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
How Spreadsheets Create Compliance Risks: An Auditor's Perspective
May 18, 2023 11:00:00 AM | Spreadsheet tools like Excel raise a regulatory red flag and can trigger an audit. Your best defense is a validation lifecycle management system (VLMS).
Posts about Regulatory Compliance:
How Spreadsheets Create Compliance Risks: An Auditor's Perspective
Spreadsheet tools like Excel raise a regulatory red flag and can trigger an audit. Your best defense is a validation lifecycle management system (VLMS).
Business Continuity and Disaster Recovery in FDA-Regulated Industries
Digitization is the process of converting text, pictures (including video), and sound into a digital form that can be processed by computer technology.
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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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