CSV and CSA FAQs: Practical Answers for Life Sciences Validation Teams
Get practical answers about CSV, CSA, risk-based testing, assurance needs, documentation, requirements, and ValGenesis support for software validation.
Welcome to the ValGenesis blog, your resource for timely insights from industry-leading experts on the trends, best practices, and new technologies impacting the life sciences.
Mar 22, 2023, 12:00:45 PM | Cloud-based digital validation allows you to recover in the event of a disaster, ensuring business continuity and compliance.
Cloud-based digital validation allows you to recover in the event of a disaster, ensuring business continuity and compliance.
An important, and sometimes challenging, step in every product lifecycle is the point when it gets its premarket or a postmarket regulatory approval by the FDA. Luckily, through a combination of good practices for Benefit-Risk Assessment and technology, this has become much easier.
In this blog post, we’ll go through some concepts on Knowledge Management and the starting points for its implementation.
Unlock the potential of IoT in validation and manufacturing to enhance efficiency, reduce costs, and improve product quality across pharmaceutical operations.
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.
This story is about our project with Libbs Farmacêutica to successfully apply a QbD framework in the development of an oral drug product
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.
In this blog post, we'll give you some tips that help you setting up a Digital CPV plan in only three steps.
In this blog post, we show you how digital validation can improve your validation process and enhance your business efficiency.
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.
Learn how Process Analytical Technology (PAT) enhances continuous manufacturing in pharma, improving process control, product quality, and operational efficiency.
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.
The new ICH Q14 guideline is here! How to implement it? We talked with Jean-François Dierick and Claudia Magagnoli on how they did it at GSK.
Assuring business continuity in pharma can be complex. Effective risk management strategies can help you operate during disruptions.
Using QRM within a Lifecycle Management framework ensures consistency at all levels where modern pharma operations are concerned.
Quality Risk Management
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
Tech Transfer & Process Scale-up
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
Cleaning Validation
Risk-Based Cleaning Validation: A Lifecycle Approach
Explore the evolution of pharmaceutical cleaning validation from compliance-focused practices to a risk-based, lifecycle-driven approach.
Written by
Kenneth Pierce
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.
Get practical answers about CSV, CSA, risk-based testing, assurance needs, documentation, requirements, and ValGenesis support for software validation.
Previously
ValConnect Innovation Day Princeton: A Glimpse into the Digital Future of Life Sciences
Catalent's Journey of Continuous Improvement for CSV Excellence
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.
Explore practical FAQs on cleaning validation in pharma, including regulatory expectations, limits, lifecycle stages, sampling, change control, and digital execution.
Previously
Dirty and Clean Hold Times: Setting Defensible Limits for Cleaning Validation
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.
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