The comprehensive Risk Management System considers all
aspects involved:
Risk Assessment
A
systematic process of organizing information to support a risk decision to be
made within a risk management process. It consists of the identification of
hazards and the analysis and evaluation of risks associated with exposure to
those hazards.
Risk Evaluation
The
comparison of the estimated risk to given risk criteria using a quantitative or
qualitative scale to determine the significance of the risk.
Risk Control
Actions
implementing risk management decisions
Periodic Reviews
Review
or monitoring of output/results of the risk management process considering (if
appropriate) new knowledge and experience about the risk.
and represents a key element of quality assurance. NEAR supports its clients to succeed this challenge.
A permanent companion within the process of deviations and changes should be the Risk Assessment representing a transparent control unit showing all posible effects on product quality and the consumer needs.
Analysing the huge amount of regulations, guidelines and standards in the IT Environment and clarifying the needs for ones’ company requires experienced, non-committed and independent experts. NEAR supports its clients with this expertise.
Computerized Systems Validation combines the strictly documented process of assuring the considered system working properly at any time and validating its process steps through all stages of development.
NEAR AG
Consulting in Life Science
Rigiweg 2
6354 Vitznau
Switzerland
Phone: +49 (0) 177 40 42 430
Email: info@near.ch