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ValGenesis Blog

The ValGenesis blog is dedicated to the best practices, insights and trends in validation for the life sciences industry.

Featured Content

Digital Validation

Greenfield CDMO Theragent Sees Digitization as Key to Accelerating Innovation and Time to Market

Speed-to-market is a top priority for CDMOs. Being a digital-first organization gives Theragent a substantial competitive advantage.

Written by
Lisa Weeks

Computer Software Assurance (CSA)

Your Guide to Computer Software Assurance (CSA)

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.

Written by
Lisa Weeks

Quality by Design

Apply Quality by Design (QbD) for all Validation Types - QbD for All

Watch the event presentation on the topic of Quality by Design, originally presented at Validation & GMP University in 2021.

Presented by
Steve Thompson

Trending Topics with ValGenesis Customers

CSV and the Shift to CSA

CSA flips the paradigm of validation to ensure "right sizing" of validation processes. Start preparing now.


Your Guide to Computer Software Assurance (CSA)

Computer Software Assurance (CSA): Focus on Records, Not Documentation

How Computer Software Assurance Will Impact Traditional CSV Testing

Cleaning Validation

Embrace the new generation of technology to achieve compliant, digital documentation with full integration of validation data.


Cleaning Validation Stage 2: Performance Qualification

Cleaning Validation Stage 1: On a Quest for Process Understanding

Challenges with Traditional Cleaning Validation

Transforming to Paperless

The ROI of digitization is clear: gain time efficiency, cost savings and inspection-readiness when you shift to paperless validation.


“No Paper” is Only 25% of the Benefit of “Paperless” Validation

Business Continuity Plan (BCP) for Validation Program amid a Pandemic

Paperless 3 Stage Process Validation Lifecycle Approach

Pharma 4.0

Waves of new technology and thinking — IoT, AR, cloud, agile — are transforming the very foundation of validation processes.


The Pharma 4.0 Vision for Manufacturing Intelligence

How to Track Everything and Reveal Nothing: Promising Technologies to Accomplish the Impossible

Digitization of Validation for Effective Off-site Regulatory “Review” and “Inspection”