SLIMStat

OVERVIEW: Determine the shelf life of pharmaceutical products using industry accepted calculations under 21 CFR Part 11 compliance.

SLIMStat is designed specifically to determine the shelf life of pharmaceutical products that have been placed on stability. Developed in accordance with the current GAMP and ICH guidelines, SLIMStat is a fully validated and tested software application that uses industry-recognized calculations yielding the same results as those in the FDA SAS program. SLIMStat also contains the functionality necessary to allow you to operate under 21 CFR Part 11 compliance.

SLIMStat is so easy to use it can be operated by a non-statistician using a desktop computer. Simply enter or paste the data in the SLIMStat data entry spreadsheet (time verses response) and SLIMStat automatically calculates the product's shelf life. SLIMStat can project expiry periods using either single or pooled stability studies. SLIMStat also automatically makes decisions as to the validity of pooling studies. SLIMStat also supports accelerated storage conditions (Arrhenius) calculations, trend analysis, and back calculation of purity. SLIMStat files can also be exported as graphic metafiles for insertion into word processing documents.

The latest version of SLIMStat, version 5.0.0, has been validated using the Windows 7 and Windows Server 2008 Operating Systems.

Standard and Accelerated Storage Conditions

SLIMStat determines shelf-life for standard storage conditions using the 95% confidence interval (upper, lower, or two-sided). ANACOVA calculations are used for determining the validity of pooling multiple studies. The studies are assigned a Model I,II, or III/IV designation according to ICH guidelines.


SLIMStat performs calculations for accelerated condition data using the Arrhenius equation, complete with an iterative, nonlinear regression technique to refine the estimates of the unknown Arrhenius parameters.


Trend Analysis

The user can enter a target time (in units of days, weeks, or months, depending on the time units of the displayed analysis) to calculate the predicted trend (result) at that time. Trend calculations are performed based on the displayed confidence interval, prediction interval, or standard deviation about the regression line.

OOT (Out of Trend) Result (Data Point) Detection

SLIMStat has the ability to statistically detect OOT results, and mark them as such. The user has the choice of using the Prediction Interval or the Standard Deviation about the Regression Line to determine if a result value (data point) is statistically OOT.

If using the Standard Deviation about Regression Line Test for OOT, one can use either the actual calculated Standard Deviation of the Residuals or one may input the known Standard Deviation of the Population.

OOT determination is very user friendly. Simply select a result (data point) to examine, and one can immediately determine if it is OOT or not.

Back Calculation of Purity

The user can enter a target time (in units of days, weeks, or months, depending on the time units of the displayed analysis) to calculate the initial purity of the drug required to obtain the desired projection or expiration date.

Method of Data Entry

SLIMStat is designed to accept stability data directly from SLIM. However, it is equally capable of functioning as an expiry dating tool when accepting stability data from the keyboard, clipboard, or spreadsheet program (in either row or column mode) such as Excel, which can save the data in a properly formatted text file that SLIMStat can import.

21 CFR Part 11 Compliance

SLIMStat includes functionality to meet the Electronic Records and Electronic Signatures rules of 21 CFR Part 11 as they relate to "Closed" systems. SLIMStat has multiple levels of security including a time-out procedure and prompted password expiry. Each SLIMStat user can have different security rights. The full audit trail includes references to the date and time of the change, the user that made the change, the type of change made, and a description of the change.

In Summary...

SLIMStat is included with each SLIM purchase, or it can be purchased and implemented as a stand-alone product.

Get SLIMStat and gain regulatory approval for your products with confidence.




Interested in Pharmaceutical Stability Training Courses in your region? Please contact us and we will explain the options we provide, both within the USA and Internationally. E-mail us at hainfo@hascientific.com or you may contact