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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Comparability for Post-Approval Changes
Apr 20, 2023 9:52:47 AM | Today we want to take a fresh look into comparability for post-approval changes. How? We're thinking of a unique multiparametric approach.
Comparability for Post-Approval Changes
Today we want to take a fresh look into comparability for...
Finding a Root-cause in a Filter Clogging at Drug Product Filtration
This ValGenesis story is about how we helped a company...
Cleaning Validation Stage 1: On a Quest for Process Understanding
The key to control for any process resides in understanding...
Bioequivalence Studies: how to Streamline Generic Drug Approval Process
Generic products can be safe, effective, and lower cost...
Manual CPV vs Digital CPV: Why Should you Upgrade?
In our last blog posts about Continued Process Verification...
Computer Software Assurance (CSA): What are Assurance Needs?
This is the third post in a series of five summarizing a...
ValConnect 2022 – Day Two Round-Up
Welcome to day two of ValConnect 2022! We’re halfway...
6 Reasons Validation Projects Fail
Life sciences companies are under increasing pressure to...
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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 ...
Previously
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