Validating Corporate Computer Systems -

Validating Corporate Computer Systems

Good IT Practice for Pharmaceutical Manufacturers

Guy Wingate (Herausgeber)

Buch | Softcover
544 Seiten
2019
CRC Press (Verlag)
978-0-367-39856-9 (ISBN)
77,30 inkl. MwSt
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.

Erscheinungsdatum
Verlagsort London
Sprache englisch
Maße 178 x 254 mm
Gewicht 2070 g
Themenwelt Mathematik / Informatik Informatik Theorie / Studium
Technik
ISBN-10 0-367-39856-7 / 0367398567
ISBN-13 978-0-367-39856-9 / 9780367398569
Zustand Neuware
Haben Sie eine Frage zum Produkt?
Mehr entdecken
aus dem Bereich
was jeder über Informatik wissen sollte

von Timm Eichstädt; Stefan Spieker

Buch | Softcover (2024)
Springer Vieweg (Verlag)
37,99
Grundlagen – Anwendungen – Perspektiven

von Matthias Homeister

Buch | Softcover (2022)
Springer Vieweg (Verlag)
34,99
Eine Einführung in die Systemtheorie

von Margot Berghaus

Buch | Softcover (2022)
UTB (Verlag)
25,00