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| OVERVIEW |
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Xyntek has played a key role in helping our clients succeed in the competitive Life Sciences Industry from Drug Discovery Research & Development to Pre-clinical & Clinical Operations, to Automated Manufacturing and Packaging, to Supply Chain, to Regulatory and GXP Compliance. Our real-time turn-key design & implementation professional services of Information Management & Technology, Laboratory Automation, Process Control Automation, and Regulatory Compliance have been utilized by top Life Sciences companies looking for an edge in this dynamic environment of quickly evolving process & technology and rapid globalization.
Xyntek's unique blend of real-time system solutions composed of hardware & software expertise, along with our keen Process knowledge and understanding of the Life Sciences Industry and cGXP requirements makes us a valuable asset to companies looking to improve supply chain performance while complying with existing regulations. |
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| METHODOLOGY |
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| All of Xyntek's business solutions are developed in accordance with our stringent Project Management & Software Development Life Cycle. We ensure that our solutions meet your business and process requirements from initial Process Definition to Detailed Design & Development, Implementation, Compliance, Training, and Long-term Support. |
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| RELATED SERVICES & PRODUCTS |
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In the Life Sciences Industry, Xyntek provides state-of-the-art real-time solutions composed of services and products to support all phases throughout the Drug Development Life Cycle (DDLC).
Drug Discovery
- Process Analysis
- Modeling & Simulation
- Laboratory Automation & Application Development
- LIMS Solutions
- Electronic Laboratory Notebook (ELN) Solutions
- Web-based Materials Management Solutions
Drug Development
- Laboratory Automation & Application Development
- Electronic Laboratory Notebook (ELN) Solutions
- Instrument Interfacing
- LIMS Solutions
- Informatics
- Machine Vision Solutions
- GLP Regulatory Compliance
Clinical Trials and Clinical Manufacturing
- MES Solutions
- Inventory Management Solutions
- RFID Solutions
- Line Automation Solutions
- eClinical Solutions
- eSubmissions
- GCP Regulatory Compliance
- Clinical Manufacturing Solutions
Bulk Manufacturing
- Process Development Engineering Services
- Real-Time Batch & Continuous Process Control
- Line Automation Solutions
- MES Solutions
- Inventory Management Solutions
- Electronic Batch Record Solutions
- DCS System Implementation
- SCADA Solutions
- GMP Regulatory Compliance
Packaging Line
- Inventory Management Solutions
- Manufacturing Line Automation
- MES Solutions
- SCADA Solutions
- Machine Vision Solutions
- GMP Regulatory Compliance
Regulatory Compliance
- Quality & Compliance Coaching
- 21 CFR Part 11
- Computer System Validation
- Instrument & Equipment Qualification
- Network Qualification
- Facilities Commissioning
- Technical Writing Services
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| CASE STUDY |
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| Please take a look at the following case studies to see how Xyntek has implemented "turn-key" solutions for the leading companies in the Life Sciences Industry. |
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Batch Control Solution - Fluid Handling System for Tissue Purification Process
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| Xyntek, Inc. provided a turn-key automated fluid handling system that was developed for a tissue purification process, for a non-profit organization that is dedicated to providing tissue transplants. The system was designed in accordance with the ISA S88 batch processing standards and principles. Rockwell Automation products were utilized during design and development of HMI/SCADA, recipe management, defining batch operations, as well as communication and network management. The system architected the SQL Server database and was validated to ensure compliance with 21 CFR Part 11. The new automated system resulted in over 50% increase in performance and throughput, and dramatically reduced human error involved in the operation, thereby increased efficiency and at the same time improved quality of operations. |
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LIMS Solution - 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 & 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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21 CFR Part 11 Gap Analysis & Remediation using CyberLAB - Data/Content Management Solution
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| For one of our leading clients, conducted 658 system assessments for GMP and GLP regulated analytical research systems and instruments in over 115 labs found in the Drug Evaluation, Chemical and Pharmaceutical Development, and Preclinical Development divisions, for the clients 21 CFR Part 11 program. Systems included HPLCs, GCs, GC/MS, LC/MS, Arrays, NMRs, Plate Readers, Scintillation Counters, UV and FL Spectroscopy, UV/Vis Dissolution, TOC, LIMS, and other stand-alone instruments & computer controlled equipment. Activities included system assessments and Gap Analysis, vendor audits, development of system specific Corrective Action Plans, procedural and/or technical remediation solutions, and re-validation. Implemented CyberLAB, a knowledge engineering system to collect, organize, warehouse and archive all structured and unstructured electronic records to create a secure, 21 CFR Part 11 compliant, centralized electronic libraries. |
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Drug Discovery - Compound Fulfillment System Development & Implementation
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| Developed a compound filfillment system for one of the top five pharmaceutical companies of the world. The project involved development of software modules that interfaced and communicated with automated tube stores (Thurnall), vertical storage carousels (Titan), laser pointing systems (ITX-LPS), liquid handling automation (Tecan, Packard, TAP, TomTec), labeling/weighing automation (Bohdan), weigh scales (Sartorius), barcode printers (Zebra), and barcode scanners (Symbol, 2D matrix). Designed and developed a compound storage retrieval system, which supports a compound inventory of over 4 million dry/soluble compounds. Validated the entire compound fulfillment system for 21 Part CFR 11 compliance, and provided review and documentation. Reengineered and redesigned the compound fulfillment system by integrating islands of automation. As a result, compound order fulfillment was increased over 100%. |
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Laboratory Automation System Implementation
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| Provided Laboratory Automation of CACO2 Cells to one of our leading clients, which resulted in use of 59 axis of robotics movement, CRS Robotics, TECAN Liquid Handlers, HotPak Incubators, Refrigerators, Accusort Bar Code Scanners, Zymark Label Printers, Sealers, Heater/Chiller Units, PLC’s, & instrumentation. Xyntek was involved in process analysis, design & documentation, user requirements, functional design specifications, software & hardware architectural design, software programming, hardware configuration, testing, UAT, validation and documentation. The software development resulted in full integration of all the above equipment. The whole operation from retrieving the trays, to running the cell feeding and permeability assays, to storage was fully automatic. The software could be accessed remotely, and using the camera view function, the lab could be fully monitored not only through the software functions but also through the cameras. The final solution was fully validated and was 21 CFR-11 compliant. |
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| CONTACT US |
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| For more information on Xyntek's industry related experience, please check out our industry related links or contact us here. |
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