Blog

Welcome to the ValGenesis blog, your resource for timely insights from industry-leading experts on the trends, best practices, and new technologies impacting the life sciences.

Latest News

6 Ts to Drive Computer Software Assurance Adoption

Feb 1, 2024 10:00:00 AM | Explore what's needed to successfully adopt the FDA's computer software assurance (CSA) guidance in your life sciences company.

Posts about Computer Software Assurance (CSA):

6 Ts to Drive Computer Software Assurance Adoption

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

Risk-based CSA Validation: Ensuring the Least Burdensome Approach

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

Embracing Change: The Transition from CSV to CSA in Pharmaceuticals

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

Saving Time and Resources with 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.

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.

FDAs Computer Software Assurance (CSA) – Part 3 of 3

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.

User Requirements Specification: Creating one for CSA

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

Computer Systems Assurance (CSA): What are Assurance Needs?

Computer Systems Assurance CSA prioritizes assurance needs after critical thinking. Here's what you need to address during this crucial part of the methodology.

How Can CSA Simplify Your Validation Processes

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

How Computer Software Assurance Will Impact Traditional CSV Testing

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

Featured Content

Finding the Root Cause in mAB Production: a ValGenesis Story

Root-Cause Analysis

Finding the Root Cause in mAB Production: a ValGenesis Story

Learn how we helped a customer find the root cause of a problem in monoclonal antibody (mAB) production and become stronger.

Sofia Santos

Written by
Sofia Santos

How to Accelerate Process Scale-Up With Effective Tech Transfer

Process Digitalization

How to Accelerate Process Scale-Up With Effective Tech Transfer

There's a need to accelerate pharma product development and process scale-up. Having an effective tech transfer strategy can help you.

Sofia Santos

Written by
Sofia Santos

Risk and Data as Knowledge Enablers: A Lifecycle Approach

Quality Risk Management

Risk and Data as Knowledge Enablers: a Lifecycle Approach - ValGenesis

Read the industry insight on the topic of Quality Risk Management

Sandra Silva

Presented by
Sandra Silva

Trending Topics With ValGenesis Customers

CSV and the Shift to CSA

CSA flips the paradigm of traditional CSV to "right-size" validation processes. Learn more about the benefits and principles of the CSA approach, which encourages critical thinking and automation.

Previously

CRO AmplifyBio Accelerates Trial Success with Digital CSV

Risk-based CSA Validation: Ensuring the Least Burdensome Approach

Cleaning Validation

Learn how digitization offers a consistent way to carry out cleaning validation lifecycle activities, ensuring your methods and procedures are risk-based and rooted in scientific evidence.

Previously

Game-Changing Tech Paves Way for Better Cleaning Validation Outcomes

Maximize the Use of Technology to Access Real-Time Clean In Place Data

Pharma 4.0

Waves of new technology and thinking — IoT, AR, cloud, Agile — are transforming the very foundation of validation processes. Learn how to leverage them in a Pharma 4.0 world.

Previously

The Pharma 4.0 Vision for Manufacturing Intelligence

High-quality Content Straight to Your Inbox!

Join our newsletter to receive updates on the latest news and industry-related content tailored to your preferences. 

newsletter