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.
Dec 7, 2023 10:00:00 AM | Improve the efficacy of your risk management process with these 6 strategies inspired by the ICH Q9 quality risk management guideline.
Improve the efficacy of your risk management process with these 6 strategies inspired by the ICH Q9 quality risk management guideline.
Explore the key aspects of ICH Q12 and a 5-step structured framework for effective post-approval change management (PACM) agility.
All systems, equipment, and processes that have GxP impact require validation. Here are the different types of validation in the pharmaceutical industry.
Learn about the significance of ALCOA+ in maintaining data integrity in the pharma industry and best practices for implementing ALCOA+ principles.
Learn about FDA 21 CFR Part 11 compliance and the regulatory requirements for electronic records and signatures in the life sciences industry.
Examples from real FDA warning letters show the risks and consequences of using paper logbooks and why a digital logbook management solution is essential.
In this post, we'll explore the transition to paperless validation and the benefits it brings such as efficiency, cost reduction, and compliance assurance.
Learn how to simplify regulatory approval for post-approval changes and discover the benefits of implementing a PACM protocol and using a QRM platform.
Explore the essential role of CPV in your manufacturing process and discover the transformative impact of going digital in this blog post case study.
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.
- 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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