
The Benefits of Automating Your Requirements Traceability Matrix
Automate your requirements traceability matrix to improve efficiency, reduce compliance risks, and streamline validation for better audit readiness.
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 11:59:26 AM | Using QRM within a Lifecycle Management framework ensures consistency at all levels where modern pharma operations are concerned.
Using QRM within a Lifecycle Management framework ensures consistency at all levels where modern pharma operations are concerned.
Tech Transfer is especially important. When switching facilities, you want to transfer the knowledge and reproduce the process smoothly.
There are still some challenges when it comes to minimizing the risks in Cell and Gene Therapy. Here, we give some thoughts on how to manage and minimize them.
In this blog post, we tell what the most effective approach for your biosimilars approval to reduce its time to market is.
Continuous Manufacturing brings quality and delivery many business gains when applied to biologic products.
Cell and Gene Therapy products are considered the future of medicine. PAT and QbD can bring many benefits to C>
A blog post about applying digital transformation to the QRM of the top-tiers of the Pharmaceutical Companies and how it can benefit them.
This is a post about optimising a perfusion cell culture, using a combination of Root Cause Anlysis and Corrective and Preventive Action.
A blog post where we give you some tips on how Quality Risk Management can help you improve your Medical Cannabis business
ATMPs are a field that is new, complex, and specific. Having a digital QRM System for ATMPs can have a strong impact in your operations.
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
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.
Automate your requirements traceability matrix to improve efficiency, reduce compliance risks, and streamline validation for better audit readiness.
Previously
Catalent's Journey of Continuous Improvement for CSV Excellence
Are You Aligned with FDA's Computer Software Assurance Methodology?
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.
Learn why cleaning validation in pharma is under regulatory scrutiny and how replacing manual processes with digital tools strengthens compliance.
Previously
Why Established Pharma Sites Need a Digital Cleaning Validation Strategy
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.
Learn how Catalent scaled CSV compliance with ValGenesis VLMS to enhance global IT operations.
Previously
Validating Pharma 4.0 for Smart Manufacturing
The X Factor for Successful Digital Transformation in BioPharma: People
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