SYSTEMS VALIDATION
SYSTEMS VALIDATION
OYTEC has demonstrated its ability to manage important EBR-MES implementation projects.
The deployment methodology has been designed in accordance with the GAMP 5 standards.
To meet the strict quality requirements of regulated industries, OYTEC has incorporated quality management as an integral part of project planning, basing the methodology on cGMPs validation guidelines that are applied throughout the entire cycle of project life.
The validation of the project is a phase assumed jointly by the client and the supplier.
The project validation plan is agreed at the beginning of the project, clearly defining the responsibilities of the different people, departments and companies involved in the project.
System Validation