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eSTAR - Electronic Stability Testing Analyses & Reporting

To meet the stability requirements set forth by FDA; EAPHARMICS has developed the eSTAR Stability System software package that handles all the requirements of a full-scale stability program. Sample management, report generation, and statistical evaluations are made available through an intuitive user interface that allows both experienced and occasional user the same level of comfort. The system also maintains multilevel security that ensures 21 CFR part 11 compliance.
Login New Studies

Once the system maintenance modules are used to define the user access and the dictionaries, respectively sample login can be initiated.

Quickly define studies using new study login module

Define packaging
Manufacturing information
Manufacturing site and packaging site
Raw material lots
Study conditions
Reason for study
Testing dates and intervals
Protocols
Label requests
Stability Maintenance Modules
Enter unlimited records in defined dictionaries.
Create Product, Tests, Intervals and Protocols in specification library to be used in New Study Login
Different level of approval for Products can be set through administration area in system maintenance modules
Package Dictionaries
Specification Library
Setup several other dictionaries.
Data Access Evaluation Modules

After the data has been approved, dynamic interactive multiple graphics can be generated with following options:
Graphics Generator
Single Product Evaluation By Year
Multiple Product Evaluation
Sample to Sample Comparison
Parameter Overlay
Expiration Single Study
Expiration Multiple Studies

These graphics can be viewed as Line, Bar, Area, Pie, Plot, Bubble and HLOC Charts. The graphics are interactive and use can dynamically change the look and feel with the power of Rich Internet Application Interface.

Generate the PDF with graph, data and user notes
Data Entry Modules
As test results are generated in the laboratory the results are entered into the system.
Various levels of data approval are available in the eSTAR stability system. This can be setup through administration functionality through system maintenance modules.
Different color codes are displayed according to data such as red if OOS, in blue if the result is outside the defined alert limits for the test and as purple if outside the defined variance limits for the test.
EAPHARMICS Help
Web based help system.
Explanation in detail of all modules
Contents, Index and Search tabs
Standard Eclipse Help format.
Log Manipulation Modules

After the samples have been logged into the system, test requests can be generated using the sample scheduling modules

Generate:
Pull lists for any time frame
Testing forms
Inventory request lists
Assign sample tracking numbers
Query lists for late samples
Query and sort lists using multiple criteria
Print Modules

Generate multiple reporting formats ranging from tabular and watermark options.
Print complete reports
Define standard summary report layout
Generate PDF format for any system report
Statistical evaluations and expiration dating
Schedules, forms and laboratory evaluation
Summary Report Generator
Analyst Report Generator
Database Logs
Stability Protocol Report
Certificate of Analysis
Customize label with 21 CFR part 11 compliance
Manage Labels
Label Manager
Label Request
Label Printing
System Maintenance Modules

Overlaying the entire stability system is a 21 CFR part 11 complaint security net.

System edit logs to document any changes made to study data or sample information.

System access is controlled by the system supervisor down to the module level
Limit system access
Limit module access
Password Expiration
Bilateral user ID and password identification
Access failure lock out
System access logs
Create group level privileges
21 CFR Part 11 compliant
System auto lock setup

Place Your mouse over each image for a description.

Click the image to get more detail on the Modules.