//Stability Study Management
Stability Study Management 2017-05-24T10:20:56+00:00
Stability Study Management

Stability Study Management

The complete solution for managing Pharmaceutical Stability testing

Matrix Gemini Stability provides a stability management system for complete control of stability studies for a variety of industries. This includes creation of the stability protocol with its various notes, required fields and imported documents. Under a study protocol the user defines the “batches” or “lots” associated with that study. A batch then contains a pull schedule, tests, conditions, cycles and test specifications specific to the protocol.

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Stability Study Management Overview

Stability Study Protocol
  • Create new stability protocols, or copy from an existing study template
  • Approve the protocol then start the study
  • Confirm placement of containers into storage rooms (this is the actually time when the study starts)
  • Confirm movement (cycling) of containers – optional
  • Confirm staging – optional
  • Confirm pull of containers from storage rooms
  • Registering stability samples into LIMS as required
  • Perform and record laboratory testing
  • Confirm scrapping of unused containers
  • Archiving stability protol and/or samples
  • Relocation of all containers from specific storage room/area – optional
  • Pull of “extra” containers – optional
  • Re-placement of containers used for non-destructive tests – optional
  • Report generation are generated throughout the process to show both preliminary and final informations

Features

  • Study/Protocol Definition
  • Batch/Lot Definition
  • Pull Times
  • Conditions & Condition Cycling
  • Tests
  • Container Placements, Movements, Scrapping
  • Project Shelf Life

Benefits

  • Simplifies study management from protocol design to graphical presentation of results
  • Increases efficiency by full management of storage room operations
  • Saves staff time by automatically registering pulled samples with tests and specifications
  • Minimizes implementation time by use of proven initial system
  • Provides built-in-bar-coded label generation
Stability Report

All reports are created using a seamless integration with Crystal Reports. Reports may be exported in many different formats including Excel™, Word™, HTML and more for inclusion into other documents.

In addition to printed reports, Matrix Gemini Stability also contains a link to Northwest Analytical’s Quality Analyst® for statistical analysis, which includes shelf life projections. Quality Analyst® is ICHQ1E compliant and produces shelf life projection using regression and ANCOVA. All the plots and graphs can be stored and integrated into other documents for final reports.

Stability Study Management
The complete solution for managing Pharmaceutical Stability testing

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