve Product Changeover Safety?

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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