Map processes.
Manage risks.
Make informed decisions.
Cymapp® is the Visual Knowledge Management System that turns FMEA into an
Distinguish what you
know from what you
think you know
Identify and analyze industrial and business processes with a structured approach
Build a knowledge system that anticipates and prevents risks before they become damage,
turning compliance with ICH Q9 (Quality Risk Management) and ICH Q8 (Quality by
Design) into a tool for strategic management and continuous improvement.
Risk analysis
is always about
the future
Map and anticipate
in advance
Identify process criticalities both in the design and industrial phases, providing the necessary
tools for effective Root Cause Analysis. highlight inefficiencies, out-of-specifications, or
process deviations that could compromise quality, and improve process repeatability.
The tool brings
focus where it
truly matters
Evaluate and control the impact
of corrective actions
Collect development and validation information, transforming it into practical, organizational
tools (FMEA) to improve performance, reduce waste, and optimize processes based on
objective and measurable criteria.
Quality should not be the result of trial and error,
but the outcome of clear design from the very beginning.
This is the principle that radically transforms Risk Management through the Quality by Design
approach: compliance evolves from regulatory requirement into a strategic advantage.
It all starts with mapping:
the value of PTM consultancy
PTM’s Methodology
Originally developed as an internal tool for process understanding, Cymapp is the result of the
expertise PTM Consulting has gained in Risk Management methodologies and Quality by
Design applications over 20 years of collaboration with pharmaceutical industry leaders.
A proprietary system for mapping and managing information, which we have chosen to make
available to our clients.
Cymapp can be applied to various types of processes, both physical and those involving the
transformation of information or data.
Why choose Cymapp®:
Process mapping and risk analysis in a single dynamic and intuitive tool
- Represents processes in a visually clear and intuitive way.
- Highlights causal relationships and enables backward analysis of production variables that influence the outcome.
- Significantly reduces subjectivity in risk assessment, ensuring decisions are based on
concrete data. - Analyzes processes continuously, adapting to new conditions and ensuring constant
updates to risk assessments. - Seamlessly integrates with existing FMEA systems, overcoming their structural
limitations. - Offers a web-based application with immediate access.
Key Application Areas
Who is Cymapp® for?
Pharmaceutical
Provides the ideal tool for patient safety, process and product quality improvement, and full regulatory compliance.
Equipment for
Pharmaceutical Companies
Improves design efficiency by reducing risks during the design phase of the process (equipment) and provides all necessary documentation for customer compliance.
Combination Product
Manages risk analysis by integrating regulatory requirements in all relevant areas, facilitating both product and process development.
Other industries
The ideal solution for all sectors where quality management of processes and products is crucial for business success (aerospace, automotive, food, precision mechanics).