A biding by FDA regulations plays a crucial role in determining the success of medical devices, pharmaceuticals, and biotechnology companies. It was no different for Baxter Healthcare, a medical products, and services company. Five of Baxter’s plants specializing in IV bags and solutions found their success through Abbott Informatics’ STARLIMS to integrate a wide range of multi-facility, system-wide, LIMS functionalities to enhance the company’s adherence to FDA regulatory rules. STARLIMS also helped the company in design and maintenance of a diverse spectrum of laboratory systems and applications, ensuring “mistake-proof” laboratory environments at the organization’s facilities.
STARLIMS, a comprehensive Laboratory Information Management System is designed to streamline highly complex processes of drug discovery and development. It handles the complete product lifecycle, from R&D, production, to quality assurance by the regulatory requirements. STARLIMS is able to meet a variety of challenges for pharma organizations such as allowing system configuration which meets the needs as well as the development of new enterprise versions, the standardization of user requirements, the performance of hardware and software upgrades and the ability to help address other organizational challenges such as personnel availability and communication barriers.
STARLIMS’ flexible, upgradeable, user-friendly, and robust system has enabled Baxter Healthcare to quickly adapt to new mandatory regulatory environments, while at the same time deploy systems modeled to the exact needs of the organization’s facilities and LIMS requirements. Ten years of STARLIMS integration has helped speed Baxter’s products and solutions to market while allowing for the flexibility to accommodate local differences in plant systems foregoing the need to design separate systems for each plant.
One can say that Abbott Informatics has created a niche market for itself by supporting the rapidly changing data management needs across an organization through their STARLIMS solution product suite. Abbott Informatics is an industry leader in providing functionality that can help customers monitor and control the safety and quality of their raw materials, processes, and finished products testing. It also helps document the results and manage the information in a secure and reliable way.
Robust LIMS Solution
With a commendable presence in the drug, medical device, contract lab, and biotechnology industries, STARLIMS is a scalable web-based product that allows organizations to connect from anywhere and anytime with full 21 CFR Part 11 compliant capable features to ensure data integrity, regulatory compliance, and inspection readiness.
Abbott Informatics is committed to building long-term relationships with every customer and focused on delivering customer satisfaction and quality results
STARLIMS offer a balance between flexibility, functionality, and usability for data management, whether a lab is stationed at one or multiple sites. The solution streamlines and automates the workflow and sample collection processes across the entire organization. STARLIMS includes powerful tools for comprehensive management of all laboratory processes including instrument management, inventory control & formulation management, flexible calculations, reporting & data analysis tools, analytical batch & plate management, standards & reagents management, comprehensive audit trail/electronic signatures, stability and microbiology management, and more.
STARLIMS has culminated into a comprehensive solution that improves quality and safety throughout the entire product lifecycle. It manages the collection, processing, storage, retrieval, and analysis of information generated in laboratories. Since 1987 STARLIMS has specialized in what it does best— delivering industry-leading laboratory information management solutions that enable organizations to respond to day-to-day challenges. STARLIMS’ team of experts have accumulated industry-specific know-how and best practices while configuring solutions to the needs of the customers, earning Abbott Informatics a reputation for high-quality service.
STARLIMS supports industry operational excellence efforts by helping with cost and error reduction through automation, integration, data consolidation, collaboration, process standardization, streamlining, and quality compliance. From R&D, clinical trials, to manufacturing and compliance, STARLIMS helps drive innovation throughout the entire product lifecycle. It configures workflows for a wide range of research projects and laboratory processes and interfaces with automated sample handling systems, analytical instruments, and system-to-system communications via web services, file transfer, and direct database communications. In addition, the users can oversee the workflows of their lab with intuitive dashboards.
STARLIMS also simplifies audit trails, electronic signatures, and chain of custody capabilities by ensuring that standard operating procedures and business rules are being followed.
It assists organizations to comply with FDA and other regulations and policies. Being a multi-tier solution with independent technology, data, and business layers, updates can be made to one tier without interfering with the others reducing risks, lowering the cost of ownership, and simplifying validation needs.
A Total Solution Partner
Abbott Informatics is known worldwide to provide organizations the tools and support they need to make sure they achieve quality results. In short, when an organization chooses to implement a STARLIMS, they choose to partner with Abbott Informatics, a dedicated team of global experts who have more than 30 years of domain expertise.
"From R&D, clinical trials, to manufacturing and compliance, STARLIMS helps drive innovation throughout the entire product lifecycle"
Abbott Informatics’ STARLIMS is a completely integrated solution incorporating LIMS, Electronic Laboratory Notebook (ELN), Scientific Data Management System (SDMS), Advanced Analytics and Mobility in a single application, eliminating the need for building and maintaining custom interfaces to third-party tools.
"STARLIMS’ team of experts have accumulated industry-specific know-how and best practices while configuring solutions to the needs of the customers, earning Abbott Informatics a reputation for high quality service"
STARLIMS offers a comprehensive formulation/recipe management, in addition to stability study management, environmental monitoring, Chromatographic Data Systems (CDS) integration, and more. It connects with Enterprise Resource Planning Systems (ERP), Product Information Management Systems (PIMS), Manufacturing Execution Systems (MES) and other enterprise systems via web services, file transfer, and direct database communications.
The company strongly believes their success is in the success of the clients. Abbott Informatics is committed to building long-term relationships with every customer and focused on delivering customer satisfaction and quality results. They are passionate about what they do and believe in their lab’s work. Backed by Abbott’s 125-year legacy of everlasting impact on human health, Abbott Informatics is passionate about enhancing the productivity of their customers. Whether an organization is focused on drug discovery, the creation of sustainable products or another goal, Abbott Informatics’ data management solutions helps fuel the organization’s mission and growth for years to come.