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| OVERVIEW |
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| A typical LIMS solution implements the following core functionality: Instrument analysis, Data Analysis, Data Reporting, Lab Management Functions and System Management Functions. In addition to the above mentioned core functionality, some LIMS solutions offer instrument control, sample scheduling, Quality control, invoicing and web-based reporting functionality. Studies have shown that LIMS implementations have been a pivotal reason Pharma R&D operations have achieved greater efficiency and ‘hits’. However, finding the optimum LIMS solution is integral in achieving this efficiency. By utilizing Xyntek’s expertise as a premier LIMS solution provider, our team of professionals will work in conjunction with your team to design and implement the optimal solution for your business. |
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| METHODOLOGY |
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Finding the best solution (LIMS or Content Management System) is integral in achieving a greater efficiency. The following factors are key in finding this solution. They also illustrate Xyntek�?????�????�???�??�?�¢??s expertise as a premier solutions provider.
- Define requirements
- Recommend the implementation plan
- LIMS Integration/Customization
- Computer System Compliance
- Continued support
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| CASE STUDY |
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Watson LIMS Implementation
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| Working closely with our client, a leading biotechnology company in PA, Xyntek has designed and implemented a LIMS solution & GxP Laboratory data management solution that interfaces with several laboratory instruments, including liquid handlers, analytical ultra-centrifuges, chromatography data systems, plate reader systems, flow cytometry systems, and spectroscopy systems. As part of designing, Xyntek has evaluated the GxP business-critical processes, technical, and regulatory requirements to ensure that the optimal solution was achieved. The level of customization was quantified to meet with study processes and analysis techniques used by the end-users. |
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LIMS On-Site Validation Support
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| With years of experience in LIMS implementation and unique expertise in regulatory compliance, Xyntek was selected by one of the major pharmaceutical companies to provide on-site validation support for their new LIMS application. Xyntek has generated GxP compliant test protocols, system-specific qualification protocols, as well as executed Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols to ensure that the system was compliant with the 21 CFR Part 11 regulations. |
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| CONTACT US |
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| For more information on Xyntek's Laboratory Information Systems (LIMS) experience, please please contact us here. |
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