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
Avoiding Common FDA 483 Observations in Cleaning Validation
Sep 5, 2024 10:15:00 AM | Learn to avoid FDA 483 observations in cleaning validation to ensure patient safety and product efficacy. Protect your business with these actionable strategies.
Posts about Regulatory Requirements:
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.
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.
What is FDA 21 CFR Part 11 Compliance?
Learn about FDA 21 CFR Part 11 compliance and the regulatory requirements for electronic records and signatures in the life sciences industry.
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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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