Risk and Compliance Management

Compliance refers to the necessity to observe laws and external regulations.  Business companies are required to fulfil regulatory requirements and to provide the appropriate documented proof for this. At the same time, today’s businesses are caught up between tight costs, personnel requirements, benefits, actual security and avoidance of over regulations. In order to strike a balance between complexity and benefit we have introduced the term „lean validiation“ which we understand to mean compliance security at an affordable price.
 
The role of compliance management is to identify, implement and test the effectivity of the valid laws and the measures that come with them while considering the importance of documentation.
Special emphasis is put on systematic risk recording and assessment in the process as well as the facilities applied or computer systems which can have influence on product quality.
 
Our Services:

• Conception and design of risk based compliance management systems (from strategy to operational implementation)
• Support in implementation of regulatory requirements (FDA, GxP, MPG etc.)
• Qualification and validation of processes, equipment and systems
• Selection of methods and tools for analysis of risks with regard to processes, systems and products
• Integration of risk & compliance management in the existing QM systems

Advantages of our Services:

• Long term experience in risk & compliance management (across sectors, systems and processes) and quality management
• Pragmatic field-tested methods and tools
• A standardised but flexible procedure
• Reduction of initial costs, current costs and complexity
• Increasing process understanding within the scope of compliance management