Blog

This a story about how we helped a company with their biosimilarity assessments and to avoid massive time-to-market delay!

ValGenesis validation lifecycle management systems provide a solution that eliminates all the inefficiencies that plagued paper-based cleaning validation processes.

This post is about tips to write your User Requirements Specification and how it can improve your processed data and software.

Pharma has embraced digitization in many business lines, but validation has been one of the few processes to remain manual. Here are 12 reasons to make the switch! (Part 1 of 2)

Today we want to take a fresh look into comparability for post-approval changes. How? We're thinking of a unique multiparametric approach.

This time we tell you how we helped a company finding a root-cause in a Filter Clogging and how we solved it.  

Want to learn more about cleaning validation? The use of data collection, analysis, and evaluation are the most critical tasks in a cleaning validation program.

Explore the top 10 business benefits you'll receive from digitizing your paper-based validation processes with ValGenesis.

This blog post will give you an overview of bioequivalence studies and some strategies to streamline your generic drug approval process.

Discover how digital CPV enables real-time quality monitoring in pharma and supports continued process validation across the product lifecycle.

Understand the importance of assurance needs in the FDA’s Computer Software Assurance (CSA) approach and how to implement risk-based validation activities.

Many validation projects go over budget or fall behind schedule. Avoid these 6 common pitfalls to ensure your next project is a success.

A better resource use, a simpler process, and a superior product quality. These are some of the CSA benefits explored in this blog post.

A story about this time we helped a company in the Post-Approval Change Management of a Legacy Product using a Retrospective QbD methodology.

Computer software assurance (CSA) encourages the use of unscripted test methods, such as ad hoc testing, and automated technologies.