Validating Corporate Computer Systems

Good IT Practice for Pharmaceutical Manufacturers
Herausgeber: Wingate, Guy

• Gebundenes Buch

Produktbeschreibung

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.

Produktdetails

• Verlag: Taylor & Francis Ltd (Sales)
• Seitenzahl: 544
• Erscheinungstermin: 31. Mai 2000
• Englisch
• Abmessung: 266mm x 180mm x 40mm
• Gewicht: 1306g
• ISBN-13: 9781574911176
• ISBN-10: 1574911171
• Artikelnr.: 23528950

Autorenporträt

Guy Wingate

Inhaltsangabe

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.