What's Stopping You? Overcoming CSA Adoption Concerns
Explore the benefits of computer software assurance for software validation in life sciences. Learn how digital tools address common fears of CSA adoption.
Latest News
The Business and Buzz of IoT in Validation
Mar 22, 2023 12:00:39 PM | The Internet of Things (IoT), sometimes described as an interconnected enterprise system, creates quite the buzz in business circles today. Connecting data, information, and knowledge certainly carries the potential power of creating intelligence to leap ahead of the competition.
The Business and Buzz of IoT in Validation
The Internet of Things (IoT), sometimes described as an interconnected enterprise system, creates quite the buzz in business circles today. Connecting data, information, and knowledge certainly carries the potential power of creating intelligence to leap ahead of the competition.
4 Conversations to Drive Your Business Case for Digital Validation
Use these 4 conversation starters to overcome the common hurdles to digital validation and make a compelling case for transitioning to a paperless system.
Risk Management and Process Optimization: a ValGenesis story
A light story about how ValGenesis joining on a quest to optimize a stage in a process, how did we do it and what came out of it.
Developing a Drug Product Using QbD: a ValGenesis Story
This story is about our project with Libbs Farmacêutica to successfully apply a QbD framework in the development of an oral drug product
Creating a Post-approval Change Management (PACM) Protocol
In this blog post, we will give you all the steps about how to create a PACM protocol and how ICH Q12 supports you in it.
How to Set up a Digital CPV Plan in 3 Steps
In this blog post, we'll give you some tips that help you setting up a Digital CPV plan in only three steps.
How to Improve Business Efficiency With Digital Validation
In this blog post, we show you how digital validation can improve your validation process and enhance your business efficiency.
GMP Annex 1 Revision + QRM Digitalization: a Perfect Match
The EU has released its GMP Annex 1 revision after 14 years of development! This blog post gives a few ideas on how to apply it more easily.
Process Analytical Technology in Continuous Manufacturing
If you are looking to reap the full benefits of Continuous Manufacturing, this a post is about how to use PAT for advanced analytics applications.
Cell and Gene Therapies: Risk Management Processes
In this blog post, we talk about how can you implement Risk Management Processes for Cell and Gene Therapies to every aspect of your product.
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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.
Best Practices for Impact Assessments in Cleaning Validation
Explore best practices for impact assessments in cleaning validation, including strategies for using technology to streamline the assessment process.
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.
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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