Cantitate/Preț
Produs
Total produse
Vezi coșul
Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers de Guy Wingate

Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers

Editat de Guy Wingate
en Limba Engleză Paperback – 23 sep 2019
One of the biggest computer validation challenges facing pharmaceutical manufacturers is the large corporate system. This book provides practical information and advice on good IT practice and validation principles. Written by experts, it includes case studies on EDMSs, EAM systems, LIMSs, and MRP II systems.
Citește tot Restrânge

Toate formatele și edițiile

Toate formatele și edițiile Preț Express
Paperback (1) 54759 lei  6-8 săpt.
  CRC Press – 23 sep 2019 54759 lei  6-8 săpt.
Hardback (1) 135194 lei  6-8 săpt.
  CRC Press – 31 mai 2000 135194 lei  6-8 săpt.

Preț: 54759 lei

Preț vechi: 64422 lei
-15% Nou

Puncte Express: 821
Preț estimativ în valută:
10479€ • 10874$ • 8759£

Carte tipărită la comandă

Livrare economică 17-31 martie

 Adaugă în coș

Wish list
Gift list
Am citit!
Adaugă în listă
Preluare comenzi: 021 569.72.76

Specificații

ISBN-13: 9780367398569
ISBN-10: 0367398567
Pagini: 544
Dimensiuni: 178 x 254 x 30 mm
Greutate: 2.07 kg
Ediția:1
Editura: CRC Press
Colecția CRC Press

Public țintă

Academic and Professional Practice & Development

Cuprins

Paperless & Peopleless Plants. Developing an Information System Strategy. Regulatory Expectations. IT Validation Policy. GxP Compliance. Integrating Manufacturing Systems. Validating Asset Management Systems. Validating Enterprise/Manufacturing Planning Systems. Validating Lab Information Management Systems. Validating Electronic Document Management. Compliance for IT Infrastructure. Validating Local & Wide Area Networks. Maintenance & Support of IT Systems. Auditing Suppliers. Auditing Software Integrators & Hardware Manufacturers. Practical Implications of Electronic Signatures & Records. 21st Century Validation.

Descriere

Written by experts, this book provides authoritative information and practical advice on validating corporate computer systems. It covers good IT practice and validation principles and presents case studies on EDMSs, EAM systems, LIMSs, and MRP II systems. Topics include the increasing role of IT systems within the modern pharmaceutical manufacturing plant and the move toward paperless manufacturing, how to develop an information strategy, the importance of demonstrating regulatory compliance, how to maintain validated systems, conduct supplier audits for software packages, hardware manufacturers, and software integrators, the practical implications of 21 CFR 11, and more.