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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Twelve Reasons to Transition to a Digital Validation Process, Part 1
Apr 20, 2023 9:52:48 AM | 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)
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?
In this blog post you'll know the differences between Manual CPV vs Digital CPV and how we can help you on its implementation.
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!
All Tags
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.
Cleaning Validation Program Compliance: Build a Framework for Success
Streamline operations and ensure compliance with a digital cleaning validation framework. Discover strategies to enhance efficiency and tackle challenges.
Previously
Equipment Design in Cleaning Validation: Enhancing Your Sampling Plan
How Can Digital Cleaning Validation Improve Product Changeover Safety?
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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