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.
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Build an Effective Data Integrity Program with Risk Management
Dec 21, 2023 10:00:00 AM | Understand why data integrity problems occur, and learn how to build an effective, risk-based corporate data integrity program to address them.
Posts about Data Integrity:
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.
6 Best Practices for ALCOA Data Integrity Success
Learn about the significance of ALCOA+ in maintaining data integrity in the pharma industry and best practices for implementing ALCOA+ principles.
Can Blockchain Technology Boost Data Integrity in Clinical Trials?
Blockchain technology is revolutionizing how data integrity is ensured in clinical trials, establishing a new level of trust and compliance.
Data Integrity by Design is Your First Line of Defense!
Each of the above is important. However, the critical point is that data integrity should be designed into the system right from the beginning. Data integrity should be at the forefront of system development (i.e, design).
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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.
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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.
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.
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Game-Changing Tech Paves Way for Better Cleaning Validation Outcomes
Maximize the Use of Technology to Access Real-Time Clean In Place Data
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 ...
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