BMTW-SVN01F-EN 237
Appendix C
Tracer Summit Critical
Control System
The Critical Control System is designed to meet FDA CFR part 11
requirements. The system retains certain critical data in the audit trail
database which is maintained by the SQL Database server. Because the
SQL database server acquires the data from the PC workstations it is rec-
ommended that at least two PC workstations be continuously in opera-
tion to prevent gaps in the audit trail.
SQL Database Server Requirements
The minimum requirements for the PC running the Microsoft SQL Data-
base server are:
• Windows 2000 Server
• Microsoft SQL 2000 (standard or enterprise) database
• 1 GHz processor with a 512 cache
• 1 GB RAM
• two 36 GB SCSI hard drives
• Raid1 Parity system
• UPS
PC Workstation Requirements
The minimum requirements for a PC Workstation running Tracer Sum-
mit Critical Control System software are:
• Windows XP Professional operating system
• 1 GHz processor with a 512k cache
• 512 MB RAM
• 20 GB hard drive storage
• 8X CD-ROM to run the Tracer Summit Daily Operations Tutorial
• 15-inch SVGA monitor, 800 × 600 resolution, 16-bit color
• Mouse
• Keyboard
Note:
The Tracer 100/Tracker communication feature and the Multi-
site, Grouping, and Global Change Control feature of Tracer
Summit are not available with the Critical Control System.
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