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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Build an Effective Data Integrity Program with Risk Management
Dec 21, 2023 10:00:00 AM | Understand why data integrity problems occur, and learn how to build an effective, risk-based corporate data integrity program to address them.
Build an Effective Data Integrity Program with Risk Management
Understand why data integrity problems occur, and learn how to build an effective, risk-based corporate data integrity program to address them.
Using Digital Twins to Modernize Equipment Qualification
Is digital twin technology the key to achieving compliant, efficient equipment qualification in the modern life sciences manufacturing industry?
6 Ways to Make Your Risk Management More Effective
Improve the efficacy of your risk management process with these 6 strategies inspired by the ICH Q9 quality risk management guideline.
ICH Q12 Implementation: Enhancing PACM Agility
Explore the key aspects of ICH Q12 and a 5-step structured framework for effective post-approval change management (PACM) agility.
Types of Validation in the Pharmaceutical Industry
All systems, equipment, and processes that have GxP impact require validation. Here are the different types of validation in the pharmaceutical industry.
Six Best Practices for Alcoa Data Integrity
Learn about the significance of ALCOA+ in maintaining data integrity in the pharma industry and best practices for implementing ALCOA+ principles.
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.
FDA Warning Letters Expose the Risks of Using Paper Logbooks
Examples from real FDA warning letters show the risks and consequences of using paper logbooks and why a digital logbook management solution is essential.
What Is Paperless Validation All About?
In this post, we'll explore the transition to paperless validation and the benefits it brings such as efficiency, cost reduction, and compliance assurance.
How Can You Simplify Regulatory Approval for PAC?
Learn how to simplify regulatory approval for post-approval changes and discover the benefits of implementing a PACM protocol and using a QRM platform.
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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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