Management of IT processes
Managing IT processes has become a major stake in corporate governance. The largest organisations working with IT processes (SEI, ISACA, PMI, IEEE, etc.) have defined their standards and good practices. With its experts and GXPMANAGER tool, CVO-EUROPE offers you innovative solutions to optimise your management of IT processes.
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Quality Management System (QMS)
- Quality Management System (QMS):
- Definition of the Quality Policy, the organisation to be implemented and related responsibilities;
- The installation of a QMS in conformity with GxP regulations (GMP, GLP, GCP, GDP) and/or ISO standards (ISO 9001, 13485, 17025, 14001, etc.);
- Integration of ICH Q10 requirements (Pharmaceutical Quality System) for pharmaceutical operations;
- Modelling and evaluating processes then proposing an improvement plan;
- Implementing quality related risk management methodology (ICH Q9);
- Setting up a QA department (CVO-EUROPE) or reinforcing an internal QA department (client).
Documentation
- Setting up and optimising the structure of documentation.
- Drafting or improving the quality manual.
- Drafting and updating procedures, operating procedures and work instructions.
- Evaluating documentation / regulations.
Continuous improvement of quality management procedures
- Improving quality and performance, and reducing costs.