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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May 5, 2022 12:00:00 PM | CSA is achievable under current regulation. If you’re following these 3 core CSV principles, odds are you’re already aligned with the new CSA methodology.
CSA is achievable under current regulation. If you’re following these 3 core CSV principles, odds are you’re already aligned with the new CSA methodology.
We write about how we helped a company in accelerating the time-to-market of a drug product using a Quality by Design (QbD) framework
ROI study reveals how much time and money customers save by digitizing corporate validation processes. Watch the webinar (link in post).
When manufacturers rely on paper-based logbooks, they expose themselves to human errors, poor data integrity, and a host of compliance risks.
Technologies like blockchain, AI, ML, and AR have the potential to revolutionize validation methods and catalyze companies transitioning to Pharma 4.0.
Manual requirements traceability matrix generation is error-prone and costly due to the resources and time required to maintain them during the validation lifecycle.
"Digitization Of Validation For Effective Virtual Regulatory Inspections" wins IVT's Voices in Validation 2021 Podcast of the Year Award. Read transcript.
Stage 3, CPV, encompasses validation maintenance or verification that the qualified cleaning process continues to perform consistently.
Saving bottom-line costs of paper and paper storage is just one benefit of paperless validation. Also at stake: disaster recovery, using big data intelligently, and keeping remote teams productive.
Paperless validation lifecycle management systems empower regulators to conduct effective off-site regulatory reviews and inspections.
- 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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