Computer Systems Validation
ERP Systems (SAP, Oracle, Microsoft Dynamics 365, Prophet 21, IFS)
We specialize in validating ERP systems such as SAP, Oracle E-Business Suite, Microsoft Dynamics 365, Prophet 21, and IFS, focusing on ensuring these platforms meet compliance requirements for data integrity, security, and operational efficiency. Our validation services include detailed risk assessments, functional testing, user acceptance testing (UAT), and comprehensive documentation to satisfy regulatory audits. We address key areas like user access control, electronic records, and data traceability, ensuring your ERP system adheres to industry standards such as FDA 21 CFR Part 11 and EU Annex 11. By providing a meticulous approach to CSV, we help you achieve a validated state for your ERP, minimizing compliance risks and enhancing process reliability.
This service is designed to streamline implementation, reduce system downtime, and enhance overall compliance, making it an essential part of your quality assurance strategy. With Cerduro’s expertise, you can ensure your ERP system is compliant, reliable, and fully optimized for your business needs.
Laboratory Information Management Systems (LIMS)
We provide specialized validation services for Laboratory Information Management Systems (LIMS) such as LabWare, STARLIMS, and LabVantage to ensure compliance with regulatory requirements like FDA 21 CFR Part 11 and GxP guidelines. Our comprehensive CSV process starts with a detailed risk assessment to identify critical areas that require validation, focusing on data integrity, user access controls, and system functionalities. We perform extensive functional testing and user acceptance testing (UAT) to verify that the LIMS software operates as intended across all defined processes. This includes validating key modules such as sample tracking, data collection, and electronic records management to ensure accurate and reliable laboratory results.
We also emphasize data integrity checks, ensuring that all data generated, stored, and reported by the LIMS is accurate, complete, and consistent. Our validation documentation includes protocols, test scripts, and traceability matrices, providing a clear audit trail for regulatory inspections. By adhering to industry best practices, we help you maintain a robust and compliant LIMS environment, reducing the risk of data discrepancies and regulatory findings. With Cerduro’s expert validation services, you can confidently leverage your LIMS to improve laboratory efficiency, streamline compliance, and enhance overall data quality.