SQL*LIMS® Software integrates the following core functions into a commercial-off-the-shelf (COTS) configuration tailored to different industries and applications:

1. Lot and batch management
2. Quality assurance
3. Stability studies
4. Core analytical laboratory management
5. Environmental monitoring
6. Connectivity to laboratory instrumentation

1. Lot and batch management
With SQL*LIMS Software, you can configure how you create and manage lots and batches according to your particular workflow. SQL*LIMS is organized like your manufacturing process, using the lot/manufacturing step/sample/test/result hierarchy. From one easy-to-use screen, the entire lot disposition can be viewed. This screen shows the lot identification and its current status, and any associated information about the batch: material codes, product names, and lot history.

The lot management capability allows lots to be tracked, along with the genealogy, e.g., what ingredients were used to create the lot, and the associated testing on the ingredients. The lot disposition, including any problems associated with the lot, is easily viewed.

Once a lot plan has been put in place, samples from the shop floor can be quickly and easily received into the lab either manually or with the swipe of a barcode. Once received information such as priority or associated data can be updated and the sample released for testing.

2. Quality assurance
Pharmaceutical manufacturing provides an example of how the quality assurance functionality works in many industries that use SQL*LIMS: Raw materials in uniquely numbered lots enter in manufacturing process and are combined at different stages to create uniquely numbered work-in-progress lots. Ultimately, these materials are used to form the final product. Samples of each material need to be tested to assure product quality. If the materials pass testing, production continues. If materials fail, they need to be quarantined and cross-checked against other lots for known problems.

SQL*QA™ Software streamlines this testing process. SQL*LIMS allows customers to efficiently manage the definition, review, and disposition of product or material lots. It tracks every stage of the manufacturing process that requires laboratory testing, from raw materials to finished products.

In SQL*QA, raw material samples can be easily logged according to a pre-defined sampling plan. Multiple sampling plans can be created and stored. The specifications for raw materials and the vendor information may be stored and used to sample the incoming materials. Lot plans may be initiated to begin the process.

With its enhanced functionality, you can easily create lots and quickly define when you analyze material samples. When you or the system create samples, the analysts then use the system to perform analysis, enter results and approve results, providing you with the information you need to accurately release product lots.

SQL*QA also meets the requirements of the FDA electronic records rule in 21 CRF 11. SQL*QA™and SQL*LIMS both provide a complete audit trail and electronic signature capability.

3. Stability studies
Stability testing assesses the shelf life of products under different combinations of product package type, temperature, humidity, and any number of other variables. SQL*Stability™ software manages this testing and enables customers to define the test parameters for stability studies, including sampling time points, package types, and test methods. The software is set up to facilitate regulatory compliance and provide a complete audit trail and electronic signature for data.

SQL*Stability software also provides a comprehensive inventory solution for tracking, storage, and release of items based upon existing SQL*Stability study protocols enabling users to:

• Receive Stability items into inventory
• Track items within inventory
• Manage inventory movement and storage
• Remove items based upon stability protocol pull schedules and perform additional unscheduled pulls
• Restock items, reconcile, and mark left over items as destroyed
• View history of inventory items

4. Core analytical laboratory management

• Easy-to-Use for Day-to-Day Analysis
  We have designed SQL*LIMS Software to provide an easy-to-use interface for analysts using the application on a daily basis. We provide multiple forms to allow you to create samples, and enter, approve, and review results. From the hundreds of forms that we provide, you can determine which fit your environment and then implement only those particular forms.
   
• Dynamic Screen Translation
  For every field on every form SQL*LIMS allows you to define the language in which text appears. These foreign language translations allow you to bring the form into the context of your laboratory. Currently SQL*LIMS has been translated into Spanish, French, German, Italian, and Kanji. Different users in your operation may have different translations, which you can dynamically change at any time.
   
• Complete and Automatic Reporting
  We understand that retrieving data from your system is critical to any successful implementation. Providing an open system that allows you to select from a huge array of Oracle® platform based reporting, data mining and visualization tools is a primary benefit of SQL*LIMS Software. SQL*LIMS comes bundled with Oracle Reports. This easy-to-use tool allows you to take full advantage of the relational database design and build simple or complex reports. With a push of a button, these reports can be linked to the SQL*LIMS software forms to automatically generate a report based on the user’s context. SQL*LIMS comes with a large number of example reports that will help you get started.
   

5. Environmental monitoring
SQL*Schedule manages the interval testing and environmental monitoring of your facilities. For example, you might need to monitor the pH of liquid in a cooling system, the bacterial contamination in a room, or the calibration of an instrument or device. SQL*Schedule provides a solution that manages routine processes of interval testing from sample collection worksheets to management of test results. With this enhanced functionality you can define sampling files, sampling points, and sampling schedule.

6. Connectivity with laboratory instruments
Developed in partnership with Labtronics Inc., IDM-LimsLink™ links your instruments and Applied Biosystems SQL*LIMS into one seamless, automated solution. With this software, which is seamlessly integrated into SQL*LIMS Software, you can manage the flow of data to and from many different sources and connect any instrument to your SQL*LIMS system.

• Increase sample throughput by automatically collecting, calculating, and reporting your laboratory data
• Eliminate transcription errors introduced by tedious manual data entry
• Help you meet ISO 9000 and regulatory guidelines easily through improved data security
• Reduce implementation and training time by using a standard platform for all instruments in your laboratory
• Increase sample throughput by automatically collecting, calculating, and reporting your laboratory data

IDM LimsLink™ Software also lets you combine data from multiple instruments and use many common analytical techniques, such as standard curves, QC analysis, and limit checks. We developed the software to help you to meet the needs and regulatory guidelines of every major industry, including the petrochemical, pharmaceutical, industrial, environmental, food/beverage, and biotechnology industries.