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Sistemas de Gestión


 
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Los sistemas de gestión son sistemas de información gerenciales que integran y manejan muchos de los negocios asociados con las operaciones de producción y de los aspectos de distribución de una compañía.
Entre ellos pueden distinguirse categorías de sistemas como:
- ERP: planificación de recursos empresariales
- MES: sistemas de ejecución de la fabricación
- MRP: sistemas de planificación de recursos
Estos sistemas habitualmente manejan datos relevantes para las normativas GMP, y por eso necesitan de validación.

SEV dispone de profesionales con amplia experiencia de validación de los sistemas mas difundidos en el mercado.

Referencias

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.

COMMISSION DIRECTIVE 2003/94/EC, Article 6

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