How Do the FDA's CSA Guidance and 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.
Latest News
Planning Is Well Underway for ValConnect 2022
Apr 20, 2023 9:49:00 AM | ValGenesis' global user conference brings together customers, partners, experts and employees for an informative, inspiring and interactive experience.
Posts about ValConnect:
Planning Is Well Underway for ValConnect 2022
ValGenesis' global user conference brings together customers, partners, experts and employees for an informative, inspiring and interactive experience.
ValConnect 2022 – Day Two Round-Up
Day two of ValConnect 2022 featured a live demo of ValGenesis University and a keynote from FDA's Cisco Vicenty. Read the recap!
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.
ValConnect 2022 – Day Three Round-Up
ValConnect 2022 is a wrap! Read the recap, and watch today's keynote from Dr. Ajaz Hussain. See you next year!
ValConnect 2022 Session Round‑Up: Philips Harmonizes CSV Processes
Philips needed a digital validation system that could standardize its paper-based computer system validation (CSV) efforts across multiple geographies.
ValConnect 2022 Session Round-Up: The Power of "New Science"
New Science can deliver accessible, affordable, and transformative patient outcomes when built on well-defined outgrowth strategies that access emerging technologies.
ValConnect 2022 Session Round-up: CPV for New and Legacy Products
“CPV is a broader concept because it gives you a more holistic picture of overall product performance over a period of time. While both APR and CPV give you an indication of product performance, the current situation in most companies is that they remain disconnected".
ValConnect 2022 Session Round-Up: Standardizing Validation Across 19 Sites
Roche/Genentech eliminated 50% of the non-value-added paper-based tasks employees were forced to perform and reallocated resources to prioritize innovation.
ValConnect 2022 Session Round-Up: Building a Digital-First Culture
Digitalization and the Pharma 4.0 vision appeals to young generation engineers from ‘career development’ and ‘cultural engagement’ perspectives.
ValConnect 2022 Session Round-Up: Are Quality & Compliance the Same?
The evolution from compliance to a proactive learning system focused on patient quality outcomes involves overcoming several barriers, says FDA.
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
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.
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.
Previously
Five Cleaning Validation Challenges Digitalization Solves
Game-Changing Tech Paves Way for Better Cleaning Validation Outcomes
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.
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 ...
Previously
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