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ValConnect Innovation Day Princeton brought Bayer, GSK, Cardinal Health, Transcat & Hansa Biopharma together to explore AI & Smart GxP™ in life sciences.

If you’re following these 3 core principles, odds are you’re already aligned with the FDA's computer software assurance (CSA) methodology.

Simplify your transition to computer software assurance (CSA) with ValGenesis iVal. Discover key features that streamline your validation processes.

Discover how ValGenesis VLMS optimizes validation with requirement-level risk assessment to enhance efficiency, compliance, and product quality.

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

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.

Explore the benefits of computer software assurance for software validation in life sciences. Learn how digital tools address common fears of CSA adoption.

Learn how ISPE's GAMP 5 Guideline and the FDA's CSA Guidance play complementary roles in ensuring the integrity and reliability of computerized systems.

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

The post summarizes the key principles of CSA, various testing methodologies, risk management, and the benefits of digital software validation tools.

Unlocking the potential of Computer System Assurance (CSA) in pharmaceuticals: A roadmap for a seamless transition from CSV to CSA.

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.

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.

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

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