SLIM

SLIM est un logiciel LIMS de stabilité de niveau mondial entièrement validé. Le logiciel combine la facilité d’utilisation de l’interface utilisateur (logiciel de navigation sous forme d’objets), la création de rapports basés sur les documents standards de l’industrie avec la vitesse, la puissance et la capacité d’une réelle application serveur/client. Cette association de caractéristiques facilitera l’agrément réglementaire, minimisera les besoins en formation et les erreurs des opérateurs, et assurera que vos études de stabilité de drogues sont menées avec la plus grande efficacité.

SLIM combines the following unique combination of functional areas:
• Stability/Formulation Database
• Flexible Calendar Functions
• Inventory Management
• Resource Scheduling
• Shelf Life Prediction
• Trend Analysis
• 21 CFR Part 11 Compliant Features

Software

SLIM is a true client/server application written using Microsoft Visual C++. The client software runs on modern Windows operating systems such as Windows 2000, XP, and Vista. The server software is designed for Oracle version 9i or 10g and Microsoft SQL Server 2000 or 2005. 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.

SLIM was developed as a joint venture between Metrics, Inc. and H&A Scientific, Inc. Metrics is a contract analytical and pharmaceutical development laboratory with extensive experience in stability. H&A Scientific is a software development firm specializing in pharmaceutical industry support. Together, we designed this system from the ground up specifically for management of stability programs.