SLIMStat is extremely easy-to-use software developed and validated specifically to determine the shelf life of drug products that have been placed on stability. This interactive and intuitive tool empowers non-statisticians the ability to generate statistical analyses with complete confidence. Fully validated and 21 CFR Part 11 compliant, SLIMStat accepts data directly from the SLIM database, keyboard, clipboard, or any suitably-formatted text/Excel file. The product’s shelf life for single or pooled studies are then automatically calculated. It’s that easy!
SLIMStat also features a GAMP 5 risk-based validation methodology that allows for a stream-lined-yet-comprehensive, ready-to-execute IQ/OQ validation package - no need for complex testing of endless configurations.
Click the thumbnail to see a larger image of the Pooled Batches screen
Click the thumbnail to see a larger image of the Standard Storage Conditions Model Analysis
Click the thumbnail to see a larger image of the Accelerated Storage Conditions Analysis
Click the thumbnail to see a larger image of the OOT Determination screen
SLIMStat’s functionality meets the Electronic Records and Electronic Signatures rules of 21 CFR Part 11 as they relate to “closed" systems. It features multiple levels of security, including prompted password expiry, a time-out procedure, the ability for each SLIMStat user to have different security rights, and a full audit trail.
Click here to Request Information or schedule a WebEx Demonstration