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
How Do the FDA's CSA Guidance and ISPE's GAMP 5 Align?
Mar 28, 2024 10:00:00 AM | Learn how ISPE's GAMP 5 Guideline and the FDA's CSA Guidance play complementary roles in ensuring the integrity and reliability of computerized systems.
All Blog Posts
How Do the FDA's CSA Guidance and ISPE's GAMP 5 Align?
Learn how ISPE's GAMP 5 Guideline and the FDA's CSA Guidance play complementary roles in ensuring the integrity and reliability of computerized systems.
Let's Move Beyond Spreadsheets for Risk Management
Discover why Excel is no longer sufficient for effective risk management in the pharma industry and why transitioning to specialized software is crucial.
Best Practices in Commissioning and Qualification ― Part Two
Discover best practices for integrating your commissioning and qualification processes and how to streamline C&Q activities with robust digital solutions.
Best Practices in Commissioning and Qualification ― Part One
Learn best practices for implementing an integrated commissioning and qualification approach and the 5 critical elements to include in your C&Q plan.
Should e‑Logbook Software Work Offline? Yes, Here's Why.
Logbook management software that doesn't work offline deprives you of valuable functionality. ValGenesis iOps is mobile-ready for offline execution.
Why You Should Transition from Pen/Paper to Digital Logbooks
Discover the benefits of digital logbooks and why they are a cost-effective and manageable first step toward broader digital transformation initiatives.
Better Tech Transfers: A Digital Transformation Approach
Learn about rising drug development costs, the role of CDMOs, and how a digital-first strategy can revolutionize tech transfer in the pharma industry.
6 Ts to Drive Computer Software Assurance Adoption
Explore what's needed to successfully adopt the FDA's computer software assurance (CSA) guidance in your life sciences company.
Commissioning and Qualification in Pharma: An Overview
Learn about commissioning and qualification in pharma. Understand the processes involved and the regulatory guidelines to ensure product quality and safety.
Digital Quality Risk Management: A ValGenesis Story
Learn about ValGenesis iRisk, an advanced tool for digital quality risk management, and its impact on vaccine development at a top biopharma company.
Best Practices for Process Validation in the Pharmaceutical Industry
Learn best practices for process validation in the pharma industry. Find out how digitalization streamlines validation operations and improves product quality.
Five Cleaning Validation Challenges Digitalization Solves
This post examines five cleaning validation challenges that can be eliminated by digitizing your cleaning validation approach with ValGenesis.
Build an Effective Data Integrity Program with Risk Management
Understand why data integrity problems occur, and learn how to build an effective, risk-based corporate data integrity program to address them.
Using Digital Twins to Modernize Equipment Qualification
Is digital twin technology the key to achieving compliant, efficient equipment qualification in the modern life sciences manufacturing industry?
6 Ways to Make Your Risk Management More Effective
Improve the efficacy of your risk management process with these 6 strategies inspired by the ICH Q9 quality risk management guideline.
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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
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 Limits Explained: HBEL/MACO, 10 ppm, and 'Visually Clean'
Explore the complexities of cleaning validation limits, including HBEL/MACO, 10 ppm, and visually clean to ensure patient safety and product quality.
Previously
Change Impact Assessments in ValGenesis iClean™: A Framework for Consistency
Unlocking Operational Capacity with Fully Digitalized Cleaning Validation
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