The STARLIMS Pharma & Biotech Solution is established in the biotechnology, contract lab,  contract manufacturing, drug, and medical device industries. Scalable and web-based, this product lets labs connect anytime and anywhere. In addition, the solution is compliant with 21 CFR Part 11, ensuring data integrity, inspection readiness, and regulatory compliance.

• Consolidation of sample data and documentation
• Production of Certificates of Analysis (CoA) for samples that meet specifications
• Generation of stability summary reports
• Analysis of testing trends while handling EP, ICH, JP, and USP standards
• STARLIMS assists labs’ compliance with ANVISA, cGMP, FDA, and ISO 17025, as well as other regulatory best practices and requirements
• Production of real-time analysis of tested samples

The STARLIMS Integrated Solution is a single robust application and integrated solution providing Advanced Analytics, Electronic Laboratory Notebook (ELN), Laboratory Information Management System (LIMS), Laboratory Execution System (LES), and Scientific Data Management System (SDMS) that is one of a kind in the industry.

A market leader, STARLIMS provides functionalities that monitor and control the quality and safety of an organization’s testing of raw materials, manufacturing processes, and finished products. This proven platform documents results and manages data reliably and securely.

Pharmaceutical & Biotechnology Lab Management

STARLIMS software features the following powerful tools for the management of every laboratory process:

• Analytical batch and plate management
• Chromatographic data systems (CDS) integration
• Comprehensive audit trail/electronic signatures
• The flexibility of calculations, as well as data analysis and reporting tools
• Instrument and formula management, along with inventory control
• Microbiology and stability management
• Reagents and standards management
• Request Management Portal
• Resource and scheduling planning

Operational Excellence

Attaining operational excellence by innovating, the STARLIMS Pharmaceutical & Biotech Solution helps organizations achieve greater efficiency and quality.

The solution decreases costs and errors via automation, data consolidation, integration,  process standardization and streamlining, and quality compliance.

Part 2 will discuss the critical components of STARLIMS.

Alpha LIMS Implementation

Alpha has implemented over 50 LIMS systems ranging in size from small, “off-the-“helf” software” systems to very large, highly customized, multi-functional systems, including STARLIMS, for governmental agencies and private enterprises. For affordable client-focused network consulting services and solutions, please call Alpha today at (410) 295-9500.