Embed Size (px)
Citation preview
Stability System ScienTek Software, Inc.
STABILITY SYSTEMCelebrating 25 Years of Innovation and Excellence.
1983 - 2008!
www.StabilitySystem.com
Stability System ScienTek Software, Inc.
What STABILITY SYSTEM does
• Database Management
Stability System ScienTek Software, Inc.
What STABILITY SYSTEM does
• Database Management• Test Scheduling
Stability System ScienTek Software, Inc.
What STABILITY SYSTEM does
• Database Management• Test Scheduling• Statistical Data Analysis
Stability System ScienTek Software, Inc.
What STABILITY SYSTEM does
• Database Management• Test Scheduling• Statistical Data Analysis• Graphics
Stability System ScienTek Software, Inc.
What STABILITY SYSTEM does
• Database Management• Test Scheduling• Statistical Data Analysis• Graphics• Sample Management
Stability System ScienTek Software, Inc.
What STABILITY SYSTEM does
• Database Management• Test Scheduling• Statistical Data Analysis• Graphics• Sample Management• Label Printing
Stability System ScienTek Software, Inc.
A Few Highlights
• Customizable Database Configuration
Stability System ScienTek Software, Inc.
A Few Highlights
• Customizable Database Configuration• 21 CFR Part 11 Compliant
Stability System ScienTek Software, Inc.
A Few Highlights
• Customizable Database Configuration• 21 CFR Part 11 Compliant• On-Screen OOS Data Checking and Flagging
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
Stability System ScienTek Software, Inc.
Statistical Data Analysis
• Expiry Dating Calculation
Stability System ScienTek Software, Inc.
Statistical Data Analysis
• Expiry Dating Calculation• Arrhenius Treatment
Stability System ScienTek Software, Inc.
Statistical Data Analysis
• Expiry Dating Calculation• Arrhenius Treatment• Poolability Test
Stability System ScienTek Software, Inc.
Statistical Data Analysis
• Expiry Dating Calculation• Arrhenius Treatment• Poolability Test• Data Pooling
Stability System ScienTek Software, Inc.
Statistical Data Analysis
• Expiry Dating Calculation• Arrhenius Treatment• Poolability Test• Data Pooling• Expiry Dating Simulation
Stability System ScienTek Software, Inc.
Database Structure
Bulk Solution in Tank - Lot # 1000
Stability System ScienTek Software, Inc.
Database Structure
Bulk Solution in Tank - Lot # 1000
PackagingType A B
Stability System ScienTek Software, Inc.
Database Structure
Bulk Solution in Tank - Lot # 1000
PackagingType
Storage Condition
A B
RT 40C RT 40C
Stability System ScienTek Software, Inc.
Database Structure
Bulk Solution in Tank - Lot # 1000
PackagingType
Storage Condition
Stability System Files
A B
RT 40C RT 40C
1000A.RT 1000A.40
1000B.RT 1000B.40
Stability System ScienTek Software, Inc.
Database Structure
Bulk Solution in Tank - Lot # 1000
PackagingType
Storage Condition
Stability System Files
Each file is theconstruction unitof the database.
All informationfor this stability
study is containedin this file.
A B
RT 40C RT 40C
1000A.RT 1000A.40
1000B.RT 1000B.40
Stability System ScienTek Software, Inc.
Content of A Stability File• Study ID (User-definable Field Information)
Stability System ScienTek Software, Inc.
Content of A Stability File• Study ID (User-definable Field Information)
• Test Schedule
Stability System ScienTek Software, Inc.
Content of A Stability File• Study ID (User-definable Field Information)
• Test Schedule
• Stability Data
Stability System ScienTek Software, Inc.
Content of A Stability File• Study ID (User-definable Field Information)
• Test Schedule
• Stability Data
• Test Specifications
Stability System ScienTek Software, Inc.
Content of A Stability File• Study ID (User-definable Field Information)
• Test Schedule
• Stability Data
• Test Specifications
• Notes
Stability System ScienTek Software, Inc.
Information
Flow
Within
STABILITY SYSTEMWorking Environment
Stability System ScienTek Software, Inc.
Stability System
Database
Stability System ScienTek Software, Inc.
Stability System
Database
TestScheduling
>> Test scheduling function scans the database and informs you tests to be performed.
Stability System ScienTek Software, Inc.
Stability System
Database
TestScheduling
Test List
>> Test list is the report generated by the Test Scheduling function.
Stability System ScienTek Software, Inc.
Stability System
Database
TestScheduling
Test List
BlankReportForm
>> Once the Test List is generated, Blank Report Forms can be generated and sent tothe performing laboratories along with the stability samples. The Blank Report Formsinform the laboratories tests to be performed along with specs and test methods.
Stability System ScienTek Software, Inc.
Stability System
Database
TestScheduling
Test List
BlankReportForm
Data Entry
>> Once stability results are generated, they can be entered by authorized personnel.
Stability System ScienTek Software, Inc.
Stability System
Database
TestScheduling
Test List
BlankReportForm
Data Entry
New DataIn Holding
File
>> Newly entered test results are not registered directly into the database. Theyare stored in the holding file first.
Stability System ScienTek Software, Inc.
Stability System
Database
TestScheduling
Test List
BlankReportForm
Data Entry
New DataIn Holding
File
Check &Approve Data
>> Test results in the holding file need to be checked and approved by authorized personnelother than those who entered the test results.
Stability System ScienTek Software, Inc.
Stability System
Database
TestScheduling
Test List
BlankReportForm
Data Entry
New DataIn Holding
File
Check &Approve Data
Merge Approved
Data
>> Finally, checked and approved test results are merged into the database.
Stability System ScienTek Software, Inc.
Stability System
Database
TestScheduling
Test List
BlankReportForm
Data Entry
New DataIn Holding
File
Check &Approve Data
Merge Approved
Data
Pending Assay List
>> STABILITY SYSTEM maintains a Pending Assay List which is constantly andcontinuously updated. Pending Assay List allows you to generate a late list.
