Stability Information Management

STABILITY SYSTEM provides many outstanding features to manage your stability information:

　
Feature Description
Comprehensive stability information management STABILITY SYSTEM keeps track of:
  1. study identification information
  2. test schedule/protocol
  3. test specification
  4. stability data
  5. formulation
  6. notes
FDA recommended data table format Multiple formats to suit your needs. Other formats are also available. Click here for examples.
OOS (Out-Of-Specification) data checking
  1. The OOS data is flagged on the screen when it is entered and reviewed. It can also be flagged in the hardcopy report.
  2. OOS checks can be quickly performed on the entire database or a portion of the database. A great tool for reviewing.
OOT (Out-Of-Trend) data checking This is a great method to find out the abnormal data at the earliest possible stage. OOT data checking compares the current data with the data from the previous time point against a user-specified threshold value.
On-screen checking for ICH 5% significant change A 5% potency loss is one of parameters that is treated as a significant change in the ICH stability guidelines.　
Quickly initiate new studies The information of an existing stability study can be used as a template.　
Flexible database search Allows users to find information quickly and thoroughly.　
Ultimate test specification management Test specification is unique to each stability study. Different studies for the same product can have different test specification. Test specifications can be edited on the product basis or based on a database search.　
Pre-defined pick-list terms for study identification fields Most user-defined study identification fields can have pick-list terms to assist in information entry and standardize terminology to assist in database searches. Click here for an example.
User-customizable study identification fields Database field definition can be customized to meet the user's requirement. You will continue to use your terminology.
Handle multiple data Enter and store multiple individual data; the system will compute and store user-specified statistical parameters (mean, range, standard deviation or relative standard deviation).　
Import data Import foreign data into STABILITY SYSTEM database via CSV (Comma Separated Value) files.　
Export information
  1. Export stability information as CSV (Comma Separated Value) files
  2. Export database information as HTML files
  3. Export database information via Windows Clipboard
Generate data tables suitable for electronic submission Generating PDF files cannot be any easier. The data tables are based on the FDA's recommendations for the PDF file format
Built-in USP dissolution criteria table STABILITY SYSTEM makes all decisions for you based on the individual dissolution data. STABILITY SYSTEM keeps all individual dissolution data and, optionally, the computed statistical parameters (mean, range, SD or RSD) in the database.　
Plot dissolution profiles Plot dissolution profiles for extended-release dosage forms.　
Ability to generate COA (Certificate Of Analysis) for a selected time point.　 A great feature for contract houses.
Multiple levels of data checking The incoming new data is stored in a holding file first. The data must be checked, then approved, and finally merged into the database.　
Internal specifications When the internal (warning) specification is available, the data is also checked against it.　
Alternate test specifications A great function if a product is marketed with different product specifications. The alternate specifications can be incorporated into data tables.
Specify pick-list terms for stability results in selected tests This is a great way to standardize terminology and assist in the data entry. Click here for an example.
Generate HTML files Sharing the stability information with others made easy with HTML files, which can be generated from the entire database or a portion of the database.　
Generate study summary Great for protocol reviewing.　
Generate database summary table Can also include test progress information.　
Product formulation information The formulation information can be incorporated into the data table. Click here for an example.
Built-in database engine No need to purchase and implement a separate database.　
Can be managed by stability professionals Minimum involvement of IT personnel.　
Database occupies tiny disk space Full power with minimum hardware resources. Click here for more information.
Review recently entered new data Allow personnel who are more remotely involved in the daily maintenance of the STABILITY SYSTEM database to review the new data that are recently entered, checked, approved and merged into the database.　
Archive files Archive by transferring a stability file to a designated path. Archived files can be restored into the database if needed.
Hot file list The hot file list is a list of files that are referred to repeatedly. From the hot file list, the file contents can be easily browsed. Files can also be selected from the hot file list for further processing.　
Online help information Press F1 key to display context-sensitive help information.　
Online User Manual All operating details at your fingertips.