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Key Validation Elements for Automated Processes | IVT

Managing a project typically includes identifying requirements and addressing needs, concerns, and expectations of stakeholders.

Balancing competing constraints include scope, quality, budget, schedule, resources, and risk.

The tables below focus on validation specific items.  These are very high-level and the depth of coverage should be dependent on the scope of the audit, maturity of the validation program, past incidents, and criticality of the validation on product and safety to mention a few.  It is targeted for the validation itself.  Other areas should also be present and examined such as quality, training, etc.

Download the accompanying presentations, "Implement FDA’s New Process Validation Guidance and Other Global Initiatives into Computer and Software Validation Practice Part I and Part II," "Develop a Lifecycle Approach to Computer Validation Part IPart II, and Part III," and "Developing a Robust CSV Training Program" presented at IVT's 2012 Computer and Software Validation EU Conference.

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