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 10:28:31 AM | This blog post will give you an overview of Analytical QbD and why it's important to implement it in your method development.
This blog post will give you an overview of Analytical QbD and why it's important to implement it in your method development.
The efficiencies gained, according to ValGenesis customers, range from 50% to 80% improvements. This lessens demand and allows more time to be focused on higher priority tasks. Knowing the ValGenesis VLMS ensures controls and standards are followed, according to customer-specific requirements, stakeholders are given a high-degree of assurance that Quality is ingrained in the process.
How to connect already existing AQbD with the new ICH Q14? Jean-François Dierick and Claudia Magagnoli from GSK explained us how!
Paper-based workflows have been the industry standard for validating systems and processes. But companies gain many benefits from going digital. (Part 2 of 2)
This post examines the crucial impact quality culture has on individuals, organizations, and processes; it offers tips for improving it in your company.
If you think of validation as a pie, document authoring is 25% of the pie. A DMS can’t address the other 75% of validation activities ValGenesis supports.
ValGenesis (VLMS) has capitalized on delivering functionality to support object-oriented validation. Here you can create requirements as objects, and these can be shared.
An efficient control strategy will ensure your processes performs always as expected. In this blog post we described the steps to design one.
This a story about how we helped a company with their biosimilarity assessments and to avoid massive time-to-market delay!
ValGenesis validation lifecycle management systems provide a solution that eliminates all the inefficiencies that plagued paper-based cleaning validation processes.
- 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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