Stability Study Management
The complete solution for managing Pharmaceutical Stability testing
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
Features
- Study/Protocol Definition
- Batch/Lot Definition
- Pull Times
- Conditions & Condition Cycling
- Tests definition
- 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
Reporting
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.
