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.
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How can CSA Simplify Your Validation Processes
Apr 12, 2023 11:11:26 AM | 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 can CSA Simplify Your Validation Processes
Recently, the FDA issued the draft of a new guidance for...
Developing a Retrospective QbD: a ValGenesis Story
Who doesn’t like a good story? Well, we have another for...
Types of Validation Processes in the Life Science Industry
Validation is a global regulatory requirement for the life...
How Computer Software Assurance Will Impact Traditional CSV Testing
This is the fourth post in a series of five summarizing a...
Removing Subjectivity in Risk Assessments
Subjectivity in Risk Assessments and Quality Risk...
Computer Software Assurance (CSA): What's All the Hype?
It seems like everyone is talking about computer software...
Challenges on Comparability Studies on Early Development Stages
During biopharma process development, there are often...
Risk Management for Medical Devices
Leveraging Technology to Address the ALARP vs AFAP Challenge
Q&A About Compliant, AR-Driven Hands-Free Validation
Q: What is Hands-Free Validation?
A: Hands-free...
New ICH Q14 Guideline: key Implementation Aspects
The International Council for Harmonisation (ICH) released...
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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.
Written by
Sofia Santos
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.
Written by
Sofia Santos
Quality Risk Management
Risk and Data as Knowledge Enablers: a Lifecycle Approach - ValGenesis
Read the industry insight on the topic of Quality Risk Management
Presented by
Sandra Silva
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.
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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.
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.
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Maximize the Use of Technology to Access Real-Time Clean In Place Data
Cleaning Validation Stage 1: On a Quest for Process Understanding
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.
The X Factor for Successful Digital Transformation in BioPharma: People
This current era of biopharmaceutical manufacturing is a most challenging and exciting time for our industry. Technology breakthroughs, intensifying competition, and continually rising ...
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