Validating Corporate Computer Systems

NOTE EDITORE

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.

SOMMARIO

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.

AUTORE

Guy Wingate

ALTRE INFORMAZIONI

• Condizione: Nuovo
• ISBN: 9781574911176
• Dimensioni: 10 x 7 in Ø 2.45 lb
• Formato: Copertina rigida
• Pagine Arabe: 544