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Installation Qualification of IBM Systems and Storage for FDA Regulated Companies
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This IBM Redbook contains an Installation Qualification (IQ) executed at a pharmaceutical manufacturer with the help of IBM. The customer purchased IBM equipment to support a major new computerized system that came within the regulatory scope of FDA 21 CFR Part 11. This IQ was performed as one part of an overall systems validation, and a separate system requirements document contained the technical infrastructure requirements, including equipment.
The following IBM equipment was installed and qualified by the customer for this project:
IBM eServer pSeries 670 Server running AIX, HACMP, LPARs
IBM TotalStorage Enterprise Storage Server
IBM LTO Tape Library
IBM McData SAN Switches
The materials contained in this Installation Qualification include:
Protocol
Procedures
Training materials
Test scripts for the IBM equipment
Price:
$62.50
$50.00
Pages:
454
Date Published:
September 9, 2003
ISBN:
0738454117
Author:
IBM Redbooks
Product Number:
SG24-6630-00
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