Good Computer Validation Practices: Common Sense Implementation - Couverture rigide

Stokes, Teri; Branning, Ronald C.; Chapman, Kenneth G.; Hambloch, Heinrich; Trill, Anthony J.

 
9780935184556: Good Computer Validation Practices: Common Sense Implementation
Couverture rigide
ISBN 10 : 0935184554 ISBN 13 : 9780935184556
Editeur : CRC Press Inc, 1994

Synopsis

This sensible text on computer systems validation examines the regulatory and practical issues of computer validation from a global perspective and provides a common-sense approach to getting the job done. Combining the insights of an internationally respected group of computer systems specialists, healthcare industry professionals, and a regulator, it provides SOPs, checklists, and tips to make global computer validation an obtainable goal. Topics and concerns detailed in the text span the breadth of issues and influences imposed upon computer validation by worldwide GCP, GLP, and GMP requirements and provide an approach that meets the regulatory and real-world needs of the healthcare manufacturing and research industries.

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

Présentation de l'éditeur

This sensible text on computer systems validation examines the regulatory and practical issues of computer validation from a global perspective and provides a common-sense approach to getting the job done. Combining the insights of an internationally respected group of computer systems specialists, healthcare industry professionals, and a regulator, it provides SOPs, checklists, and tips to make global computer validation an obtainable goal. Topics and concerns detailed in the text span the breadth of issues and influences imposed upon computer validation by worldwide GCP, GLP, and GMP requirements and provide an approach that meets the regulatory and real-world needs of the healthcare manufacturing and research industries.

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

Éditeur
CRC Press Inc
Date d'édition
1994
Langue
anglais
ISBN 10 
0935184554
ISBN 13 
9780935184556
Reliure
Relié
Nombre de pages
336
Coordonnées du fabricant
non disponible
Personne responsable
non disponible