| Item |
Description |
| Name of software |
KF-Win/ER : FDA 21 CFR Part 11 Compliant
Software for Karl Fischer Moisture Titrator |
FDA 21 CFR Part 11
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 |
|
| 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 fanction |
| • |
|
Direct backup recording in CD-R or other
device |
| • |
|
Backup data can be viewed directly |
|
| GLP/GMP compliant features |
| • |
|
Check with standard substances |
| • |
|
Notify Periodic
calibration/check/validation |
| • |
|
Auto recording of the results of
calibration/check/validation in database |
|
| Network link |
Interface to the Shimadzu CLASS-Agent System |
| Compatible modeles |
MKA-510N, MKS-510N and MKC-510N |
