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
Why Manual CQV Costs More Than You Think
Apr 11, 2025 12:50:40 PM | Discover the hidden costs of manual CQV. Learn how AI-enabled digital CQV can enhance efficiency, compliance, and innovation in pharma manufacturing.
Posts about Commissioning, Qualification Validation (CQV):
Why Manual CQV Costs More Than You Think
Discover the hidden costs of manual CQV. Learn how AI-enabled digital CQV can enhance efficiency, compliance, and innovation in pharma manufacturing.
Move Beyond Manual CQV Challenges with Digital Solutions
Discover how digital CQV with ValGenesis VLMS streamlines compliance, cuts costs, and boosts efficiency, supported by customer metrics that demonstrate measurable ROI.
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.
Best Practices in Commissioning and Qualification ― Part Two
Discover best practices for integrating your commissioning and qualification processes and how to streamline C&Q activities with robust digital solutions.
Best Practices in Commissioning and Qualification ― Part One
Learn best practices for implementing an integrated commissioning and qualification approach and the 5 critical elements to include in your C&Q plan.
Commissioning and Qualification in Pharma: An Overview
Learn about commissioning and qualification in pharma. Understand the processes involved and the regulatory guidelines to ensure product quality and safety.
Commissioning and Qualification in the Life Sciences
Traditional commissioning and qualification can be very challenging due to the inefficiencies, compliance risk, lack of data integration, inability to adequately track and close out activities.
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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.
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.
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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