Causal Product & Process Mapping
Regulatory initiatives and frameworks such as ICH Q8, Q9, Q10 and effective product life cycle management have highlighted the need for a science-based causal and mechanistic understanding of all upstream and downstream processes to ensure safe and effective product.
The InSysteA's Causal Process & Product Mapping (CPPM) methodology allows for scientific mapping of the process structure while capturing multivariate cause-and-effect relationships between Process Parameters (PP), Material Attributes (MA) and Product Quality Attributes (QA) with observance of process feedbacks and dynamic process behavior and under consideration of all relevant circumstances (contexts).
The result are InSysteA's unique causal and mechanistic product & process models (CPPM Model).
The CPPM Model covers meaningfull contexts:prior knowledge & experience (refine, capture and make it available in a general accessible format), data and genealogy (upstream / downstream correlations, unit operations, CQA’s evolution, data structure), batches (sensitivity and variations) and sites (technology, equipment, operation & control spaces).
The applied tool (System Dynamics Vensim) allows any user to master multivariate process complexity in a practical and easy understandable way (sensitivity analysis and diagnosis, ...).
Consequently user (customer) will be in a position to master sources and multivariate relationships of variability of the product and process and associated risks with capability to predict their impact on product quality.
As a result, the user (customer) will be able to:
- identify the Critical to Quality parameters and enhance the definition of the process control strategy
- provide knowledge and risk based process design and development
- provide more effective tech transfer and process validation
- maintain a pro-active Product and Process Life Cycle Management
InSysteA posses consolidated knowledge and practical experiences with multivariate application of CPPM methodology through numerous successfully executed applications.
For more information, please contact us.
Risk management
The desired state of reliable product quality and process control requires a deep understanding and mastering of the sources and relationships of process and product variability and associated risks.
This requires the capability to determine what is Critical to Quality (CtQ) based on a multivariate quantitative risk assessment and process control and likely impacts on product quality.
Since current risk management tools (FMEA, CA, FTA, …) are limited in multivariate quantitative Quality Risk Management (QRM), there is a need for a novel, more capable risk management tool.
InSysteA's new innovative and practically proven risk management tool CARISMA (Causal Risk Management)
is based on CPPM Model applying Causal Product & Process Mapping (CPPM) methodology.
Consequently, CARISMA enables user to understand and determine risk propagation along the entire process under consideration of Quality by Design (QbD) Principles and Quality Systems Elements.
As a result, CARISMA allows you to perform:
- Integrated leverage of the risk assessment results determined with standard tools
- Risk assesment understanding probability and multidimensionality of risk propagation
- Multivariate quantified determination of Critical to Quality process parameters and material attributes, as well as of accumulated risk of intermediates and drug product CQA’s (Critical Quality Attributes)
- Investigational risk sensitivity analysis and diagnosis
- Risk-based Quality by Design and Product Life cycle management
In consideration of the fact that CARISMA is based on the CPPM Model of the considered system, CARISMA represents
the first universally applicable multivariate and quantified risk management tool.
The application of the System Dynamics methodology make it possible to leverage CARISMA approach also for risk management of any other complex systems in the field of trading companies, public authorities, insurance companies and banking.
We offer you a demonstration and appropriate system analysis to determine a possible application of CARISMA in your company, please contact us.
Modeling & Simulation
To manage the future means to act in a pro–active manner!
To predict the development of your business requires to know its behavior. Models are simplified but validated representations of your real business system. Models enable to combine customer experience and expertise with data, while simulations demonstrate cause-and-effect understanding of why and how the elements of the system change over time.
Thus, together, models and simulations provide our customers with decisions for better performance.
The models and simulations become the one and only way to provide you with a pro-active management , enable you to think from different points of view and reveal how experiences is turned into successful solutions.
InSysteA's offers knowledge and experience to build unique models and provide simulations that allow you to understand your business' dynamic behavior and thus to predict future scenarios.
The exemplary figure demonstrates the principle of the modeling and simulation approach.
Let us develop and deploy your pro-active approach… for more information, please contact us.