CSV for GxP Systems - EU-GMP & FDA 21 CFR Part 11 compliance

CSV for GxP Systems - EU-GMP & FDA 21 CFR Part 11 compliance drevet af OYTEC

Hos OYTEC sætter vi erfaringen og viden om vores menneskelige kapital til kundeservice og tilbyder den bedste løsning på deres behov i tråd med forretningsmålene: Ønsket om at etablere et tæt og varigt partnerforhold med vores kunder baseret på gensidig tillid, fælles arbejde og fremragende service. Under hensyntagen til menneskelig kapital som et differentielt element. Systemer vil blive designet og udviklet til at hjælpe mennesker og tilskynde til deres kreativitet. Tilbyder løsninger på forudsætning af specialisering som grundlag af vores erfaring og viden. Hovedsageligt i GMP & FDA Compliance-miljøer.

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Hvorfor Risk-based CSV services for GxP computerized systems?

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.

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Fordele

Inspection-ready evidence:
Audit-ready validation deliverables aligned to EU-GMP and FDA 21 CFR Part 11, structured for fast review and clear traceability from requirements to testing.
Faster & safer go-live:
Risk-based CSV (GAMP® 5 aligned) focuses effort where it matters most, reducing rework and enabling confident release to production without delaying the project.
Applicable to any GxP system:
Proven methodology adaptable to any computerized system (manufacturing, quality, lab, or enterprise), including Siemens Opcenter Execution Pharma and integrated landscapes.
Quality as a Business Driver:
Validation embedded into lifecycle governance (change, periodic review, incident handling) to maintain a controlled state and prevent compliance drift over time, turning quality into a tool for continuous process improvement.
Complete Data Integrity.
Our validation protocols rigorously verify ALCOA+ principles throughout your system’s lifecycle. Assuring integrity, safety and trceability of all GxP data.

Udvalgte funktioner

Strategic Validation Planning

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.

Scientists in protective gear in laboratory

Risk-Based Verification

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.

Data Integrity Assurance

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.

Scientist in clean room operating equipment

Lifecycle Quality Management

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.