Computerized System Validation (CSV) vs Agile Development
Incorporate governance maturity and audit assurance quality into procurement scoring so total risk cost is reflected in vendor selection.
CyberTRIZ analysis · Pharma contradiction V002 · one of 8,235 worked contradictions published by CyberTRIZ.AI
Regulations
Business Context
Software development increasingly follows Agile methodologies characterized by rapid iterations, continuous improvement, incremental releases, and close collaboration between developers and users. These approaches accelerate software delivery while improving responsiveness to changing business requirements. Traditional CSV methodologies, however, often assume sequential project phases with comprehensive documentation completed before implementation. This apparent mismatch frequently creates tension between software development teams and validation specialists.
The Contradiction
Agile development increases implementation speed. Traditional CSV may slow iterative software delivery.
Why It Exists
The contradiction results primarily from validation processes rather than regulatory requirements. Validation is frequently interpreted as extensive documentation instead of documented evidence demonstrating that systems remain fit for intended use throughout their lifecycle.
Applying Pharmatriz
Modern CSV can successfully coexist with Agile development by validating incremental releases, maintaining automated traceability, applying risk-based testing, and integrating validation activities into continuous development cycles.