CSV and CSA FAQs: Practical Answers for Life Sciences Validation Teams
Get practical answers about CSV, CSA, risk-based testing, assurance needs, documentation, requirements, and ValGenesis support for software validation.
Latest News
Better Pharmaceutical Development: A Case for ValGenesis iCMC
Aug 8, 2024, 10:00:00 AM | See how ValGenesis iRisk transforms pharmaceutical development by integrating QbD and AQbD, streamlining processes, improving quality, and expediting approvals.
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Better Pharmaceutical Development: A Case for ValGenesis iCMC
See how ValGenesis iRisk transforms pharmaceutical development by integrating QbD and AQbD, streamlining processes, improving quality, and expediting approvals.
Top 5 Misconceptions About Computer Software Assurance
As life sciences companies work to ensure the quality and safety of their software systems, it's essential to understand the true intentions and uses of CSA.
Driving Success with Digital C&Q and Pharma 4.0
Learn about the benefits and impact of transitioning to digital C&Q solutions for enhanced efficiency, compliance, and innovation in a Pharma 4.0 world.
Avoiding the Pitfalls of PQRs with Digital Solutions
Learn to enhance Product Quality Reviews (PQRs) with digital solutions that drive quality improvement and regulatory compliance in pharma manufacturing.
Transcat Streamlines Equipment Qualification with ValGenesis VLMS
This case study highlights the transformative impact of VLMS technology to modernize equipment qualification processes and drive operational excellence at Transcat.
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Should You Use QRM Software for ICH Q9 (R1) Compliance? Yes!
Quality risk management software ensures compliance with ICH Q9(R1) guidelines, enhancing risk assessments, decision-making, and product safety in pharma.
ValConnect 2024: A Global Gathering in Lisbon
Discover the highlights from ValConnect 2024, showcasing cutting-edge technologies, customer success stories, and the unveiling of ValGenesis VLMS 5.0.
What's Stopping You? Overcoming CSA Adoption Concerns
Explore the benefits of computer software assurance for software validation in life sciences. Learn how digital tools address common fears of CSA adoption.
Harnessing the Power of Machine Learning for R&D in Drug Discovery
Machine learning (ML) is transforming early-phase drug screening, enhancing efficiency and predictive accuracy. Learn how to apply it to your R&D process.
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ValGenesis VLMS 5.0: Next-Gen Validation Lifecycle Management
Explore how ValGenesis VLMS 5.0 marked a key milestone in the evolution of digital validation lifecycle management, paving the way for today's iVal solution.
How to Apply a Quality by Design Framework with ValGenesis iCMC
Learn how ValGenesis iCMC integrates Quality by Design principles with CMC lifecycle management to enhance pharmaceutical process development.
Maximize Operational Efficiency with ValGenesis e‑Logbook
Revolutionize pharma operations with ValGenesis e-Logbook. Streamline data entry, enhance compliance, and drive efficiency in manufacturing processes.
How Integrating Risk Assessment and CPV Increases Patient Safety
Integrating risk assessment and continued process verification with digital technology enhances patient safety and optimizes processes in the pharma industry.
Real-Time Monitoring in Pharma: Why It Matters and How to Get It Right
Discover the importance of real-time process monitoring in pharma manufacturing. Explore how RTM enhances efficiency, quality, and compliance.
Best Practices for Impact Assessments in Cleaning Validation
Explore best practices for impact assessments in cleaning validation, including strategies for using technology to streamline the assessment process.
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Featured Content
Quality Risk Management
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
Tech Transfer & Process Scale-up
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
Cleaning Validation
Risk-Based Cleaning Validation: A Lifecycle Approach
Explore the evolution of pharmaceutical cleaning validation from compliance-focused practices to a risk-based, lifecycle-driven approach.
Written by
Kenneth Pierce
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
ValConnect Innovation Day Princeton: A Glimpse into the Digital Future of Life Sciences
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.
Cleaning Validation in Pharma: FAQs on Limits, Risk, and Control
Explore practical FAQs on cleaning validation in pharma, including regulatory expectations, limits, lifecycle stages, sampling, change control, and digital execution.
Previously
Dirty and Clean Hold Times: Setting Defensible Limits for Cleaning Validation
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