Leveraging Vendor Testing: A Smarter Approach to Validation
Learn how to reduce costs, improve accuracy, and enhance compliance by integrating vendor-provided testing into your validation framework.
Latest News
6 Ways to Make Your Risk Management More Effective
Dec 7, 2023 10:00:00 AM | Improve the efficacy of your risk management process with these 6 strategies inspired by the ICH Q9 quality risk management guideline.
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.
What Changes When Your CPV Goes Digital - A ValGenesis Story
Explore the essential role of CPV in your manufacturing process and discover the transformative impact of going digital in this blog post case study.
Generative AI and Its Impact on Validation: Part 2
This post is the second installment of a two-part series on the incredible impact of generative AI, particularly ChatGPT, on validation in the life sciences.
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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
Out-of-the-Box Computer Software Assurance with ValGenesis
Requirement-Level Risk Assessment: A Game-Changer in Validation
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.
Equipment Design in Cleaning Validation: Enhancing Your Sampling Plan
Discover the importance of equipment design in cleaning validation and how ValGenesis Process Manager improves sampling plans and ensures compliance.
Previously
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
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