Elevate Compliance and Operational Excellence.
At SmartSPOC, we offer comprehensive computerized system validation services designed to enhance your compliance and operational efficiency. Our team of experts collaborates closely with clients to validate a broad spectrum of computerized systems, from PLC-based systems, HMIs, and SCADAs to advanced laboratory instruments like HPLC, UV, KF, and ICPMS. We also specialize in validating enterprise applications such as QMS, LMS, LIMS, Argus, and SAP, ensuring they meet the highest industry standards and regulatory requirements.
Rigorous Validation Processes.
Our validation approach is grounded in the latest industry standards, including GAMP 5, ASTM E2500, and ICH guidelines. We conduct thorough validation processes that guarantee the reliability and compliance of your systems.
IT Infrastructure Qualification.
A robust IT infrastructure is critical for your operations. We ensure that your IT infrastructure meets all necessary standards without compromising on technology or compliance, providing a solid foundation for your business.
Our Offerings
Regulatory Compliance Services.
With extensive experience in the regulated life sciences industry, SmartSPOC ensures that your operations align with all relevant regulatory standards.
Comprehensive Validation Services.
Our team delivers end-to-end validation and qualification services, ensuring your systems operate effectively and comply with stringent industry standards.
IT Infrastructure Qualification Services.
As the life sciences industry increasingly adopts new technologies, our services ensure that your IT infrastructure is both qualified and compliant with industry requirements.
Spreadsheet Validation Services.
We apply GAMP 5 and other industry best practices to our spreadsheet validation processes, ensuring accuracy and reliability in your data management.
Specialized Computerized System Validation Services.
In a rapidly evolving landscape, reliance on computer systems is paramount. SmartSPOC offers specialized validation services to ensure that your computerized systems are compliant, reliable, and capable of supporting your business growth.
Validated and Certified Custom Applications.
At SmartSPOC, we provide validation and certification services for custom applications within the IT industry, ensuring compliance with industry standards while optimizing performance. Our expertise spans a range of innovative tools, including:
- Maiora Data Suite – Zarus
- Phyxis: A file management system designed to streamline document handling and ensure secure data storage.
- Do it Right: A data transformation module that guarantees accuracy in processing and conversion workflows.
- Olanota: A powerful visualization tool that transforms data into actionable insights for informed decision-making.
- Idmx 2.0 for Neuvays (MckinSol): We offer advanced validation for Idmx 2.0, ensuring the platform meets stringent compliance standards and operates efficiently within regulated environments.