SLIMStat

SLIMStat, developed by H&A Scientific — the makers of SLIM — is an intuitive, fully validated shelf-life projection software designed specifically to determine the shelf life of drug products placed on stability. Built for pharmaceutical professionals, it empowers non-statisticians such as chemists, pharmacists, and formulators to generate rigorous statistical analyses with complete confidence, without requiring deep expertise in statistics.

SLIMStat is available as a standalone product or as part of the broader SLIM suite. It is fully validated in accordance with GxP guidelines, 21 CFR Part 11 compliant, and features a GAMP 5 risk-based validation methodology that supports a streamlined, ready-to-execute IQ/OQ validation package — deliverable on-site or remotely — eliminating the need for complex testing of endless configurations. Data can be imported directly from the SLIM database, entered via keyboard, pasted from the clipboard, or loaded from any suitably formatted text or Excel file.

Key Features and Benefits

• Determines shelf life using one-sided or two-sided 95% confidence intervals
• Calculates shelf life, trend analysis, out-of-trend (OOT) determinations, ICH Q1E batch pooling, back-purity, and kinetic analyses using the Arrhenius Equation
• Implements ICH Guidance for Industry Q1E Evaluation of Stability Data, including Pooled Mean Squared Error and Analysis of Covariance (ANACOVA) testing for poolability of batches
• ANACOVA calculations yield the same industry-recognised results as the program used by the FDA
• Graphical visualisation of data can be saved as Windows Metafiles or PDFs for easy insertion into other documents
• Company logos (bitmap) can be added to the header of SLIMStat printouts
• Generates reports in English, French, German, Japanese, Polish, Portuguese, and Spanish
• Configurable decimal separator and date formats, UNICODE compliance, and non-localised date-time audit logs for international acceptance
• User-selected treatment of Limit-of-Detection values
• Reduces regulatory risk through full GxP validation and 21 CFR Part 11 compliance

Long-Term and Standard Conditions Analysis

• Shelf life is determined using one-sided or two-sided 95% confidence intervals
• ANACOVA calculations are used to determine the validity of pooling multiple studies
• Studies are automatically assigned a Model I, II, or III/IV designation consistent with ICH Q1E guidelines
• Automatically makes decisions regarding the validity of pooling batches and studies — no guesswork required
• Tentative expiration dating periods can be estimated from accelerated stability data using the Arrhenius Equation
• Shelf life can be predicted at any valid temperature with a single click

Trend Analysis

• Predicts a future result (trend) based on a user-specified target date
• Trend calculations can be based on the displayed Confidence Interval, Prediction Interval, or Standard Deviation about the Regression Line

Out-of-Trend (OOT) Determinations

• Select any result to immediately determine whether it is statistically out-of-trend, with automatic notation
• OOT determinations can be made for a data point within a single batch or across many batches
• Choice of using the Prediction Interval or the Standard Deviation about the Regression Line, with the option to input a known population standard deviation

Back Calculation of Purity

• Users can enter a target time (in hours, days, weeks, or months) to calculate the initial purity of a drug required to achieve a desired projection or expiration date
• Supports both a Projection calculation type (based on Y=mx+b) and an Expiration Date calculation type (based on the displayed Confidence Interval)

21 CFR Part 11 Compliance and Security

• Meets Electronic Records and Electronic Signatures rules of 21 CFR Part 11 for closed systems
• Features multiple levels of security including prompted password expiry and a time-out procedure
• Each user can be assigned different security rights
• Full audit trail is maintained throughout

SLIMStat integrates seamlessly within the H&A Scientific SLIM suite alongside the SLIM stability study management platform and the SLIM Report Generator for FDA-submission-ready reporting. It is well recognised across the pharmaceutical industry as a validated, easy-to-use tool for regulatory filings and stability programme management.