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.
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Top 10 Benefits of ValGenesis Paperless Validation
Apr 20, 2023 9:52:43 AM | Explore the top 10 business benefits you'll receive from digitizing your paper-based validation processes with ValGenesis.
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.
Computer Systems Assurance (CSA): What are Assurance Needs?
Computer Systems Assurance CSA prioritizes assurance needs after critical thinking. Here's what you need to address during this crucial part of the methodology.
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.
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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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
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.
Previously
Catalent's Journey of Continuous Improvement for CSV Excellence
Are You Aligned with FDA's Computer Software Assurance Methodology?
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.
Why Established Pharma Sites Need a Digital Cleaning Validation Strategy
Discover how digital cleaning validation strategies can modernize established pharma facilities, ensuring compliance, efficiency, and patient safety.
Previously
Is Your Cleaning Validation Stuck in the Slow Lane?
Cleaning Validation Program Compliance: Build a Framework for Success
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.
Catalent's Journey of Continuous Improvement for CSV Excellence
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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