Buch, Englisch, 544 Seiten, Format (B × H): 183 mm x 260 mm, Gewicht: 1210 g
Good IT Practice for Pharmaceutical Manufacturers
Buch, Englisch, 544 Seiten, Format (B × H): 183 mm x 260 mm, Gewicht: 1210 g
ISBN: 978-1-57491-117-6
Verlag: CRC Press
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.
Zielgruppe
Academic and Professional Practice & Development
Autoren/Hrsg.
Fachgebiete
Weitere Infos & Material
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.




