The closer a new medicine gets to market the larger the financial risks become. It’s not surprising, then, that one of our customers was wary about building a new production facility for its latest product until that product had safely achieved FDA approval.
With the milestone secured, focus immediately turned to reaching the market as soon as possible. However, a stringent quality focus was also needed to minimize the risk of any setbacks or delays due to incorrect product quality.
Our proposal was based on an integrated agile approach that would allow us to work closely with the customer from an early phase.
Focus also included early identification of key value-adding activities (e.g. standardization and achieving correct levels for applications, documentation and validation).
Key successes delivered during the project included:
- A Benefits and Value Management approach from the outset – reducing risk and enabling the project to quickly start generating value.
- Gaining early acceptance of a standard solution – reducing the time and cost for development, documentation and validation.
- Building a copy of the system for test and simulation – allowing errors to be picked up early, the final result to be visualised at an early stage, and enabling operators to be trained in the simulator while the solution was still under development.
- A smart, integrated engineering and documentation system – helping to reduce the scope for errors and shortening development time from idea to final factory.
- A close, articulated and well-established collaboration between the customer, validation and technical aspects – minimizing project time and ensuring fewer deviations.