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 expereince 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.
- Employee Risk Management and Process Mapping Techniques
- Develop Operating Strategies for Cost Effective Operations and Maintenance
- Apply Lean Principles that Achieve Business and Compliance Goals and Objectives
- Reduce Project Soft Costs
- Streamline Documentation Practices
- Increase Project Efficiency
- Shorten Project C&Q Timelines
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
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Meet the Expert: Chuck Stock, CxA, Lean CertifiedChuck 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. |
