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ValConnect Innovation Day Princeton: A Glimpse into the Digital Future of Life Sciences
ValConnect Innovation Day Princeton brought Bayer, GSK, Cardinal Health, Transcat & Hansa Biopharma together to explore AI & Smart GxP™ in life sciences.
Latest News
ValGenesis Podcast on Virtual Inspections Wins Podcast of the Year
Nov 10, 2021 8:45:00 AM | "Digitization Of Validation For Effective Virtual Regulatory Inspections" wins IVT's Voices in Validation 2021 Podcast of the Year Award. Read transcript.
ValGenesis Podcast on Virtual Inspections Wins Podcast of the Year
"Digitization Of Validation For Effective Virtual Regulatory Inspections" wins IVT's Voices in Validation 2021 Podcast of the Year Award. Read transcript.
Cleaning Validation Stage 3: Continued Process Verification
Stage 3, CPV, encompasses validation maintenance or verification that the qualified cleaning process continues to perform consistently.
“No Paper” is Only 25% of the Benefit of “Paperless” Validation
Saving bottom-line costs of paper and paper storage is just one benefit of paperless validation. Also at stake: disaster recovery, using big data intelligently, and keeping remote teams productive.
Digitize Validation for Remote Regulatory Reviews and Inspections
Paperless validation lifecycle management systems empower regulators to conduct effective off-site regulatory reviews and inspections.
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
The Benefits of Automating Your Requirements Traceability Matrix
Catalent's Journey of Continuous Improvement for CSV Excellence
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.
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Why Cleaning Validation Still Tops FDA 483 Observations
Explore why cleaning validation remains a top FDA 483 observation, its regulatory history, and ongoing importance. Part 1 of our Future of CV series.
Previously
What Are the Regulatory Expectations for Cleaning Validation?
Why Modernizing Cleaning Validation Is Crucial for Compliance
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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