ValConnect Innovation Day Princeton: A Glimpse into the Digital Future of Life Sciences
ValConnect Innovation Day Princeton brought Bayer, GSK, Cardinal Health, Transcat & Hansa Biopharma together to explore AI & Smart GxP™ in life sciences.
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.
Apr 20, 2023 9:52:54 AM | This post examines the crucial impact quality culture has on individuals, organizations, and processes; it offers tips for improving it in your company.
This post examines the crucial impact quality culture has on individuals, organizations, and processes; it offers tips for improving it in your company.
This post is about tips to write your User Requirements Specification and how it can improve your processed data and software.
This time we tell you how we helped a company finding a root-cause in a Filter Clogging and how we solved it.
In this blog post we explore the topic of minimising the subjectivity in Risk Assessments through Digitalisation of processes.
Many medical device companies have struggled with implementing a risk management process that results in risk being mitigated to the level of AFAP.
The upcoming transition from CSV to CSA models reduces the cost of validation and provides a more risk and science based approach.
Learn how we helped a customer find the root cause of a problem in monoclonal antibody (mAB) production and become stronger.
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.
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.
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.
Assuring business continuity in pharma can be complex. Effective risk management strategies can help you operate during disruptions.
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.
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.
ValConnect Innovation Day Princeton brought Bayer, GSK, Cardinal Health, Transcat & Hansa Biopharma together to explore AI & Smart GxP™ in life sciences.
Previously
Catalent's Journey of Continuous Improvement for CSV Excellence
4 Conversations to Drive Your Business Case for Digital 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.
Discover how ValGenesis iClean™ standardizes change impact assessments in cleaning validation, enhancing consistency and compliance across teams and sites.
Previously
Unlocking Operational Capacity with Fully Digitalized Cleaning Validation
The Real Cost of Bottlenecks: Why Manual Cleaning Validation Increases Regulatory Risks
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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