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About Ploutis

PLOUTIS | ENGINEERING & LEADERSHIP FOR LIFE SCIENCES Bringing a facility from initiation to final handover shouldn't be a gamble. We provide the technical leadership and risk-based engineering required to navigate the complex lifecycle of Life Science projects with precision. ENGINEERING EXCELLENCE, DELIVERED In an industry where compliance is non-negotiable and downtime is costly, Ploutis bridges the gap between high-level strategy and technical execution. Grounded in the GAMP 5 V-Model and Risk-Based Quality Management, we ensure your facility expansions and system deployments are site-compliant and audit-ready. Our deep technical expertise spans the entire project roadmap: 🔹 PROJECT MANAGEMENT: End-to-end oversight of facility expansions and system deployments, aligning milestones with technical requirements. 🔹 IT/OT, AUTOMATION & MES: Platform-agnostic solutions for complex manufacturing, from infrastructure virtualization to control system integration. Auditing and implementation against ALCOA+ principles and 21 CFR Part 11. 🔹 CQV (Commissioning, Qualification & Validation): Site-compliant generation and execution of FAT, SAT, IQ, OQ, PQ for equipment, utilities, and computerized systems. SCALABLE SUPPORT & FLEXIBLE MODELS We provide the scale your project requires—from individual Subject Matter Experts (SMEs) to fully dedicated, multi-disciplinary project teams—via three engagement models: 1. TIME & MATERIAL (T&M): Maximum adaptability for discovery and evolving scopes. 2. FIXED BID: Total cost predictability and defined deliverables. 3. HYBRID: Integrates T&M for initial strategy with Fixed Bid for final execution—ideal for large-scale facility expansions. READY TO SCALE YOUR NEXT PROJECT? Follow us for insights on GAMP 5, CQV best practices, and Life Science engineering, or 👇 visit our website to discuss your requirements.