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.
Latest News
How Can Digital Cleaning Validation Improve Product Changeover Safety?
Oct 17, 2024 10:00:00 AM | Learn how digital cleaning validation solutions can prevent cross-contamination and ensure drug safety during product changeovers in pharma manufacturing.
How Can Digital Cleaning Validation Improve Product Changeover Safety?
Learn how digital cleaning validation solutions can prevent cross-contamination and ensure drug safety during product changeovers in pharma manufacturing.
Out-of-the-Box Computer Software Assurance with ValGenesis
Simplify your transition to computer software assurance (CSA) with ValGenesis VLMS. Discover key features that streamline your validation processes.
Requirement-Level Risk Assessment: A Game-Changer in Validation
Discover how ValGenesis VLMS optimizes validation with requirement-level risk assessment to enhance efficiency, compliance, and product quality.
Mastering Equipment Hold Time Controls with Electronic Logbooks
Optimize pharma manufacturing with ValGenesis e-Logbook for automated clean/dirty hold time management. Ensure compliance, efficiency, and patient safety.
Save Time and Resources with Digital Continued Process Verification
Discover how digital CPV optimizes pharmaceutical manufacturing, reducing time, costs, and errors through real-time monitoring and automated processes.
Digitalizing Pharma Control Strategies: A Roadmap
Transform pharma manufacturing with digital control strategies. Learn how to enhance product quality, streamline processes, and ensure regulatory compliance.
Avoiding Common FDA 483 Observations in Cleaning Validation
Learn to avoid FDA 483 observations in cleaning validation to ensure patient safety and product efficacy. Protect your business with these actionable strategies.
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?
Learn why cleaning validation is important, what FDA and global guidelines require, and how a digital system can reduce risk and ensure GMP compliance.
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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.
Is Your Cleaning Validation Stuck in the Slow Lane?
Discover what cleaning validation is in pharma, why it's required, and how digital tools help you meet FDA cleaning validation guidelines efficiently.
Previously
Cleaning Validation Program Compliance: Build a Framework for Success
Equipment Design in Cleaning Validation: Enhancing Your Sampling Plan
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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