Smart-QC: Main Goals and Impact on Enterprise QC:

§         A Standardized application for planning and budgeting across multiple geographically dispersed lab operations.

§         Identifies capacity expansion needs

§         Ability to perform “What-if” analysis at an aggregate level as well as at the site specific level (i.e., Stability, Raw Material release)

§         Use common Key Performance Indicators and terminologies to evaluate performance across sites and benchmark them against internal and external best practices

§         Proactively smooth variable work load across sites with minimal cost and service level impact

§         One common platform for productivity improvement projects justification

Smart-QC: Resources Modeling - Importance

§         Capacity Modeling is one of the most critical elements in designing a new laboratory, expanding an existing QC operation, or conducting a feasibility check and "what if" analysis stage.

§         It combines required capacity from various demand sources - such as clinical products, current and future commercial products, etc.

§         Resource Modeling provides the translation of demands in terms of staffing, instruments, utilities, space, etc.

Smart-QC General Usage

§         Resources requirements:

–        Calculate the required analysts at each lab based on various forecast scenarios

–        Instruments requirements

•          Define short falls / excess capacity

§         “What if” analysis

–        Campaign size effect

–        Standards changes / process improvements

–        Forecast changes: volume / mix / new product

–        More …

§         Percent of time analysts spend on admin., preparation, set-ups, calculations: Value Added (VA) vs. NVA

§         General reports / KPI

There are 5 Types of demand forecasts that affect long term resources planning