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| OVERVIEW |
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| Xyntek has played a key role in assisting our clients in developing validation strategies/plans, conducting risk assessment, and providing a complete range of remediation solutions for their existing as well as new developed computer-based systems. Through years, Xyntek experience in Computer Systems Validation (CSV) spans a wide range of systems including Web-Based Ordering Systems, Inventory Management Systems, Enterprise Content Management Systems, MES, Instrumentation Systems, Laboratory and Analytical Systems, PLC, DCS, SCADA, and Machine Vision systems. With our expertise in Computer Systems Validation (CSV), in-depth knowledge of GxP regulations and 21 CFR Part 11 requirements, and experience in applying best practices for companies in the FDA regulated industries, you can be assured that Xyntek’s Validation and Compliance Group will help your company devise cost effective approaches to meet your company’s unique business needs as well as compliance needs. |
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| METHODOLOGY |
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| Xyntek’s Validation & Compliance Group follows an in-depth methodology that requires specific activities and deliverables that helps our clients achieve a high degree of assurance that each computer-based system will meet the pre-determined quality attributes and regulatory compliance. Our professionals will carry out the process of validating your company’s computerized systems by first understanding your company’s existing procedures and guidelines, adopting a risk-based approach to identify the key systems to implement appropriate controls, and using our expertise to develop all necessary documentation to ensure a validated system. We ensure that the system meets your business, technical, system, and regulatory requirements through all phases of the Software Development Life Cycle (SDLC), from initial Process Definition to Detailed Design & Development, Implementation, Validation, Training, and Long-term Support. |
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| CASE STUDY |
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| The following case studies are the success stories from our clients, the challenges that they faced and the solutions that Xyntek provided. These case studies demonstrate Xyntek�?????�????�???�??�?�¢??s experience in validation compliance and our potential to assist you in bringing your system to become fully operational and regulatory compliant. |
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Validation of Clinical Trials Management System
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| Xyntek was contracted to complete the validation effort for a global clinical trials management system, used in the top three pharmaceutical company. The system was a web-based GCP application designed to track the logistics of clinical trial management and was also integrated with external planning systems. Xyntek team developed a validation strategy to ensure that the system was deployed in accordance with quality software engineering principles, conducted validation activities including unit testing, system testing, User Acceptance Testing (UATs), and qualification testing, and generated a complete set of validation documentation including validation plan, change control report, UAT documents, etc. |
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Validation of SCADA System
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| Xyntek assisted a medicine and health care products manufacturer in validating their Liquids, Ointments, and Creams (LOC) Manufacturing SCADA system, and developing testing protocols. The test scripts included scripts for ensuring 21 CFR Part 11 compliance. As a result from the system assessment, Xyntek performed remediation actions including modifying application codes, updating system drawings, electrical wiring diagrams, and SOPs. Validation deliverables were developed including test plans, test summary reports, installation qualification (IQ), Operational Qualification (OQ), validation report, etc. |
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| CONTACT US |
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| For more information on Xyntek's validation and compliance experience, please contact us here. |
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