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Validation of chromatography data systems : meeting business and regulatory requirements /
Chromatography is a major analytical technique that is used throughout research, development and manufacturing in the pharmaceutical, medical device and associated industries. To demonstrate fitness for purpose with the applicable regulations, the systems must be validated. Validation of Chromatogra...
| Clasificación: | Libro Electrónico |
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| Autor principal: | |
| Autor Corporativo: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Cambridge :
Royal Society of Chemistry,
©2005.
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| Colección: | RSC chromatography monographs.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Introduction to chromatography data systems
- Regulatory requirements for CDS validation
- Concepts of computer validation
- CDS validation : managing system risk
- Process redesign to exploit the tangible benefits of electronic signatures with a CDS
- Writing the user requirements specification
- Controlling the work : the validation plan
- System selection
- Auditing the CDS vendor
- Contract, purchase order and planning the installation
- Risk assessment and requirements traceability
- Installation qualification and operational qualification
- Performance qualification (PQ) or end-user testing
- User training and system documentation
- IT support of the system
- System description
- Validation summary report
- Defining electronic records for a CDS
- Maintaining the validation status during operational life
- Periodic review of the CDS
- Records retention
- CDS data migration
- CDS system retirement
- Retrospective validation.