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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.
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Risk Management for Medical Devices
Apr 12, 2023 11:11:16 AM | Many medical device companies have struggled with implementing a risk management process that results in risk being mitigated to the level of AFAP.
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Risk Management for Medical Devices
Many medical device companies have struggled with implementing a risk management process that results in risk being mitigated to the level of AFAP.
Q&A About Compliant, AR-Driven Hands-Free Validation
AR-driven hands-free validation isn’t just a futuristic concept; it’s available now. In this insightful Q&A, Steve Thompson discusses how it will transform GMP production environments.
New ICH Q14 Guideline: key Implementation Aspects
The ICH released a draft version of the new ICH Q14 Guideline last March. This blog post will give you an overview of its key implementation aspects.
ValConnect 2022 – Day One Round-Up
ValConnect 2022 is off to a great start! Today's agenda featured live product demos and a keynote from Roche/Genentech. Here's a recap of day one.
Commissioning and Qualification in the Life Sciences
Traditional commissioning and qualification can be very challenging due to the inefficiencies, compliance risk, lack of data integration, inability to adequately track and close out activities.
Transitioning From CSV to CSA
The upcoming transition from CSV to CSA models reduces the cost of validation and provides a more risk and science based approach.
The X Factor for Successful Digital Transformation in BioPharma: People
This current era of biopharmaceutical manufacturing is a most challenging and exciting time for our industry. Technology breakthroughs, intensifying competition, and continually rising performance expectations from patients, stakeholders, pressure from government bodies for cost reduction, and regulators necessitate rapid change in execution.
4 Life Sciences Lessons from the PAT to QbD Journey
In our journey to instill quality culture across life sciences, we've learned several valuable lessons along the way. The bottom line: continued training and development matters more than ever.
Cleaning Validation Stage 2: Performance Qualification
The second stage of the validation lifecycle is called Process Qualification. This stage is customary and is referred to as Cleaning Validation. Usually, three consecutive successful runs are performed to qualify the process using well characterized, well documented and consistent cleaning procedures.
FDA's Computer Software Assurance (CSA) – Part 1 of 3
Traditional computer software validation (CSV) focuses on documentation. Computer software assurance (CSA) focuses on critical thinking.
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.
Boost Efficiency with Digital Equipment Qualification and Validation
Traditional equipment validation is a manual, inefficient paper-based process plagued with bottlenecks and high cost. It's time to go digital.
Critical Thinking and Its Role in Computer Software Assurance (CSA)
Critical thinking is a vital life skill and the principal requirement of CSA. Are you a critical thinker? Read on to find out.
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.
Computer Software Assurance (CSA): Focus on Records, Not Documentation
The thinking is the more paper you generate, the better you validate. According to the FDA, this is not only wrong, it's dangerous.
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Featured Content
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
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
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.
The Real Cost of Bottlenecks: Why Manual Cleaning Validation Increases Regulatory Risks
Discover why manual cleaning validation increases regulatory risk and how digital solutions can enhance data integrity and compliance in pharma operations.
Previously
Digital Cleaning Validation: From Lifecycle Control to Real-Time Assurance
Risk-Based Cleaning Validation: A Lifecycle Approach to Compliance and Efficiency
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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