Stability Study Management2022-11-30T16:39:15+07:00

Stability Study Management

The complete solution for managing Pharmaceutical Stability testing

Stability Study Management

Stability Study Management

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.

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 protocol 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
Stability Study Protocol


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


  • 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


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 Reporting

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