Blog

Learn about the requirements of the Annex 1 revision and how to ensure compliance with a digital risk management platform.

In this blog post, we will explore how making your transition from the traditional CSV to the new CSA approach can save you time and resources.

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.

Explore the three types of quality risk management (QRM) tools in pharma and learn how to assess, prioritize and control risk across the product lifecycle.

Learn how to write clear, defensible requirements and use Agile methodology and structured qualifiers to strengthen traceability in CSV and CSA.

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.

This blog post will give you an overview of Analytical QbD and why it's important to implement it in your method development.

The efficiencies gained, according to ValGenesis customers, range from 50% to 80% improvements. This lessens demand and allows more time to be focused on higher priority tasks. Knowing the ValGenesis VLMS ensures controls and standards are followed, according to customer-specific requirements, stakeholders are given a high-degree of assurance that Quality is ingrained in the process.

How to connect already existing AQbD with the new ICH Q14? Jean-François Dierick and Claudia Magagnoli from GSK explained us how!