
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.
Jun 1, 2023 10:39:52 AM | Learn how implementing digital CPV plans can contribute to continuous processes reaping the benefits of Industry 4.0 and digitalization.
Learn how implementing digital CPV plans can contribute to continuous processes reaping the benefits of Industry 4.0 and digitalization.
Spreadsheet tools like Excel raise a regulatory red flag and can trigger an audit. Your best defense is a validation lifecycle management system (VLMS).
ValGenesis Process Manager can help life sciences companies avoid FDA 483s and establish a harmonized cleaning validation program companywide.
This post highlights the benefits and limitations of 3 types of QRM tools (simple brainstorming tools, simple risk analysis tools, and complex risk classification tools) and provides suggestions for their ideal application.
Writing good requirements during the requirements management process is the key to better product quality, accelerated development, and less rework.
In this blog post, we want to discuss about the application of the Quality by Design for Cell & Gene Therapies. Are they suited for them?
A light story about how ValGenesis joining on a quest to finding the root cause of a deviation in a process, how did we do it and what came of it.
Is CSA the new CSV? Not exactly. Here's your comprehensive guide to computer software assurance, the FDA's new framework for validating software systems.
This blog post will give you an overview of Analytical QbD and why it's important to implement it in your method development.
The efficiencies gained, according to ValGenesis customers, range from 50% to 80% improvements. This lessens demand and allows more time to be focused on higher priority tasks. Knowing the ValGenesis VLMS ensures controls and standards are followed, according to customer-specific requirements, stakeholders are given a high-degree of assurance that Quality is ingrained in the process.
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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