Welcome to EngCor Readiness Quiz

Achieving operational readiness using the ORAT model ensures that all systems, processes, personnel, and technologies are optimized to meet production goals while adhering to project deliverables and regulatory requirements.

Some of the key aspects include:

· Facility Readiness – including completing facility design and construction, facility qualification, establishing cleaning regimes, EM mapping and PQ, equipment commissioning and qualification

· Process Readiness – including process validation, establishing SOPs and batch records 

· Personnel Readiness – including training, gowning and hygiene practises and defining roles and responsibilities between current and future state

· Technology / System Readiness – including system validation, data collection, establishing automation / monitoring systems and assessing data integrity

· Regulatory Readiness – including establishing a robust quality management system, ensuring compliance with regulations, mock audits and establishing a licencing plan

· Supply Chain & Logistics – including temperature mapping of storage, transport validation, establishing raw material and product testing, validation suppliers and materials

· Contingency Planning & Business Continuity – including establishing crisis management, contingency protocols and alarm management processes