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Sistemas de gestión de ensayos clínicos

Seguridad en los ensayos clínicos

Los sistemas de gestión de ensayos clinicos manejan una gran cantidad de datos que se utilizarán para demostrar la eficacia y seguridad de los medicamentos.
Los resultados obtenidos despues de la elaboración de los datos en los estudios clinicos se utilizarán para la aprobación del nuevo medicamento.
La seguridad de los proceso de almacenamiento, análisis e impresión de estos datos requiere validación.

SEV dispone de profesionales con amplia experiencia de validación de sistemas de gestión de ensayos clínicos.


Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.

21 CFR Part 211, Sec 211.63

Validation should be considered as part of the complete life cycle of a computer system. This cycle includes the stages of planning, specification, programming, testing, commissioning, documentation, operation, monitoring and modifying.

EU GMP, Annex 11, Computerized Systems

The manufacturer shall establish and implement an effective pharmaceutical quality assurance system, involving the active participation of the management and personnel of the different departments.


It is a requirement of GMP that manufacturers identify what validation work is needed to prove control of the critical aspects of their particular operations. Significant changes to the facilities, the equipment and the processes, which may affect the quality of the product, should be validated. A risk assessment approach should be used to determine the scope and extent of validation.

EU GMP, Annex 15, Qualification and validation