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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Jul 20, 2023 10:00:00 AM | How do we deliver objective evidence with a high degree of certainty it will withstand regulatory scrutiny? Technology tools like a VLMS hold the answer.
Posts about Validation Software:
How do we deliver objective evidence with a high degree of certainty it will withstand regulatory scrutiny? Technology tools like a VLMS hold the answer.
- 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)
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