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Sistemas de Gestión Documental


 
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Los sistemas de gestión documental permiten estandarizar el proceso de desarrollo, revisión y aprobación de la toda la documentación de los laboratorios farmacéuticos.
Muchos de los requerimientos normativos asociados con la gestión documental están controlados por el sistema informático:
- Control del ciclo de revisión y aprobación de la documentación;
- Control de la correcta distribución de los procedimientos;
- Gestión de la impresión y de las copias controladas;
- Gestión de las versiones de los documentos;
Por este motivo los sistemas de gestión documental necesitan ser validados.
SEV dispone de profesionales con amplia experiencia en la validación de los sistemas más difundidos del 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