Blog

Sponsors and CROs are prioritizing digitization to build a foundation for decentralized clinical trials and using AI/ML tools to improve patient outcomes.

In this blog post we'll look into what steps you may need to take to make sure you are compliant with the ICH Q9(R1) guideline.

Learn how implementing digital CPV plans can contribute to continuous processes reaping the benefits of Industry 4.0 and digitalization.

Spreadsheet tools like Excel raise a regulatory red flag and can trigger an audit. Your best defense is a validation lifecycle management system (VLMS).

ValGenesis Process Manager can help life sciences companies avoid FDA 483s and establish a harmonized cleaning validation program companywide.

This post highlights the benefits and limitations of 3 types of QRM tools (simple brainstorming tools, simple risk analysis tools, and complex risk classification tools) and provides suggestions for their ideal application.

Writing good requirements during the requirements management process is the key to better product quality, accelerated development, and less rework.

In this blog post, we want to discuss about the application of the Quality by Design for Cell & Gene Therapies. Are they suited for them?

A light story about how ValGenesis joining on a quest to finding the root cause of a deviation in a process, how did we do it and what came of it.

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.