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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

Saving Time and Resources with CSA

Jun 29, 2023 10:00:00 AM | 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.

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.

Decentralized Clinical Trials: Why Digitization is a Must

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

It's Time to Implement ICH Q9(R1)

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.

Enhancing Continuous Manufacturing with Digital CPV Integration

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

How Spreadsheets Create Compliance Risks: An Auditor's Perspective

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

Game-Changing Tech Paves Way for Better Cleaning Validation Outcomes

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

The 3 Types of Quality Risk Management Tools and What They Do Best

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.

Requirements Management 101: Tips for Writing Good Requirements

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

Cell & Gene Therapies: is Quality by Design Ready for it?

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?

Finding the Root-Cause in a Process: a ValGenesis Story

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.

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

6 Ts to Drive Computer Software Assurance Adoption

CRO AmplifyBio Accelerates Trial Success with Digital CSV

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

Five Cleaning Validation Challenges Digitalization Solves

Game-Changing Tech Paves Way for Better Cleaning Validation Outcomes

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

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