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.
Blog
Blog
_________________
Latest News
ValConnect 2022 – Day One Round-Up
Apr 12, 2023 11:11:12 AM | ValConnect 2022 is off to a great start! Today's agenda featured live product demos and a keynote from Roche/Genentech. Here's a recap of day one.
ValConnect 2022 – Day One Round-Up
Welcome to day one of ValConnect 2022! We’re off to a great...
Commissioning and Qualification Validation in the Life Sciences Industry
Commissioning and Qualification is a critical regulatory...
Transitioning From CSV to CSA
Changes are challenging, and in the digital world what we...
The X Factor for Successful Digital Transformation in BioPharma: People
Digital transformation isn’t all about technology. To...
4 Life Sciences Lessons from the PAT to QbD Journey
During and after the COVID-19 pandemic, prevailing chaos in...
Cleaning Validation Stage 2: Performance Qualification
The second stage of the validation lifecycle is called...
Cleaning Validation Pain Points & How to Solve Them Through Digitization
Product contamination due to insufficient cleaning...
FDA's Computer Software Assurance (CSA) – Part 1 of 3
This blog is the first of a three-part series focused on...
Finding the Root Cause in mAB Production: a ValGenesis Story
Learn how we helped a customer find the root cause of a...
Boost Efficiency with Digital Equipment Qualification and Validation
Equipment qualification and validation (EQ/V) has always...
All Tags
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.
Previously
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
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.
