Out-of-the-Box Computer Software Assurance with ValGenesis
Simplify your transition to computer software assurance (CSA) with ValGenesis VLMS. Discover key features that streamline your validation processes.
Latest News
It's Time to Implement ICH Q9(R1)
Jun 15, 2023 11:00:00 AM | In this blog post we'll look into what steps you may need to take to make sure you are compliant with the ICH Q9(R1) guideline.
Posts about Regulatory Affairs:
It's Time to Implement ICH Q9(R1)
In this blog post we'll look into what steps you may need to take to make sure you are compliant with the ICH Q9(R1) guideline.
Bioequivalence Studies: How to Streamline Generic Drug Approval Process
This blog post will give you an overview of bioequivalence studies and some strategies to streamline your generic drug approval process.
Removing Subjectivity in Risk Assessments
In this blog post we explore the topic of minimising the subjectivity in Risk Assessments through Digitalisation of processes.
Creating a Post-approval Change Management (PACM) Protocol
In this blog post, we will give you all the steps about how to create a PACM protocol and how ICH Q12 supports you in it.
GMP Annex 1 Revision + QRM Digitalization: a Perfect Match
The EU has released its GMP Annex 1 revision after 14 years of development! This blog post gives a few ideas on how to apply it more easily.
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
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.
How Can Digital Cleaning Validation Improve Product Changeover Safety?
Learn how digital cleaning validation solutions can prevent cross-contamination and ensure drug safety during product changeovers in pharma manufacturing.
Previously
Avoiding Common FDA 483 Observations in Cleaning Validation
What are the Regulatory Expectations for Cleaning Validation?
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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