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.
Sep 14, 2023 9:00:00 AM | This post is the second installment of a two-part series on the incredible impact of generative AI, particularly ChatGPT, on validation in the life sciences.
Posts about Digital Validation:
This post is the second installment of a two-part series on the incredible impact of generative AI, particularly ChatGPT, on validation in the life sciences.
This post is the first installment of a two-part series on the incredible impact of generative AI, particularly ChatGPT, on validation in the life sciences.
Spreadsheet tools like Excel raise a regulatory red flag and can trigger an audit. Your best defense is a validation lifecycle management system (VLMS).
Writing good requirements during the requirements management process is the key to better product quality, accelerated development, and less rework.
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)
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.
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)
- 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) (9)
- Continuous Manufacturing (4)
- Continuous Process Verification (2)
- Data Integrity (2)
- Data Security (1)
- Digital CPV (6)
- Digital Transformation (2)
- Digital Validation (19)
- Electronic Logbook Management (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 (4)
- Process Digitalization (1)
- Process Lifecycle Management (7)
- Process Scale-up (3)
- Product Development (5)
- QbD (6)
- Quality Culture (1)
- Quality Risk Management (22)
- Quality Risk Management Digitalization (10)
- Regulatory Affairs (5)
- 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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