What Is It and How Does It Work?
There are four levels of readiness in our unique scoring system. The scoring system is broken down by production level timelines: three, six, nine and twelve months. Using this innovator-defined process, you choose how much readiness is necessary from clinical to commercial scale. Alleviate potential pinch points, concerns in your supply chain and brand equity with Alcami's State of Readiness system.
GAP Assessment of the Defined Process:
- Technical Review of Process for Facility Fit
- Review of Analytical Methods and Fit for Purpose
- Review of Batch Records for the State of Readiness
- Regulatory Change/Process Validation Assessment
- Supply Chain/Vendor Status Assessment
- Trending of Available Stability Data
- Raw Materials and Vendor Status
- Test Methods and Specifications
- Process and Facility Fit
- Client’s Current Situation
- Product Phase
- Capacity Needs
- Client Supplied Material Availability
With this information and our expertise, Alcami takes an educational approach in providing clients a Current Risk Level and Readiness Summary which lays out a readiness strategy for each of the four levels.
Determining Your Readiness Strategy
The future of your supplier relationship is dependent on how ready you want your supplier to be for unexpected supply setbacks. With your input and Alcami’s supply chain assessment, we can determine the right level for your company and work together to execute a plan to reach that desired readiness timeline.
Your supply chain is as strong as you make it. The State of Readiness system puts the control in your hands. With so many complex risks throughout your supply’s lifecycle, do you control your supply chain or do you leave it up to chance?