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
Adopting Continuous Manufacturing (CM): The Case of Biologics
Mar 22, 2023 11:59:22 AM | Continuous Manufacturing brings quality and delivery many business gains when applied to biologic products.
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Adopting Continuous Manufacturing (CM): The Case of Biologics
Continuous Manufacturing brings quality and delivery many business gains when applied to biologic products.
Cell and Gene Therapy: the Benefits of PAT and QbD
Cell and Gene Therapy products are considered the future of medicine. PAT and QbD can bring many benefits to C>
Digital Transformation: Impacting Global QRM
A blog post about applying digital transformation to the QRM of the top-tiers of the Pharmaceutical Companies and how it can benefit them.
Optimizing a Perfusion Cell Culture: a ValGenesis Story
This is a post about optimising a perfusion cell culture, using a combination of Root Cause Anlysis and Corrective and Preventive Action.
Medical Cannabis: the QRM Practices that Improve Your Business
A blog post where we give you some tips on how Quality Risk Management can help you improve your Medical Cannabis business
QRM System for ATMPs: Time to Make it Digital
ATMPs are a field that is new, complex, and specific. Having a digital QRM System for ATMPs can have a strong impact in your operations.
Digital CPV Implementation: how to do it?
This blog post will give you a few tips on how to do a CPV implementation and the different requirements you need to make it successful.
Risk Management of Sterilising Filtration
In this blog post we will talk about the perform Risk Management of Sterilising Filtration. We present the steps, the methods and the tools!
How to Support Global Manufacturing of Pharma Products
Process, product performance and comparability are key to global production. This is how to support global manufacturing of pharma products.
Tablet Computing in GMP Environments: Flashy Gadget or Useful Tool?
This post examines four reasons tablet computers are ideal for validating computer systems, equipment, and instruments in controlled GMP manufacturing environments.
Paperless Validation Trends in Pharma, Biotech, and Medical Devices
Paperless validation technology has been available for over a decade, but the life sciences industry has been slow to adopt it. But things are changing.
Business Continuity and Disaster Recovery in FDA-Regulated Industries
Digitization is the process of converting text, pictures (including video), and sound into a digital form that can be processed by computer technology.
Greenfield CDMO Sees Digital Validation as a Competitive Advantage
Faster innovation and time to market are top priorities for CDMOs. Being a digital-first organization gives Theragent a substantial competitive advantage.
Accelerate Time-to-market Using a QbD Framework: a ValGenesis Story
We write about how we helped a company in accelerating the time-to-market of a drug product using a Quality by Design (QbD) framework
ROI Study: Digitizing Validation Yields 50% Overall Efficiency Gain
ROI study reveals how much time and money customers save by digitizing corporate validation processes. Watch the webinar (link in post).
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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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