Empower your pharmaceutical operations with absolute regulatory confidence. OYTEC transforms your validation strategy into a competitive advantage, delivering audit-ready GxP systems. By integrating GAMP 5 excellence into your lifecycle, we ensure your technology drives production forward without compliance friction. Secure your Go-Live with precision-engineered documentation and expert partnership for any global platform.
We define the roadmap for compliance success. From the Validation Master Plan (VMP) to detailed risk assessments, we establish a clear, structured framework that aligns project stakeholders and sets the standard for quality deliverables from day one.
Optimise testing efforts with precision. Using GAMP® 5 risk assessment methodologies (FMEA), we identify critical process flows, configurations, integrations and developements. This focuses verification on high-risk areas, ensuring patient safety without over-testing.
Safeguarding your digital records. We execute specific protocols to verify ALCOA+ compliance, ensuring your system’s security, audit trails, and electronic signatures meet FDA 21 CFR Part 11 and EU Annex 11 requirements for total data reliability.
Quality integrated at every step. We manage the entire V-model lifecycle (URS, FS, DS, IQ, OQ, PQ) ensuring traceability between requirements and tests. Our approach guarantees that quality is built into the design, preventing costly errors during final qualification.
Safeguarding your digital records. We execute specific protocols to verify ALCOA+ compliance, ensuring your system’s security, audit trails, and electronic signatures meet FDA 21 CFR Part 11 and EU Annex 11 requirements for total data reliability.