Validating Corporate Computer Systems

Good IT Practice for Pharmaceutical Manufacturers

Buch | Hardcover

544 Seiten

2000
Crc Press Inc (Verlag)
978-1-57491-117-6 (ISBN)

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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.

Guy Wingate

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.

Erscheint lt. Verlag	31.5.2000
Verlagsort	Bosa Roca
Sprache	englisch
Maße	178 x 254 mm
Gewicht	1170 g
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Laboratoriumsmedizin
	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
	Naturwissenschaften ► Biologie
	Technik
ISBN-10	1-57491-117-1 / 1574911171
ISBN-13	978-1-57491-117-6 / 9781574911176
Zustand	Neuware