LIMS for Life Sciences and Pharmaceutical Organizations

All parts of the Pharmaceutical and Life Sciences business are under pressure to perform more effectively. Factors such as rising costs in bringing new drugs to market, limited patent time spans and increasing competition exert pressure on R&D organizations (including Clinical Research Organizations) to increase the rate and volume of new compound development and marketing. STARLIMS provides LIMS (Laboratory Information Management Systems) which are precisely designed to help life science and pharmaceutical organizations to meet these goals.

To help make informed decisions about the suitability of compounds throughout the development cycle, organizations must have access to the accurate data. Many research organizations also need to manage large-scale compound libraries used for medium or high-throughput screening, which present their own issues of sample and information management. At the same time, laboratories must also ensure the efficacy and safety of drugs; that all work is carried out in accordance with all relevant regulatory rules and regulations; and that all the data and information required for regulatory submissions is readily available.

Issues Confronting the Life Science Sector

Organizations responsible for performing the testing associated with clinical trials face their own laboratory data and information issues. This may include interfacing with clinical trial software and clinical analyzers, issues of confidentiality and security of information, the handling of kits used for testing (preparation, shipping, receipt and handling within the laboratory), and the reporting of results in the correct format to the sponsoring organization. Again this has to be done within the strict regulatory framework imposed on the pharmaceutical and life sciences business.

Helping Streamline Manufacturing Processes

Nowhere are the strict regulations and regulatory framework imposed on the pharmaceutical industry more evident than in the manufacturing sector. In drug manufacturing, the QA/QC laboratory must not only ensure that products meet the specified quality requirements, but they must also ensure that the product, manufacturing process and their own working practices adhere to the defined regulations. The laboratory must also ensure that any informatics systems in place are able to interface with other enterprise system such as Enterprise Resource Planning systems (ERP) or Manufacturing Resource Planning Systems (MRP), etc. What is more, the laboratory must work in such a way that it adds value to the manufacturing process and is not seen as a bottleneck within the manufacturing process.

STARLIMS Benefits for Life Science Labs

STARLIMS solutions for the pharmaceutical and life sciences provide the features and functionality required to help laboratory organizations involved in this area maximize their contribution to the business. In addition to the standard functionality and modules that support this industry, STARLIMS is also a fully web-based system that allows for simplified global deployment of the solution. LIMS is a vital component in helping both the R&D and manufacturing sectors of the pharmaceutical and life sciences industry meet their business and regulatory goals.

Pharmaceutical companies use GAMP guidelines for their validation of system such as LIMS. STARLIMS is concurrently designed with these guidelines. It is defined as a ‘Closed System” under 21 CFR Part 11, and classified as a Category 4 - Configurable Software Package.

STARLIMS addresses the needs of Pharmaceutical and Life Science organizations by providing functionalities such as:

• Ability to model Pharmaceutical and Life Sciences workflow requirements including a comprehensive module for defining and managing Stability Studies
• Advanced sample management, location and tracking functionality to support Medium and High Throughput screening including Plate Management
• Ability to store, manage and control all documents through the integrated Document Management system
• Full support for regulatory requirements including full Audit Trail and 21 CFR Part 11
• Full Lot and Batch Management facilities
• Support for complex and multi step testing processes such as Dissolution testing
• Full traceability of all data and information generated within the system
• Definition and management of multiple country or regional product specifications
• Support for required regulations and accreditation
• Ability to record and manage analyst certification Full equipment management and maintenance functionality Resource planning and scheduling functionality
• Flexible reporting functions that meet the complex requirements of a wide variety of internal and external customers
• Integration of analytical instruments and clinical analyzers to speed up data entry and reduce transcription errors
• Integration with other best of breed automation and enterprise systems including ERP/MRP systems, including a certified link to SAP, achieved through the use of a Web Services approach
  

In addition, the inherent flexibility of the system means that changes to business needs and working practices can be readily supported and implemented without losing existing functionality or data. STARLIMS is fully web-based and uses familiar user interfaces, which simplifies both user training and implementation in new sites or new parts of the organization. Global and multi-site deployment is also facilitated thanks to web-based technology.

About STARLIMS Corporation

With a 20-year track record of LIMS-only expertise, STARLIMS Corporation is a world-leading provider of commercial off-the-shelf (COTS) LIMS solutions. STARLIMS users can consolidate disparate lab and business processes into a single compliant platform—with full reporting, surveillance and networking capabilities. Entirely web-based and fully configurable, STARLIMS is a comprehensive solution to manage lab processes, ensure regulatory compliance and promote laboratory and enterprise collaboration.

A Powerful Off-the-Shelf Solution that is 100% Configurable

STARLIMS is a proven off-the-shelf solution with hundreds of deployments in every type of laboratory discipline (R&D, QC, process control, etc.). The same core software, used by all STARLIMS customers, is continuously upgraded to include hundreds of ready-made tools and wizards. In every industry (public health, pharmaceutical, chemical, petrochemical, forensic, environmental, food and beverage, water), STARLIMS ready-made tools meet the vast majority of lab requirements.

Configuring the rest is easy, using STARLIMS exceptionally flexible graphical configuration interface. Our unique workflow manager and intuitive drag&drop tools enable system administrators to rapidly establish and modify their laboratory’s unique workflow and business rules.

A Flexible Web-based System

STARLIMS is the only LIMS that brings all the resilience, reach and flexibility of the web into the lab. Built from the ground up as an entirely web-based application, STARLIMS offers efficient global deployment with no need for client-side installation, while accelerating learning curves and maintaining low cost of ownership. All this is combined with predictable response times and a rich, true-to-life GUI, to deliver a LIMS that lab users like to use.

Lab and Enterprise Collaboration

Leveraging XML and other open standard technologies, STARLIMS interoperates with a wide range of lab and enterprise systems—for streamlined information sharing within the lab and throughout the organization. The STARLIMS Data Capture Utility facilitates integration with analytical instruments and chromatographic workstations (including Waters® Millennium/Empower), and STARLIMS also interoperates with Microsoft® products, statistical packages, ERP systems, process automation systems, financial packages, healthcare protocols and more.

Regulatory Compliance

STARLIMS helps laboratories to comply with strict industry regulations—ranging from ISO/IEC 17025 to FDA 21 CFR Part 11. Flexible workflow tools provide complete traceability for full regulatory compliance, with no compromise in process versatility.

The core of the STARLIMS application is the automated electronic record-keeping function. An electronic signature is maintained in a relational database—encompassing test results, equipment settings, and all movements and activities.

International Services

STARLIMS solutions are supported by experienced specialists in the US, Canada, Europe, Africa, Asia Pacific and Latin America. Professional services may include system site surveys and analysis, prototyping, system administrator training, documentation, testing and validation documentation, on-site installation and integration with analytical instruments and enterprise systems. Local professional services teams are supported by our customer-focused R&D team, industry-specific Centers of Excellence, and an active User Group with representatives from leading global corporations and agencies.

A Long-Term Investment

STARLIMS is recognized worldwide as a future-proof system that enables labs to carry existing business rules and data into future versions. Data sets are maintained as business rules are modified to keep up with dynamic lab requirements; and business rules are kept when upgrading to newer STARLIMS versions. STARLIMS solutions are the most powerful information management tool labs have to promote compliance and collaboration today, tomorrow and in years to come.