IPS provided technical consulting and streamlined strategies based upon a risk- and science-based approach applied to the Facilities and Equipment (F&E) Lifecycle of Design, Specification, Construction, Commissioning and Qualification. To make these improvements in its F&E Lifecycle processes, the Client had to transform their current process of how engineering, design and verifications are performed. This included the breakdown of the traditional roles of the staff as well as the role of the quality unit in the process.
IPS assisted in the development and implementation of new approaches and practices to streamline engineering and validation processes using current risk- and science based approaches found in ASTM E2500, ICH standards and the current ISPE C&Q guidelines. The team also provided policy and standard operating procedure consultation and procedure development, engineering and validation consulting, and project management. The project was phased to include development of key policies and guides in the earlier phases. The later phases include execution of specific procedures along with lessons learned to create an iterative process based on continuous improvement.