SLIM

SLIM (Stability Laboratory Information Manager) is a comprehensive Laboratory Information Management System (LIMS) developed by H&A Scientific specifically for pharmaceutical stability study management. Built on over 30 years of refinement by experienced chemists and scientists, SLIM is designed to make the work of Lab Supervisors and Stability Managers easier through a fast, intuitive user interface and exceptional reliability. The platform enables complete management of a company's drug stability program with optimal efficiency, operating under the principle that better software equals better science.

SLIM is a fully validated, 21 CFR Part 11 compliant software suite developed in accordance with FDA GxP and GAMP 5 guidelines. It is offered as a commercial off-the-shelf solution with off-the-shelf scalability, making it affordable for businesses of all sizes. The suite includes two companion applications — SLIMStat for statistical shelf life analysis and SLIM Report Generator (SRG) for submission-ready reporting — both of which can be launched directly from within SLIM. SLIMStat is also available as a stand-alone application.

Key Features and Benefits

• Completely new, streamlined user interface with common actions presented on the main dashboard, including SLIM Hierarchy Icons, To Do List, Calendars, and Lab Work Request (LWR) Counts
• Centralized location for quickly adding core components such as Responsible Labs, Storage Chambers, Storage Conditions, Ingredients, Suppliers, and Manufacturing Sites
• Protocol Editor for intuitive study and protocol creation and matrix design, with drag-and-drop functionality for adding tests to interval and condition cells
• Automatic time point scheduling, sample pull management, and resource scheduling
• Complete stability database with extensive formulation capabilities
• Secure data entry, verification, and approval via easy-to-use Lab Work Request (LWR) Form or Spreadsheet modes
• Workload calendar functions for quick and simple rescheduling
• Email notifications for Out-of-Spec (OOS) results and late lists
• Stability chamber inventory management from setup to discard
• Batch Analysis, Batch Summary, and Turnaround Times Reports
• Multi-level attachments allowing documents and links to be associated with relevant data
• Product and study inventory labels
• Alternate Test Specifications and Alert Limits to support global marketing of drug products and tracking of OOS results
• Integrated SLIMStat for statistical shelf life analysis and SRG for seamless submission-ready reporting

Study Protocol Creation and Modification

• Easy-to-use Protocol Editor for simple and flexible protocol set-up
• Reduces study creation time through intuitive time interval and storage condition selection, drag-and-drop test assignment, and study copy-and-paste features
• Capable of assigning multiple storage dates for different storage conditions within a single study
• Automatic calculation of the number of units needed for each storage condition
• Automatic calculation of schedule dates once an Initiation Date is entered
• Supports ad hoc like-testing and study revision

Data Entry, Review, and Approval

• Lab Work Request (LWR) data entry workflow passing through entry, verification, and approval statuses
• Supports Alternate Specs, Alert Limits, email notifications, electronic signatures, and change controls
• Selected tabular data can be saved to the clipboard for export into other applications, or exported directly from SLIM into Microsoft Word or Excel
• Import and export data to third-party software via the Systems Interface Module (SIM) Toolkit

Calendar Functions and Reporting

• Generates weekly testing schedules and long-term forecasts
• Supports creation of product-specific or test-specific schedules
• Supports multi-laboratory scheduling of tests
• Workload calendar allows users to view and adjust the upcoming work schedule
• Pull Calendars enable one-click grouping of upcoming work
• Out-of-the-box system reports include Stability Study Framework Report, Detailed Study Results Report, Inventory Report, and Out-of-Spec (OOS) Result Report, among others

Validation and Compliance

• Fully validated software system designed to comply with FDA GxP guidelines for software development and validation
• Includes functionality for electronic records, event logs and audit trails, change controls, and electronic signatures in accordance with 21 CFR Part 11 for closed systems
• Features a GAMP 5 risk-based validation methodology with a streamlined, ready-to-execute IQ/OQ validation package, eliminating the need for complex testing of endless configurations

System Requirements and Deployment

• Client/server application fully validated for use with Microsoft SQL Server (2014, 2016, 2017, 2019, or 2022) or Oracle database (10g, 11g, or 19c)
• Fully validated on Windows 10, Windows 11, and Windows Server 2016, 2019, and 2022
• Can be deployed on a standalone PC, local area network (LAN), or globally via Terminal Server, Citrix, or the Cloud

H&A Scientific provides installation, on-site or remote validation, training, and ongoing support for the SLIM Software Suite. The platform is designed and maintained by stability professionals for stability professionals, with continuous improvement aligned to FDA and GAMP compliance requirements.