Installation Qualification of IBM Systems and Storage for FDA Regulated Companies

IBM Redbooks

Installation Qualification of IBM Systems and Storage for FDA Regulated Companies

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
Pages: 454
Date Published: September 9, 2003
ISBN: 0738454117
Author: IBM Redbooks
Product Number: SG24-6630-00
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