
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.
Welcome to the ValGenesis blog, your resource for timely insights from industry-leading experts on the trends, best practices, and new technologies impacting the life sciences.
Feb 8, 2024 10:00:00 AM | Learn about rising drug development costs, the role of CDMOs, and how a digital-first strategy can revolutionize tech transfer in the pharma industry.
Learn about rising drug development costs, the role of CDMOs, and how a digital-first strategy can revolutionize tech transfer in the pharma industry.
Explore what's needed to successfully adopt the FDA's computer software assurance (CSA) guidance in your life sciences company.
Learn about commissioning and qualification in pharma. Understand the processes involved and the regulatory guidelines to ensure product quality and safety.
Learn about ValGenesis iRisk, an advanced tool for digital quality risk management, and its impact on vaccine development at a top biopharma company.
Learn best practices for process validation in the pharma industry. Find out how digitalization streamlines validation operations and improves product quality.
This post examines five cleaning validation challenges that can be eliminated by digitizing your cleaning validation approach with ValGenesis.
Understand why data integrity problems occur, and learn how to build an effective, risk-based corporate data integrity program to address them.
Is digital twin technology the key to achieving compliant, efficient equipment qualification in the modern life sciences manufacturing industry?
Improve the efficacy of your risk management process with these 6 strategies inspired by the ICH Q9 quality risk management guideline.
Explore the key aspects of ICH Q12 and a 5-step structured framework for effective post-approval change management (PACM) agility.
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
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.
Automate your requirements traceability matrix to improve efficiency, reduce compliance risks, and streamline validation for better audit readiness.
Previously
Catalent's Journey of Continuous Improvement for CSV Excellence
Are You Aligned with FDA's Computer Software Assurance Methodology?
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.
Learn why cleaning validation in pharma is under regulatory scrutiny and how replacing manual processes with digital tools strengthens compliance.
Previously
Why Established Pharma Sites Need a Digital Cleaning Validation Strategy
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.
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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