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Industries

It can be helpful to categories laboratories by the industries they serve, each of which has its own particular requirements for LIMS functionality. Blaze Systems has the LIMS products, features, expertise, experience and demonstrated track record required to provide superior LIMS installations for any of these industries:

Laboratories for the Biotechnology industries may be in support of R&D and/or manufacturing. They are characterized by a high stake in comprehensive data capture and subsequent data management. Activities range from designing and managing experiments to developing and executing reproducible manufacturing processes. There is high value in data sharing and efficient access to archival information. Data quantities can be large and must be gathered with a high degree of automation and with trace ability through sometimes complex processes. There are a large number of smaller or startup Biotechnology laboratories where low cost and broad functionality are critical.

Clinical laboratories require error free traceability of data to patients or subjects while retaining confidentiality. This implies absolute sample identification procedures. Data integrity features are essential to insuring data that is above reproach. Easy and usable access to patient/subject history is required to evaluate results and determine subsequent testing strategies. Planning tools are required to enforce/enable proper execution of protocols such as in clinical trials. Predictable turnaround, airtight QC, and prompt and accurate notification are required.

Laboratories for the discrete industries may be in support of R&D and/or manufacturing. They are characterized by the need for flexible data organization/identification and effective mapping to the unit of manufacture/testing. Statistical methods of quality evaluation predominate. Early warning of off-aim performance is highly value able. High quantities of data usually mandate automated data capture and statistical control. Comprehensive specification management is necessary. Specialized imaging and image capture as well as the ability to track and bring closure to unusual events is necessary. Integration with MPR/ERP systems is often necessary.

Laboratories for the Electronics industries may be in support of R&D and/or manufacturing. They are characterized by the need for flexible data organization/identification and effective mapping to the unit of manufacture/testing. Statistical methods of quality evaluation predominate. Early warning of off-aim performance is highly valuable. High quantities of data usually mandate automated data capture and statistical control. Comprehensive specification and recipe/sop management is necessary. Specialized imaging and image capture as well as the ability to track and bring closure to unusual events is necessary. Integration with MPR/ERP systems is often necessary.

Environmental laboratories may be a mix of highly structured or ad-hoc sampling, driven by external dynamics that range from managed (environment monitoring) to unpredictable (emergency response). Emphasis is on secure chain-of-custody, data integrity, confidentiality, impartiality, demonstrably correct results, demonstrating and maintaining proficiency and standards compliance (e.g. NELAC), responsiveness and standardized EDD reporting mechanisms (e.g. SEDD).

Laboratories serving the Food and Beverage industries are dominated by their status as an FDA regulatory domain. Emphasis is on regulatory compliance (GMP, GLP, 21CFR Part 11, etc.), validation status, full traceability, precise sample identification and tracking, documented and insured corrective actions, established and controlled methodology, reproducibility, accountability and tamper proof information.

Laboratories serving the Pharmaceutical Industries are dominated by their status as an FDA regulatory domain. Emphasis is on regulatory compliance (GMP, GLP, 21CFR Part 11, etc.), validation status, full traceability, precise sample identification and tracking, documented and insured corrective actions, established and controlled methodology (SOP document management), reproducibility, accountability and tamper proof information. Traceability must be comprehensive of all elements of the laboratory process including prep (scales, pipettes, reagents, technicians, etc.) analysis (primary instrument, technicians, standards, controls, etc.) and the entire laboratory quality assurance process. For smaller enterprises the LIMS may also implement substantial portions of EPR functionality such as recipe/SOP management, raw material, in-process and finished product inventory, and process managements (batch, fill, package, ship).

Laboratories serving the Process Industries are characterized by sampling and workflow that are highly structured and optimized according to the requirements of the manufacturing supply chain, process, product, customer base, etc. Emphasis is on efficient, reproducible, automated and rapid logging, processing, and delivery of results, specification management, advanced integration with other enterprise systems (ERP, Shop Floor Control, Process Control, etc.) and the customer support function, and support for conformance to manufacturing standards (ISO, GMP).

In addition to the above, every laboratory exists in a unique environment with a potential for impacting the success of the enterprise in achieving its mission in unique ways, and with a particular set of effectiveness measures. Blaze Systems products and services are structured to optimize the impact of a LIMS installation within its unique environment.