SLIM

OVERVIEW: The established "World Standard" Solution for Management of a Pharmaceutical Stability Program.

SLIM (Stability Lab Information Manager) is the state-of-the-art LIMS for complete management of your drug stability program. From the design of stability study protocols to statistical analyses with SLIMStat and presentation of final data for regulatory, e.g., FDA, submission, your stability program can not be better managed.

With well over 80 SLIM implementations in the pharmaceutical industry throughout the world since 1997, SLIM continues to set the standard for stability management. SLIM was designed by pharmaceutical stability scientists from the beginning to be a total solution for management of a stability program, and not just an afterthought “add-on.” If your requirements specify the absolute best Stability Management System in the world with time-tested proven reliability and excellent support, then SLIM is your answer. It’s that simple!

SLIM combines the following unique combination of functional areas:
• Stability (including extensive Formulation capabilities) Database
• Data entry via WYSIWYG Forms or Spreadsheet mode, as well as automated methods
• Flexible calendar functionality, including e-mail notification
• Complete Inventory Management
• Resource Scheduling
• Shelf Life Prediction according to Q1E ICH Guidelines
• OOT Detection / Trend Analysis using CI, PI, or StdDev of Residuals
• Fully Integrated 21 CFR Part 11 Compliant Features

Software

SLIM is a true client/server application. The client software (written using Microsoft Visual C++) runs on modern Windows operating systems such as Windows 2000 through Windows 7. The server software is designed for Oracle version 9i through 11g or Microsoft SQL Server 2000 through 2008. SLIM can easily manage thousands of stability studies with exceptional speed operating on a stand-alone PC, a local area network (LAN), or wide area networks (WAN) such as a terminal server or Citrix.

SLIM is a fully validated software system. It combines an extremely intuitive browser user interface that allows the user to access multiple levels of detail within the database with industry standard document technology-based reporting. It features the speed, power, and capacity of a true client/server application. This combination of features will assist in regulatory approval, minimize training requirements and operator errors, and ensure that your drug stability studies are managed with the utmost efficiency.


Calendar Functions

• Generates weekly testing schedules, long-term forecasts and late lists
• Easily create product-specific or test-specific schedules
• Supports multi-laboratory scheduling of tests


Data Entry, Review, and Reports

Lab Work Request (LWR) data entry forms are interactive forms that allow each user to enter results on screen into forms that look exactly like the printed form. The data passes through entry, verification, and approval status.


The extensive report architecture features, such as filtering and sorting of tabular reports, interactive forms, and automatic report generation provide powerful tools for customization of reports.

Selected tabular data may be saved to the clipboard for exporting into other applications, or data may be exported directly from SLIM into Microsoft Word or Excel.


Multiple report templates for stability protocol framework, annual product review, audit trail, OOS investigations, etc.


21 CFR Part 11 Compliance

SLIM includes functionality to meet the Electronic Records and Electronic Signatures rules of 21 CFR Part 11 as they relate to "Closed" systems. SLIM has multiple levels of security including a time-out procedure and prompted password expiry. Each SLIM 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.


About SLIM...

SLIM is positioned as a world-class stability LIMS with cost effectiveness and scalability that allow it to remain affordable. The SLIM Report Generator and SLIMStat are included with each SLIM implementation. Each SLIM system also includes on-site installation, training, and support by H&A Scientific, Inc.



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