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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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The Benefits of Automating Your Requirements Traceability Matrix

Feb 13, 2025 2:45:00 PM | Automate your requirements traceability matrix to improve efficiency, reduce compliance risks, and streamline validation for better audit readiness.

Posts by Emmanuel Cansino:

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.

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.

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.

The image contrasts two figures: on the left, a person sweating while holding a large stack of paperwork and an hourglass, symbolizing a slow process. On the right, a person sits at a laptop, surrounded by icons like a light bulb, rocket, and gear with a checkmark, representing efficiency and agility.

Rethinking Validation: Why CSV Falls Short for Agile Teams

Learn how traditional CSV conflicts with Agile development principles and why computer software assurance (CSA) is a better fit for Agile environments.

Illustration representing computer software assurance (CSA) with icons showing testing, risk, and guidance comparison, including 2002 Guidance and CSA Guidance

Top 5 Misconceptions About Computer Software Assurance

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.

Excel spreadsheet with overlay screenshot of ValGenesis risk management platform

Let's Move Beyond Spreadsheets for Risk Management

Discover why Excel is no longer sufficient for effective risk management in the pharma industry and why transitioning to specialized software is crucial.

6 Ts to Drive Computer Software Assurance Adoption

Explore what's needed to successfully adopt the FDA's computer software assurance (CSA) guidance in your life sciences company.

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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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