The post summarizes the key principles of CSA, various testing methodologies, risk management, and the benefits of digital software validation tools.
Welcome to the ValGenesis blog, your resource for timely insights from industry-leading experts on the trends, best practices, and new technologies impacting the life sciences.
Mar 22, 2023 12:00:41 PM | In this blog post, we’ll go through some concepts on Knowledge Management and the starting points for its implementation.
In this blog post, we’ll go through some concepts on Knowledge Management and the starting points for its implementation.
The Internet of Things (IoT), sometimes described as an interconnected enterprise system, creates quite the buzz in business circles today. Connecting data, information, and knowledge certainly carries the potential power of creating intelligence to leap ahead of the competition.
Use these 4 conversation starters to overcome the common hurdles to digital validation and make a compelling case for transitioning to a paperless system.
A light story about how ValGenesis joining on a quest to optimize a stage in a process, how did we do it and what came out of it.
This story is about our project with Libbs Farmacêutica to successfully apply a QbD framework in the development of an oral drug product
In this blog post, we will give you all the steps about how to create a PACM protocol and how ICH Q12 supports you in it.
In this blog post, we'll give you some tips that help you setting up a Digital CPV plan in only three steps.
In this blog post, we show you how digital validation can improve your validation process and enhance your business efficiency.
The EU has released its GMP Annex 1 revision after 14 years of development! This blog post gives a few ideas on how to apply it more easily.
If you are looking to reap the full benefits of Continuous Manufacturing, this a post is about how to use PAT for advanced analytics applications.
- 21 CFR Part 11 (1)
- ALCOA+ (1)
- Analytical Method Validation (1)
- Analytical QbD (4)
- Bioequivalent (1)
- Biosimilar (2)
- Cleaning Validation (6)
- Commissioning and Qualification Validation (1)
- Comparability (6)
- Compliance (2)
- Computer Software Assurance (CSA) (16)
- Computer System Validation (CSV) (8)
- Continuous Manufacturing (4)
- Continuous Process Verification (2)
- Data Integrity (3)
- Data Security (1)
- Digital CPV (6)
- Digital Transformation (2)
- Digital Validation (19)
- Electronic Logbook Management (3)
- Electronic Paperless Validation (1)
- Emerging Technology (8)
- Equipment and Instruments Validation (1)
- Facility and Utility Validation (1)
- GMP (1)
- Good clinical practice (GCP) (1)
- Knowledge Management (1)
- PAT (3)
- Pharma 4.0 (2)
- Post-approval Changes (6)
- Process Digitalization (1)
- Process Lifecycle Management (7)
- Process Scale-up (3)
- Product Development (5)
- QbD (6)
- Quality Culture (1)
- Quality Risk Management (24)
- Quality Risk Management Digitalization (10)
- Regulatory Affairs (5)
- Regulatory Requirements (1)
- Remote Inspections (2)
- Requirements Traceability Matrix (1)
- Return on Investment (ROI) (1)
- Risk Management (1)
- Root-Cause Analysis (4)
- Supply Chain Management (3)
- ValConnect (10)
- Validation Projects (1)
- Validation Software (1)
Trending Topics With ValGenesis Customers
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.
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.
ValGenesis Process Manager can help life sciences companies avoid FDA 483s and establish a harmonized cleaning validation program companywide.
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.
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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