Shimadzu TOC-V - Table of Contents

Table of Contents
vii
TOC-V
Introduction............................................................................................ iii
Product Warranty and Post Sale Service .................................................... iv
Product Warranty ............................................................................... iv
Post Sale Service ................................................................................ iv
Relevant Instruction Manuals..................................................................... iv
Contents of This Manual ............................................................................. v
Notation Conventions.................................................................................. v
Precautionary Conventions Used in this Manual ................................ v
Other Conventions Used in this Manual ............................................. v
1 Overview of GLP/GMP ........................................................................... 1
1.1 Basic Concepts of GLP/GMP...................................................................... 2
1.1.1 GLP/GMP............................................................................................ 2
1.1.2 FDA 21 CFR Part 11........................................................................... 2
2 System Administration Overview........................................................... 3
2.1 System Administration Concepts ................................................................ 4
2.1.1 System Administration Functions ....................................................... 4
2.1.2 Data Administration Flow ................................................................... 6
2.2 Explanation of System Administration Functions....................................... 7
2.2.1 Inspection of the TOC History Database ............................................ 7
2.2.2 Output and Viewing of the Data Profile.............................................. 8
2.2.3 User Authentication............................................................................. 9
3 System Administration Operations ...................................................... 11
3.1 TOC-Control V Main Menu...................................................................... 12
3.2 System Administration Tool...................................................................... 14
3.2.1 User Accounts ................................................................................... 15
3.2.2 Database Manager ............................................................................. 18
3.2.3 Program Test (S/W Validation)......................................................... 21
3.2.4 Security.............................................................................................. 22
3.2.5 External Modules .............................................................................. 28
3.2.6 Change Password .............................................................................. 29
3.2.7 Add Event Log .................................................................................. 30
3.3 Operation History ...................................................................................... 31
3.4 Data Profile................................................................................................ 34
3.5 Sample Table Editor .................................................................................. 38