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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.
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User Requirements Specification: Creating one for CSA
Apr 20, 2023 9:52:49 AM | This post is about tips to write your User Requirements Specification and how it can improve your processed data and software.
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User Requirements Specification: Creating one for CSA
This post is about tips to write your User Requirements Specification and how it can improve your processed data and software.
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Twelve Reasons to Transition to a Digital Validation Process, Part 1
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)
Comparability for Post-Approval Changes
Today we want to take a fresh look into comparability for post-approval changes. How? We're thinking of a unique multiparametric approach.
Finding a Root-cause in a Filter Clogging at Drug Product Filtration
This time we tell you how we helped a company finding a root-cause in a Filter Clogging and how we solved it.
Cleaning Validation Stage 1: On a Quest for Process Understanding
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.
Top 10 Benefits of ValGenesis Paperless Validation
Explore the top 10 business benefits you'll receive from digitizing your paper-based validation processes with ValGenesis.
Planning Is Well Underway for ValConnect 2022
ValGenesis' global user conference brings together customers, partners, experts and employees for an informative, inspiring and interactive experience.
Bioequivalence Studies: How to Streamline Generic Drug Approval Process
This blog post will give you an overview of bioequivalence studies and some strategies to streamline your generic drug approval process.
Manual CPV vs Digital CPV: Why Should You Upgrade?
Discover how digital CPV enables real-time quality monitoring in pharma and supports continued process validation across the product lifecycle.
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Computer Software Assurance (CSA): What Are Assurance Needs?
Understand the importance of assurance needs in the FDA’s Computer Software Assurance (CSA) approach and how to implement risk-based validation activities.
ValConnect 2022 – Day Two Round-Up
Day two of ValConnect 2022 featured a live demo of ValGenesis University and a keynote from FDA's Cisco Vicenty. Read the recap!
6 Reasons Validation Projects Fail
Many validation projects go over budget or fall behind schedule. Avoid these 6 common pitfalls to ensure your next project is a success.
How Can CSA Simplify Your Validation Processes
A better resource use, a simpler process, and a superior product quality. These are some of the CSA benefits explored in this blog post.
Developing a Retrospective QbD: a ValGenesis Story
A story about this time we helped a company in the Post-Approval Change Management of a Legacy Product using a Retrospective QbD methodology.
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How Computer Software Assurance Will Impact Traditional CSV Testing
Computer software assurance (CSA) encourages the use of unscripted test methods, such as ad hoc testing, and automated technologies.
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Featured Content
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
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
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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The Benefits of Automating Your Requirements Traceability Matrix
Catalent's Journey of Continuous Improvement for CSV Excellence
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.
Unlocking Operational Capacity with Fully Digitalized Cleaning Validation
Discover how fully digitalized cleaning validation boosts efficiency, ensures compliance, and transforms operational capacity in pharmaceutical manufacturing.
Previously
The Real Cost of Bottlenecks: Why Manual Cleaning Validation Increases Regulatory Risks
Digital Cleaning Validation: From Lifecycle Control to Real-Time Assurance
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.
Unlocking Operational Capacity with Fully Digitalized Cleaning Validation
Discover how fully digitalized cleaning validation boosts efficiency, ensures compliance, and transforms operational capacity in pharmaceutical manufacturing.
Previously
Catalent's Journey of Continuous Improvement for CSV Excellence
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