Citation:

Yashwanth Teja Donga, 2026. Computer System Validation and Quality Engineering Alignment for Manufacturing Equipment  Volume 6 Issue 2: 196-206.

Abstract:

Computer system validation (CSV) and quality engineering have often evolved along partially separate institutional paths, although both aim to ensure that manufacturing equipment consistently meets predefined requirements and supports product quality. This review examines how lifecycle validation, process analytical technology, multivariate monitoring, digital manufacturing, and predictive maintenance can be aligned in equipment intensive manufacturing settings. The literature indicates a clear transition from document-centred qualification to risk-based lifecycle assurance, together with increased adoption of in-line and at-line analytics, multivariate statistical methods, cyber-physical architectures, and digital twins. Across the reviewed studies, alignment is strongest when user requirements, critical quality attributes, equipment functions, and data architectures are connected through traceable risk controls rather than treated as isolated validation records. Important gaps remain in model governance, software change assessment, cross-platform calibration, data integrity, and validation strategies for adaptive analytics. These issues are especially relevant to pharmaceutical, biopharmaceutical, and other regulated manufacturing sectors, where equipment is increasingly automated, software-driven, sensor-rich, and data-intensive. Sustained alignment between CSV and quality engineering is therefore essential for maintaining the validated state, operational reliability, and scientifically defensible release assurance.

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Keywords:

Computer System Validation, Continuous Manufacturing, Digital Quality Assurance, Manufacturing Equipment, Quality Engineering.