Cymapp® for the
The pharmaceutical sector operates in a highly regulated and complex context where regulatory compliance is essential to ensure patient safety and product quality.
In this context, the Cymapp® relational mapping model allows pharmaceutical companies to make quick, informed decisions for effective risk management, overcoming the limitations of most traditional approaches.
All the advantages
Why a Pharmaceutical Company Should Use Cymapp®
- It ensures alignment with ICH Q8 and ICH Q9 guidelines, which are essential for the
development of processes and products, guaranteeing quality through a Quality-by-Design
approach. - Allows for the analysis of process deviations or out-of-specification (OOS) results, anticipating
critical variables that may compromise product quality and minimizing waste. - Facilitates technology transfer, ensuring consistency between development phases and
manufacturing sites.
- It automatically generates structured, complete FMEA reports that are fully integrated with the process mapping, simplifying inspections by regulatory authorities and accelerating decision- making.
- Identifies each critical process parameter, enabling the demonstration to regulatory authorities of an in-depth understanding of the product and process.
- Facilitates change and control management activities by evaluating the impact of each change before implementation, reducing risks associated with modifications.
Transform Risk Management
The difference between Cymapp® and other similar solutions on the pharmaceutical market is substantial
Quality Deviations
With Cymapp
All necessary information viewable in a single tool
Without Cymapp
Manual Research through Company Documentation
Knowledge management
With Cymapp
Dynamic: Flexible, incremental, and immediate approach.
Without Cymapp
Static: Forces a comprehensive review of all company documentation.
Costs
With Cymapp
Reduced due to centralized, structured, and more efficient management of information and
Without Cymapp
High due to the unavailability of information and fragmented knowledge.
Investigation time
With Cymapp
Reduced thanks to the centralization of information and the intuitiveness of the Visual Knowledge Management System.
Without Cymapp
Extended due to the fragmentation of available information.
Want to find out how Cymapp® can help you manage your pharmaceutical business?
Take action.