CSV vs. CSA: Choosing the Right Path for Software Validation
Learn about choosing between CSV and CSA for software validation. Understand the differences, benefits, and when to apply each method effectively.
Latest News
6 Ts to Drive Computer Software Assurance Adoption
Feb 1, 2024 10:00:00 AM | Explore what's needed to successfully adopt the FDA's computer software assurance (CSA) guidance in your life sciences company.
6 Ts to Drive Computer Software Assurance Adoption
Explore what's needed to successfully adopt the FDA's computer software assurance (CSA) guidance in your life sciences company.
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.
Digital Quality Risk Management: A ValGenesis Story
Learn about ValGenesis iRisk, an advanced tool for digital quality risk management, and its impact on vaccine development at a top biopharma company.
Best Practices for Process Validation in the Pharmaceutical Industry
Learn best practices for process validation in the pharma industry. Find out how digitalization streamlines validation operations and improves product quality.
CRO AmplifyBio Accelerates Trial Success with Digital CSV
Contract research organization (CRO) AmplifyBio leverages digital CSV capabilities to expedite trial success and gain a competitive edge. Read case study.
Five Cleaning Validation Challenges Digitalization Solves
This post examines five cleaning validation challenges that can be eliminated by digitizing your cleaning validation approach with ValGenesis.
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.
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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.
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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.
Five Cleaning Validation Challenges Digitalization Solves
This post examines five cleaning validation challenges that can be eliminated by digitizing your cleaning validation approach with ValGenesis.
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Game-Changing Tech Paves Way for Better Cleaning Validation Outcomes
Maximize the Use of Technology to Access Real-Time Clean In Place Data
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.
The X Factor for Successful Digital Transformation in BioPharma: People
This current era of biopharmaceutical manufacturing is a most challenging and exciting time for our industry. Technology breakthroughs, intensifying competition, and continually rising ...
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