Stability Study Management

Configure, run and manage stability studies with ease

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Stability Study Management

Stability Study Management Workflow

Matrix Gemini Stability Study 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.

A set of standard reports are delivered with the system for reporting of the stability protocol and its associated results. Optionally, the system is also capable of producing projected shelf life trend analysis.

Stability Study Protocol

  • Create new stability protocols, or copy from an existing study template
  • Confirm placement of containers into storage rooms
  • Confirm movement (cycling) of containers
  • Confirm staging
  • Confirm pull of containers from storage rooms
  • Registering stability samples into LIMS as required
  • Perform and record laboratory testing
  • Confirm scrapping of unused containers
  • 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
Stability Study Protocol
Stability Study Reports

Stability Reports

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.

2020-05-18T17:22:04+07:00May 18th, 2020|

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