Good Computer Validation Practices: Common Sense Implementation - Rilegato

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

 
9780935184556: Good Computer Validation Practices: Common Sense Implementation
Rilegato
ISBN 10: 0935184554 ISBN 13: 9780935184556
Casa editrice: CRC Press, 1994

Sinossi

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.

Le informazioni nella sezione "Riassunto" possono far riferimento a edizioni diverse di questo titolo.

Contenuti

Chapters cover:
o Computer Validation Projects, Problems & Solutions
o International Regulations & Computer Systems
o Role of Senior Management
o Documentation Practices & Principles
o Validation Concepts & Terminology
o Existing Computer Systems: Retrospective Evaluation
o Data Center Management & Good Practices
o Audit of External Software Vendors
o Clinical Data Systems, GCP Validation & CANDA
o Computerized Systems Validation: Preparation for an FDA
Bioprocess Inspection

Le informazioni nella sezione "Su questo libro" possono far riferimento a edizioni diverse di questo titolo.

Editore
CRC Press
Data di pubblicazione
1994
Lingua
Inglese
ISBN 10 
0935184554
ISBN 13 
9780935184556
Rilegatura
Copertina rigida
Numero edizione
1
Numero di pagine
336
Contatto del produttore
non disponibile
Persona responsabile
non disponibile