The post summarizes the key principles of CSA, various testing methodologies, risk management, and the benefits of digital software validation tools.
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Mar 22, 2023 12:00:59 PM | Traditional equipment validation is a manual, inefficient paper-based process plagued with bottlenecks and high cost. It's time to go digital.
Traditional equipment validation is a manual, inefficient paper-based process plagued with bottlenecks and high cost. It's time to go digital.
Critical thinking is a vital life skill and the principal requirement of CSA. Are you a critical thinker? Read on to find out.
There's a need to accelerate pharma product development and process scale-up. Having an effective tech transfer strategy can help you.
The thinking is the more paper you generate, the better you validate. According to the FDA, this is not only wrong, it's dangerous.
Digital validation and automation meet complex product lifecycle needs but they're only enablers to the intelligence at the heart of manufacturing activity. Learn how ValGenesis is expanding its product vision beyond validation toward a holistic manufacturing intelligence platform.
ValConnect 2022 is a wrap! Read the recap, and watch today's keynote from Dr. Ajaz Hussain. See you next year!
Changing mindsets from compliance-centric to quality-focused isn’t easy. It’s possibly the most difficult change to make, but it’s necessary for a quality culture to take hold.
Each of the above is important. However, the critical point is that data integrity should be designed into the system right from the beginning. Data integrity should be at the forefront of system development (i.e, design).
Cloud-based digital validation allows you to recover in the event of a disaster, ensuring business continuity and compliance.
An important, and sometimes challenging, step in every product lifecycle is the point when it gets its premarket or a postmarket regulatory approval by the FDA. Luckily, through a combination of good practices for Benefit-Risk Assessment and technology, this has become much easier.
- 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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