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Stability System ScienTek Software, Inc. STABILITY SYSTEM Celebrating 25 Years of Innovation and Excellence. 1983 - 2008! www.StabilitySystem.com.

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Presentation on theme: "Stability System ScienTek Software, Inc. STABILITY SYSTEM Celebrating 25 Years of Innovation and Excellence. 1983 - 2008! www.StabilitySystem.com."— Presentation transcript:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

19 Stability System ScienTek Software, Inc. Database Structure Bulk Solution in Tank - Lot # 1000 Packaging Type Storage Condition AB RT40CRT40C

20 Stability System ScienTek Software, Inc. Database Structure Bulk Solution in Tank - Lot # 1000 Packaging Type Storage Condition Stability System Files AB RT40CRT40C 1000A.RT1000A B.RT1000B.40

21 Stability System ScienTek Software, Inc. Database Structure Bulk Solution in Tank - Lot # 1000 Packaging Type Storage Condition Stability System Files Each file is the construction unit of the database. All information for this stability study is contained in this file. AB RT40CRT40C 1000A.RT1000A B.RT1000B.40

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

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

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

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

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

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

28 Stability System ScienTek Software, Inc. Stability System Database

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

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

31 Stability System ScienTek Software, Inc. 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.

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

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

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

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

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


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