1. Celebrating 25 Years of Innovation and Excellence.
STABILITY SYSTEM
Celebrating 25 Years of Innovation and Excellence. !
Stability System ScienTek Software, Inc.

2. What STABILITY SYSTEM does
Database Management
Stability System ScienTek Software, Inc.

3. What STABILITY SYSTEM does
Database Management
Test Scheduling
Stability System ScienTek Software, Inc.

4. What STABILITY SYSTEM does
Database Management
Test Scheduling
Statistical Data Analysis
Stability System ScienTek Software, Inc.

5. What STABILITY SYSTEM does
Database Management
Test Scheduling
Statistical Data Analysis
Graphics
Stability System ScienTek Software, Inc.

6. What STABILITY SYSTEM does
Database Management
Test Scheduling
Statistical Data Analysis
Graphics
Sample Management
Stability System ScienTek Software, Inc.

7. What STABILITY SYSTEM does
Database Management
Test Scheduling
Statistical Data Analysis
Graphics
Sample Management
Label Printing
Stability System ScienTek Software, Inc.

8. A Few Highlights Customizable Database Configuration
Stability System ScienTek Software, Inc.

9. A Few Highlights Customizable Database Configuration
21 CFR Part 11 Compliant
Stability System ScienTek Software, Inc.

10. A Few Highlights Customizable Database Configuration
21 CFR Part 11 Compliant
On-Screen OOS Data Checking and Flagging
Stability System ScienTek Software, Inc.

11. A Few Highlights Customizable Database Configuration
21 CFR Part 11 Compliant
On-Screen OOS Data Checking and Flagging
Windows-Based and User-Friendly
Stability System ScienTek Software, Inc.

12. Statistical Data Analysis
Expiry Dating Calculation
Stability System ScienTek Software, Inc.

13. Statistical Data Analysis
Expiry Dating Calculation
Arrhenius Treatment
Stability System ScienTek Software, Inc.

14. Statistical Data Analysis
Expiry Dating Calculation
Arrhenius Treatment
Poolability Test
Stability System ScienTek Software, Inc.

15. Statistical Data Analysis
Expiry Dating Calculation
Arrhenius Treatment
Poolability Test
Data Pooling
Stability System ScienTek Software, Inc.

16. Statistical Data Analysis
Expiry Dating Calculation
Arrhenius Treatment
Poolability Test
Data Pooling
Expiry Dating Simulation
Stability System ScienTek Software, Inc.

17. Bulk Solution in Tank - Lot # 1000
Database Structure
Bulk Solution in Tank - Lot # 1000
Stability System ScienTek Software, Inc.

18. Bulk Solution in Tank - Lot # 1000
Database Structure
Bulk Solution in Tank - Lot # 1000
Packaging
Type A B
Stability System ScienTek Software, Inc.

19. Bulk Solution in Tank - Lot # 1000
Database Structure
Bulk Solution in Tank - Lot # 1000
Packaging
Type A B
Storage
Condition RT
40C RT
40C
Stability System ScienTek Software, Inc.

20. Bulk Solution in Tank - Lot # 1000
Database Structure
Bulk Solution in Tank - Lot # 1000
Packaging
Type A B
Storage
Condition RT
40C RT
40C
Stability
System
Files
1000A.RT
1000A.40
1000B.RT
1000B.40
Stability System ScienTek Software, Inc.

21. Bulk Solution in Tank - Lot # 1000
Database Structure
Bulk Solution in Tank - Lot # 1000
Packaging
Type A B
Each file is the
construction unit
of the database.
All information
for this stability
study is contained
in this file.
Storage
Condition RT
40C RT
40C
Stability
System
Files
1000A.RT
1000A.40
1000B.RT
1000B.40
Stability System ScienTek Software, Inc.

22. Content of A Stability File
Study ID (User-definable Field Information)
Stability System ScienTek Software, Inc.

23. Content of A Stability File
Study ID (User-definable Field Information)
Test Schedule
Stability System ScienTek Software, Inc.

24. Content of A Stability File
Study ID (User-definable Field Information)
Test Schedule
Stability Data
Stability System ScienTek Software, Inc.

25. Content of A Stability File
Study ID (User-definable Field Information)
Test Schedule
Stability Data
Test Specifications
Stability System ScienTek Software, Inc.

26. Content of A Stability File
Study ID (User-definable Field Information)
Test Schedule
Stability Data
Test Specifications
Notes
Stability System ScienTek Software, Inc.

27. STABILITY SYSTEM Information Flow Within Working Environment
Stability System ScienTek Software, Inc.

28. Stability
System
Database
Stability System ScienTek Software, Inc.

29. Stability System Database Test Scheduling
>> Test scheduling function scans the database and informs you tests to be performed.
Stability
System
Database
Test
Scheduling
Stability System ScienTek Software, Inc.

30. Stability System Database Test Scheduling Test List
>> Test list is the report generated by the Test Scheduling function.
Stability
System
Database
Test
Scheduling
Test List
Stability System ScienTek Software, Inc.

31. Stability System Database Test Scheduling Test List Blank Report Form
>> Once the Test List is generated, Blank Report Forms can be generated and sent to
the performing laboratories along with the stability samples. The Blank Report Forms
inform the laboratories tests to be performed along with specs and test methods.
Stability
System
Database
Test
Scheduling
Test List
Blank
Report
Form
Stability System ScienTek Software, Inc.

32. Stability System ScienTek Software, Inc.
>> Once stability results are generated, they can be entered by authorized personnel.
Stability
System
Database
Test
Scheduling
Test List
Blank
Report
Form
Data Entry
Stability System ScienTek Software, Inc.

33. Stability System ScienTek Software, Inc.
>> Newly entered test results are not registered directly into the database. They
are stored in the holding file first.
Stability
System
Database
Test
Scheduling
Test List
Blank
Report
Form
Data Entry
New Data
In Holding
File
Stability System ScienTek Software, Inc.

34. Stability System ScienTek Software, Inc.
>> Test results in the holding file need to be checked and approved by authorized personnel
other than those who entered the test results.
Stability
System
Database
Test
Scheduling
Test List
Blank
Report
Form
Data Entry
Check &
Approve Data
New Data
In Holding
File
Stability System ScienTek Software, Inc.

35. Stability System ScienTek Software, Inc.
>> Finally, checked and approved test results are merged into the database.
Stability
System
Database
Test
Scheduling
Test List
Blank
Report
Form
Data Entry
Merge
Approved
Data
Check &
Approve Data
New Data
In Holding
File
Stability System ScienTek Software, Inc.

36. Stability System ScienTek Software, Inc.
>> STABILITY SYSTEM maintains a Pending Assay List which is constantly and
continuously updated. Pending Assay List allows you to generate a late list.
Stability
System
Database
Test
Scheduling
Test List
Blank
Report
Form
Pending
Assay List
Data Entry
Merge
Approved
Data
Check &
Approve Data
New Data
In Holding
File
Stability System ScienTek Software, Inc.