Are You Aligned with FDA's Computer Software Assurance Methodology?
If you’re following these 3 core principles, odds are you’re already aligned with the FDA's computer software assurance (CSA) methodology.
Latest News
Rethinking Validation: Why CSV Falls Short for Agile Teams
Aug 29, 2024 10:00:00 AM | Learn how traditional CSV conflicts with Agile development principles and why computer software assurance (CSA) is a better fit for Agile environments.
Rethinking Validation: Why CSV Falls Short for Agile Teams
Learn how traditional CSV conflicts with Agile development principles and why computer software assurance (CSA) is a better fit for Agile environments.
A Toolbox for Effective Tech Transfer
Discover how digital tools simplify tech transfer in Pharma 4.0, enhancing efficiency, product quality, and speed to market in the pharmaceutical industry.
What are the Regulatory Expectations for Cleaning Validation?
Explore the regulatory expectations for cleaning validation, the challenges faced, and how ValGenesis Process Manager can help you simplify compliance.
Better Pharmaceutical Development: A Case for ValGenesis iRisk
See how ValGenesis iRisk transforms pharmaceutical development by integrating QbD and AQbD, streamlining processes, improving quality, and expediting approvals.
Top 5 Misconceptions About Computer Software Assurance
As life sciences companies work to ensure the quality and safety of their software systems, it's essential to understand the true intentions and uses of CSA.
Driving Success with Digital C&Q and Pharma 4.0
Learn about the benefits and impact of transitioning to digital C&Q solutions for enhanced efficiency, compliance, and innovation in a Pharma 4.0 world.
Avoiding the Pitfalls of PQRs with Digital Solutions
Learn to enhance Product Quality Reviews (PQRs) with digital solutions that drive quality improvement and regulatory compliance in pharma manufacturing.
NEXA | EAM Streamlines Equipment Qualification with ValGenesis VLMS
This case study highlights the transformative impact of VLMS technology to modernize equipment qualification processes and drive operational excellence at NEXA.
Should You Use QRM Software for ICH Q9 (R1) Compliance? Yes!
Learn why using quality risk management (QRM) software is crucial for ICH Q9 R1 compliance in the pharmaceutical industry.
ValConnect 2024: A Global Gathering in Lisbon
Discover the highlights from ValConnect 2024, showcasing cutting-edge technologies, customer success stories, and the unveiling of ValGenesis VLMS 5.0.
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
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.
Validating Pharma 4.0 for Smart Manufacturing
Explore how Pharma 4.0 leverages advanced technologies to revolutionize pharmaceutical manufacturing, enhancing efficiency, quality, and patient-centric outcomes.
Previously
The X Factor for Successful Digital Transformation in BioPharma: People
High-quality Content Straight to Your Inbox!
Join our newsletter to receive updates on the latest news and industry-related content tailored to your preferences.
