Risk management in the pharmaceutical and medical technology with PLATO.

Risk management in the pharmaceutical and medical products that are used in and on humans, can endanger the health and life of the user / patient by misconduct or failure. The beneficial effect of a product has to be in an accepatble relationship to the potential risks. Risk management is an essential component in the development of pharmaceutical and medical products. Manufacturers are required by law to perform a risk analysis for their products.

SCIO™ supports the risk analysis of the specific requirements from the medical industry. Combined with system analysis SCIO™ provides data for the continous improvement of product design and manufacturing processes.

PLATO's software solutions are focused on the integration of existing systems (document management, records management, action management, audit management, etc.) in a solution-based platform in a strategic market for PLATO.

As a condition for the marketing of medical devices, which is determined in the international guidelines, they must meet basic requirements to ensure proper performance of medical devices and the safety of patients, users and third parties.

Companies that develop by phase models must ensure that a certain set of documents will be made ​​available and evaluated by a phase transition to another.Documents based process controlling is guaranteed by the developed software of the project. The software ensures a structured and professional approach to project management
and anchored standardized project processes in the company.