VALIDATION & LIFECYCLE SERVICES
Documentation, GMP-PAT Validation, and Full Implementation are configured as phased services according to adoption scope and regulatory needs.
Builds a connected document system from planning and requirements through risk assessment, testing, traceability, and summary reporting.
Supports validation scope and execution evidence appropriate to the intended use of the system and analytical models.
Connects configuration, integration, validation, training, and operational readiness through a phased adoption plan.
CONTROLLED BOUNDARIES
Deliverables, tests, schedule, and roles follow the approved SOW and project plan.
rAI-SW supports documentation, configuration, and testing; the customer owns intended use, SOPs, infrastructure, PQ, and final approval.
Manufacturing and quality decisions, final regulatory response, and validation acceptance remain customer responsibilities.
Basic maintenance is included for the first year; annual maintenance is contracted separately from year two.
BUSINESS INQUIRY
We define the implementation scope around your instrument environment, intended use, model operating approach, validation needs, and timeline.
Business Inquiry Paid PoC and implementation scope are confirmed through separate consultation.