QMS/9000+TM
Features and Functions
4.15.3 Product Storage
Stability studies are done to prove that a product will
remain within specifications throughout its lifetime, including
the shelf life of the stored product. Accelerated studies are
done to quickly estimate product shelf life. Production stability
tests are periodically performed to detect deterioration and
ensure that the stored product continues to satisfy label claims.
QMS/9000+ provides for the scheduling, data
capture, database management, and reporting on both research and
production stability studies in a manner to comply with GMP/GLP
requirements.
- Open-ended number of shelf life and accelerated studies
- Study identification by product, condition, date, batch
testing schedule and other user-specified reference
information
- Automatic generation of "Pull" list-studies due
for testing
- Automated input device interfaces
- Data screening, laboratory calculations, confirmation of
acceptance, and documentation of results
- GMP/GLP regulations compliance
- Built-in checks to assure accurate data entry
- Laboratory labor hours accounting
- Early warning detection of trends
- Statistical analysis of kinetic data
- Sample label printing
- On-line maintenance of history for each stability study
- Graphical output via Arrhenius plotting using a kinetic
model to forecast product lifetime and provide early
warning of premature product breakdown at elevated
temperatures
JKA, Inc.
Phone: 732.991.2256 
FAX: 609.607.8527
E-mail: jka@qmsprograms.com
copyright 1998, JKA,Inc.
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