What's the problem that you're solving? Method to build a pharma manufacturing enterprise in the abstract, using FDA’s PAT framework leveraging ISA-95 (industry standard), to model future process states and validate against GAMP standards.
Why is the problem important and what is the business value? Provide a unique method to assist pharma’s to
transition existing processes to the new FDA approved process
optimizing their production lines
glean new products from existing capabilities
engineer innovation in the production area.
Why is your solution better than other solution that exist State of the art in the industry uses real time and historical SCADA data to tailor production lines. Because this situation limits possibilities to the known, it limits engineering innovation to the boundaries of the ‘real world’, not theoretical as you can do in the abstract. Additionally, by including the other domains of enterprise architecture, a holistic look at the pharma allows
Organizational change
Supply chain optimization
External systems optimization
One of the core principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process. As a result, GAMP covers all aspects of production; from the raw materials, facility and equipment to the training and hygiene of staff. Standard operating procedures (SOPs) are essential for processes that can affect the quality of the finished product.