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 10:27:57 AM | The efficiencies gained, according to ValGenesis customers, range from 50% to 80% improvements. This lessens demand and allows more time to be focused on higher priority tasks. Knowing the ValGenesis VLMS ensures controls and standards are followed, according to customer-specific requirements, stakeholders are given a high-degree of assurance that Quality is ingrained in the process.
The efficiencies gained, according to ValGenesis customers, range from 50% to 80% improvements. This lessens demand and allows more time to be focused on higher priority tasks. Knowing the ValGenesis VLMS ensures controls and standards are followed, according to customer-specific requirements, stakeholders are given a high-degree of assurance that Quality is ingrained in the process.
How to connect already existing AQbD with the new ICH Q14? Jean-François Dierick and Claudia Magagnoli from GSK explained us how!
Paper-based workflows have been the industry standard for validating systems and processes. But companies gain many benefits from going digital. (Part 2 of 2)
This post examines the crucial impact quality culture has on individuals, organizations, and processes; it offers tips for improving it in your company.
If you think of validation as a pie, document authoring is 25% of the pie. A DMS can’t address the other 75% of validation activities ValGenesis supports.
ValGenesis (VLMS) has capitalized on delivering functionality to support object-oriented validation. Here you can create requirements as objects, and these can be shared.
An efficient control strategy will ensure your processes performs always as expected. In this blog post we described the steps to design one.
This a story about how we helped a company with their biosimilarity assessments and to avoid massive time-to-market delay!
ValGenesis validation lifecycle management systems provide a solution that eliminates all the inefficiencies that plagued paper-based cleaning validation processes.
This post is about tips to write your User Requirements Specification and how it can improve your processed data and software.
Pharma has embraced digitization in many business lines, but validation has been one of the few processes to remain manual. Here are 12 reasons to make the switch! (Part 1 of 2)
Today we want to take a fresh look into comparability for post-approval changes. How? We're thinking of a unique multiparametric approach.
This time we tell you how we helped a company finding a root-cause in a Filter Clogging and how we solved it.
Want to learn more about cleaning validation? The use of data collection, analysis, and evaluation are the most critical tasks in a cleaning validation program.
Explore the top 10 business benefits you'll receive from digitizing your paper-based validation processes with ValGenesis.
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
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.
Explore the complexities of cleaning validation limits, including HBEL/MACO, 10 ppm, and visually clean to ensure patient safety and product quality.
Previously
Change Impact Assessments in ValGenesis iClean™: A Framework for Consistency
Unlocking Operational Capacity with Fully Digitalized 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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