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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Enhancing Continuous Manufacturing with Digital CPV Integration
Jun 1, 2023 10:39:52 AM | Learn how implementing digital CPV plans can contribute to continuous processes reaping the benefits of Industry 4.0 and digitalization.
All Blog Posts
Enhancing Continuous Manufacturing with Digital CPV Integration
Applying continued process verification (CPV) plans to...
How Spreadsheets Create Compliance Risks: An Auditor's Perspective
As an auditor, it raises a big red flag when I discover...
Game-Changing Tech Paves Way for Better Cleaning Validation Outcomes
Cleaning validation remains a significant concern during...
The 3 Types of Quality Risk Management Tools and What They Do Best
Quality risk management (QRM) is a crucial process for...
Requirements Management 101: Tips for Writing Good Requirements
Have you ever added the wrong ingredient to a recipe and...
Cell & Gene Therapies: is Quality by Design Ready for it?
In this blogpost, we will explore the application of...
Finding the Root-Cause in a Process: a ValGenesis Story
This is a happy story. But it’s also confidential in some...
Your Guide to Computer Software Assurance (CSA)
The upcoming draft guidance on computer software assurance...
Is Analytical QbD the Future of Method Development?
By now, we all know that Quality by Design (QbD)...
FDAs Computer Software Assurance (CSA) – Part 3 of 3
How ValGenesis VLMS fosters a Quality-Focused Culture
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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.
Previously
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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