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IPS

ASTM Expertise

  •  For a recent client, we developed new processes to speed the turnover of capital projects and enhance life cycle maintenance and management.

 

  • Our implementation efforts significantly reduced redundant qualification testing and validation deviations.

Science- and Risk-based Engineering through Validation

Transitioning requires experience and expertise. Our team works with you to develop and execute a realistic plan that reflects your critical milestones, goals and objectives and outlines the activities required for a successful completion.

It is our experience that implementing this approach results in improved project cycle times, better online time performance and a simplified and defendable compliance profile.  We apply our unique methodologies to both new and existing facilities.

Our approach and expertise in Engineering, Construction and C&Q has been the cornerstone of our success for over 20 years.

Expert Insight

Implementing the ASTM standard for verification: Standard’s key objective is to give industry-wide flexibility regarding implementation”, Chuck Stock, CxA, Lean Certified, CleanRooms, October 2007

 

Meet the Expert: Chuck Stock, CxA, Lean Certified

Chuck has implemented lean approaches based on current ASTM E2500 and ISPE standards and guides at several branded pharmaceutical companies. He and his team completed a detailed operations strategy for a large cell therapy manufacturer that resulted in substantial reductions in planned staffing and improved compliance through lean principles.