Computer System Validation
Validation by 6M
At 6M Consulting, we recognize that validation is at the heart of every compliant Life Sciences system. Our team delivers validation strategies that meet global regulatory standards while optimizing efficiency and traceability. Whether implementing new systems or upgrading existing ones, we ensure your technology meets GxP, FDA, EMA, and other industry requirements.
Our expertise includes:
- CSV (Computer System Validation): Full lifecycle validation for GxP systems.
- Risk-Based Validation: Focused, efficient validation aligned with ISPE GAMP 5 guidance.
- Validation Documentation: SOPs, IQ/OQ/PQ, and validation summary reports.
- Audit Readiness: Proactive preparation for regulatory and client audits.
Why Choose 6M?
- Compliance Experts: Decades of experience in validated environments.
- Efficient Documentation: Streamlined, traceable validation packages.
- Cross-System Coverage: Validation support for cloud, SaaS, and on-premise solutions.
- Sustained Quality: Ongoing monitoring and revalidation support for system changes.
