STABLIMS

User guide
Installation guide
CFR Part 11 Guide
User requirements specifications (URS)
Functional and design specifications (FRS)
IQ/OQ/PQ Validation protocols

YOUR PACKAGE CONTAINS:

• STATE OF CONTROL INCREASED  EFFICIENCY:

  Setting of Testing Intervals with each orientation
  Orientation of the sample
  Chamber of storage suitable for all stability zones
  Testing Intervals
  Tolerance period for retrieval of samples and testing (Samples past this tolerance period trigger a chain of alerts)
  Stability study Protocol
  The testing frequency for each product
  Storage conditions for each study
  Container closure system description
  Testing to be performed at each time point
  Out of specification investigations:
  Investigation detail contains additional information regarding each investigation such as the reason, action, follow-up and final decision.
  The Investigation Master list holds all the investigations, their status, expiry and other information that can be used to filter the list.
  Stability Chamber Excursion Investigation Form
  Trending:
  Linear regression is available to approximate the shelf life. % for the confidence levels can be chosen. Lots may be trended one at a time or multiple lots for the same product trended together as one regression line or
  The same data can be viewed in a Scatter Plot
  Multiple studies may be used to approximate the shelf life of a new study using the Arrhenius equation.
  The Free Query is a data mining tool that allows one to query on any data input in the Stability Program. Automatic reports can then be set up and generated. Queries can be saved for future use. Also, a bar or line chart is available for the chosen data.
  All reports can be exported to a variety of different applications including Microsoft Word, Excel and outlook. In addition, the free format query can allow you to retrieve and report information as needed.

  APPLICATION FEATURES:
  
  Multiple user levels in which The System Administrator manages user authorities; determining the number of Login Retries, and the password expiration time with defined user rights within the system.
  A full independent audit trail includes user log and change control that tracks and stores all entries made in the system
  Work Schedules provide print outs of the entire workload, and can be fully filtered. For example: by product, or by different users and their respective tasks
  Automatically generates work schedules with printable detailed information
  Color coded sample status for easy viewing and Additional notifications include automated emails.
  Calculation methods fitting for all analytical analysis associated with printable worksheets include all calculations.
  Tailored labels adopted with the customer policy generation for all situations.
  Contractor evaluation process depending on ability for solving the problems and rabidity of response.
  Estimated costs of stability studies are calculated
  Inventory System is built in to keep track of sample activity either by product or by location, offers a location view of samples, and allows for the transfer of samples from one location to another.
  Product Registration which include:
  Name, Packaging Lot number and Format
  Specification (It also tracks the number of significant digits for each test)

  HANDLING INCREASED ACCURACY:

  BENEFITS:

Enterprise Stability Module