| Item |
Description |
| Name of software |
AT-Win/ER ,FDA 21 CER Part11 Compliant
Software |
FDA 21 CFR Part11
compliant features |
User authentication |
Login ID and Password security
User name and title registration
Group management for up to 11 user groups
Password valid period
Detection of illegal access and lockout (access number counting and its time
length) |
| Electronic signatures |
Signatures according to users’
authentication
Verified data is stored in database with comments |
| Data integrity |
Auto recording raw data and meta data in
database
Auto recording measurement parameters and results
(Database: compatible with the Microsoft SQL Server/MSDE, Oracle)
Can see stored and compressed data with Viewer |
| Audit trail |
Record created or changed Methods with
comments
Auto recording of results and re-evaluated data with all changes noted.
Search the recorded data |
| Backup function |
Direct backup recording in CD-R or other
device
Backup data can be viewed directly. |
| GLP/GMP compliant features |
Electrode calibration/Check with standard
substances/Validation of burette dosing volume
Notify Periodic calibration/check/validation (by setting date or its
interval)
Auto recording of the results of calibration/check/validation in database |
| Network link |
Interface to the Shimadzu CLASS-Agent
System |
| Compatible models |
AT-510 and AT-500N |
