...connect contintents®
Ensuring Compliance, Quality, and Reliability
Regulated industries face the critical challenge of ensuring their systems comply with stringent international standards like GAMP 5, FDA 21 CFR Part 11, and EU Annex 11. Computer System Validation (CSV) is essential to achieving this compliance while maintaining system efficiency and reliability. NEPTUNE specializes in providing tailored CSV solutions that address these challenges, ensuring your systems are both compliant and optimized for performance.
Our approach is to build a lasting partnership with you, your team, and your systems. This ensures we’re always prepared to support you when you need us most. We work alongside your team to provide expert guidance and services, including:
Validation Planning
Developing comprehensive validation plans that outline the scope, approach, and deliverables for your projects.
Risk Assessment
Identifying and mitigating risks to ensure the reliability and safety of your systems.
Requirements Specification
Drafting clear and concise URS (User Requirements Specifications) and FS (Functional Specifications) that align with your business needs.
Testing and Qualification
Conducting IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) to verify and validate system functionality.
Documentation
Delivering all required documentation, including validation protocols, traceability matrices, test scripts, deviation reports, and final validation reports, to meet audit standards.
