Good Computer Validation Practices: Common Sense Implementation - Rilegato

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

Rilegato

ISBN 10: 0935184554 ISBN 13: 9780935184556

Casa editrice: CRC Press, 1994

Riassunto

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.

Su questo libro

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

Dettagli dell?edizione

• 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