SLIM

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The SLIM Solution from H&A Scientific.

A Laboratory Information Management System (LIMS) should make your job easier, not harder. Enter H&A Scientific’s SLIM (Stability Lab Information Manager). SLIM was developed and validated to provide total management of your drug products placed on stability. SLIM has the rich feature set required to meet the challenges today’s Lab Supervisors and Stability Managers face on a daily basis. SLIM’s fast, intuitive user interface and exceptional reliability provides simple, seamless operation, allowing it to manage your company’s drug stability program with optimal efficiency.

Operating under the principle that better software equals better science, H&A’s experienced chemists and scientists have spent over 20 years perfecting SLIM. Fine-tuned with extensive customer feedback and backed by world-class partner support, the SLIM Software Suite is the simple, yet powerful solution your company needs.

SLIM includes SLIMStat for statistical shelf life analysis and SLIM Report Generator (SRG), which simplifies presentation of final data for regulatory submission. SLIM’s off-the-shelf scalability allows it to remain affordable for businesses of all sizes, with installation, validation, training, and support provided by H&A Scientific. SLIMStat can also be purchased as a stand-alone application. All of our products are 21 CFR Part 11 complaint and fully validated per FDA and GAMP5 guidelines.

Key Features and Benefits

  • Completely new, streamlined User Interface for 2018!
  • Common actions are presented on the main browser/dashboard (SLIM Hierarchy Icons, To Do List, Calendars, LWR Counts, etc.)
  • Quickly add Core Components, such as Responsible Labs, Storage Chambers, Storage Conditions, Ingredients, Suppliers, Manufacturing Sites, etc in a centralized location
  • Protocol Editor for intuitive study/protocol creation and matrix design (simply choose time intervals and storage conditions, then drag-and-drop tests into the appropriate interval/condition cell)
  • Automatic time point scheduling, sample pull management, and resource scheduling
  • Complete stability database with extensive formulation capabilities
  • Secure data entry, verification, and approval with easy-to-use Lab Work Request (LWR) Form or Spreadsheet modes
  • Workload calendar functions allow for quick and simple rescheduling
  • E-mail notifications for Out-of-Spec (OOS) results, late lists, etc.
  • Stability chamber inventory management from setup to discard
  • Batch Analysis, Batch Summary and Turnaround Times Reports
  • Multi-level attachments allow documents and links to be attached to associated data
  • Product and study inventory labels
  • Alternate Test Specifications and Alert Limits, supports global marketing of drug products and tracking OOS results
  • Includes SLIMStat for statistical shelf life analysis and other valuable statistical calculations (see SLIMStat page for additional information)
  • Includes SLIM Report Generator (SRG) for seamless submission-ready reporting of your stability data (see SRG page for additional information)
  • Launch SLIMStat or SRG directly from SLIM with a click of a button

Study Protocol Creation & Modification

  • Easy to use Protocol Editor for simple and flexible protocol set-up
  • Reduce study creation time with easy-to-use time interval and storage condition selection process, drag-and-drop feature for adding required testing, and study copy-and-paste features
  • Capable of assigning multiple storage dates for different storage conditions for a single study
  • Automatic calculation of the number of units needed for each storage condition
  • Automatic calculation of schedule dates once Initiation Date is entered
  • Adhoc like-testing and study revision

Click the thumbnail to see a larger image of the Protocol Editor

Click the thumbnail to see a larger image of the Protocol Template Selector

Data Entry, Review, & Approval

  • Lab Work Request (LWR) data entry that passes through entry, verification, and approval status
  • Alternate Specs, Alert Limits, email notifications, electronic signatures, and change controls
  • 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.
  • Import/Export data to a third party software with our Systems Interface Module (SIM) Toolkit

Click the thumbnail to see a larger image of the Lab Work Request (LWR) Form

Calendar Functions & Reports

  • Generates weekly testing schedules, long-term forecasts
  • Easily create 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 that allow one-click grouping of upcoming work
  • Out-of-the-box systems reports include Stability Study Framework Report, Detailed Study Results Report, Inventory Report, and Out-of-Spec (OOS) Result Report, just to name a few

Click the thumbnail to see a larger image of the Workload Balance Calendar

Fully Validated Software

SLIM is a fully validated software system designed to be compliant with FDA guidelines for software development and validation. It includes functionality for electronic records, event logs/audit trails, change controls, and electronic signatures rules of 21 CFR Part 11 as they relate to “closed” systems.

SLIM also features a GAMP 5 Risk-based validation methodology that allows for a streamlined-yet-comprehensive, ready-to-execute IQ/OQ validation package – no need for complex testing of endless configurations.

Click the thumbnail to see a larger image of the Dashboard Interface

System Requirements

SLIM is a client/server application designed to utilize either a Microsoft© SQL Server database (2008R2, 2012, 2014, or 2016) or an Oracle database (10g or 11 g). Operating on Windows environments such as Microsoft® Windows 7, 8, and 10 and Microsoft® Windows Server 2008, 2012R2, and 2016, the SLIM software suite can be implemented on a standalone PC, local area network (LAN), or across the world using Terminal Server, Citrix, or the Cloud.

Speed. Stability. Accuracy. Productivity. These features are key in any modern stability laboratory information management system (LIMS). SLIM has them all — and more …

H&A Scientific’s SLIM. By stability professionals. For stability professionals.

What Our Clients Say About SLIM

  • We have utilized SLIM, SLIM Report Generator, and SLIMStat+ since 2006. Administration of the system requires very little time. The system is extremely stable, and does not require constant updates or fixes. System support provided by H & A Scientific staff is better than one could imagine.

  • “SLIM software helps me stay organized and compliant. It has an intuitive interface that makes it very user friendly. The tech support we receive from H&A Scientific is wonderful! I wish all software could be like SLIM!”

  • The software is a very useful tool, complying with the safety and traceability standards of the pharmaceutical industry. The software complies with the FDA and ICH Q1E recommendations, aiding us to fulfill the industry’s needs

  • As an IT Analyst, I have been supporting SLIM and SLIMStat in a laboratory environment for over ten years. This is by far one of the best constructed software systems we support. H&A has provided us with quality systems that usually only need attention when it’s time to upgrade.

  • H&A customer service is exceptional, reflecting their genuine interest for our implementation success. Their knowledge of ICH stability and software validation is evident in the design of the systems and their documents.

  • I evaluated several systems for a stability data base and statistical analysis. H&A promptly responded to my call, provided a thorough demonstration and a comprehensive, very reasonable quote.

  • We have utilized H & A Scientific staff for onsite and remote validation. This service is well worth the expense. Execution is fast and very thorough. The technicians are professional and work very hard to minimize disruption to the business.

STABILITY LABORATORY DATABASE MANAGER

Commercial off-the-shelf solution for complete management of your drug stability program.

INTUITIVE SHELF-LIFE PROTECTION SOFTWARE

Developed specifically to determine the shelf-life of drug products placed on stability.

VALIDATED & CUSTOMIZABLE REPORT GENERATION

Seamless generation of validated stability reports in a format ready for FDA submission.

DEDICATED TO CONTINUOUS IMPROVEMENT

Designed to maintain compliance with requirements of the FDA and GAMP.