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.
Apr 20, 2023 9:52:49 AM | This post is about tips to write your User Requirements Specification and how it can improve your processed data and software.
This post is about tips to write your User Requirements Specification and how it can improve your processed data and software.
Pharma has embraced digitization in many business lines, but validation has been one of the few processes to remain manual. Here are 12 reasons to make the switch! (Part 1 of 2)
Today we want to take a fresh look into comparability for post-approval changes. How? We're thinking of a unique multiparametric approach.
This time we tell you how we helped a company finding a root-cause in a Filter Clogging and how we solved it.
Want to learn more about cleaning validation? The use of data collection, analysis, and evaluation are the most critical tasks in a cleaning validation program.
Explore the top 10 business benefits you'll receive from digitizing your paper-based validation processes with ValGenesis.
ValGenesis' global user conference brings together customers, partners, experts and employees for an informative, inspiring and interactive experience.
This blog post will give you an overview of bioequivalence studies and some strategies to streamline your generic drug approval process.
In this blog post you'll know the differences between Manual CPV vs Digital CPV and how we can help you on its implementation.
Computer Systems Assurance CSA prioritizes assurance needs after critical thinking. Here's what you need to address during this crucial part of the methodology.
- 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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