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.
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Leveraging Vendor Testing: A Smarter Approach to Validation
Dec 12, 2024 10:00:00 AM | Learn how to reduce costs, improve accuracy, and enhance compliance by integrating vendor-provided testing into your validation framework.
Posts about Computer System Validation (CSV):
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.
Rethinking Validation: Why CSV Falls Short for Agile Teams
Learn how traditional CSV conflicts with Agile development principles and why computer software assurance (CSA) is a better fit for Agile environments.
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.
Embracing Change: The Transition from CSV to CSA in Pharmaceuticals
Unlocking the potential of Computer System Assurance (CSA) in pharmaceuticals: A roadmap for a seamless transition from CSV to CSA.
How to Overcome the Subjectivity of Objective Evidence in FDA Audits
How do we deliver objective evidence with a high degree of certainty it will withstand regulatory scrutiny? Technology tools like a VLMS hold the answer.
Saving Time and Resources with CSA
In this blog post, we will explore how making your transition from the traditional CSV to the new CSA approach can save you time and resources.
Requirements Management 101: Tips for Writing Good Requirements
Writing good requirements during the requirements management process is the key to better product quality, accelerated development, and less rework.
How Can CSA Simplify Your Validation Processes
A better resource use, a simpler process, and a superior product quality. These are some of the CSA benefits explored in this blog post.
Computer Software Assurance (CSA): What's All the Hype?
Computer software validation (CSV) and computer software assurance (CSA) aren't all that different. So then, what's all the hype about? Let's discuss.
Transitioning From CSV to CSA
The upcoming transition from CSV to CSA models reduces the cost of validation and provides a more risk and science based approach.
All Tags
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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