Lean Validation

Lean Validation: Common Sense IV&V

Lean manufacturing is the systematic method for the elimination of waste ("Muda") within a manufacturing system. Lean manufacturing also takes into account waste created through overburden ("Muri") and waste created through unevenness in work loads ("Mura"). 

 

Based on the principles and concepts of lean manufacturing, OnShore defines lean validation as the delivery of independent validation and verification (IV&V) services with minimal waste, over work and structured consistent processes to ensure quality, efficiency and compliance. 

 

The pressure to achieve compliance while minimizing costs is a real concern for validation engineers.  For decades, validation engineers have struggled to apply regulatory guidelines coupled with industry best practices to achieve compliance.  However, many IV&V projects have included non-value added work (“muda”) and a lot of over work/over-doing (“muri”) caused by changing standards and regulatory requirements.

 

Today’s advanced technology, especially cloud-based solutions and cybersecurity, call for a re-thinking of how we validate systems.  We endeavor with each project to minimize waste and eliminate much of the overwork that characterizes too many validation projects.  We leverage advanced tools and techniques to streamline validation efforts and ensure compliance.   Click here to read more about our lean validation strategies for enterprise and cloud-based solutions. 

 

The pillars of lean validation principles we follow are illustrated in the figure below.

 

Figure 1 - OnShore Technology Group's Lean Validation™ Methodology

The pillars of our lean validation methodology are explained below.

Eliminate Waste in IV&V Processes

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Minimize Risk

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Optimize IV&V Processes

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Increase Efficiency Across IV&V Processes

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Drive Quality

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Ensure Compliance

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