GMP-PAT DIGITAL VALIDATION PLATFORM
A platform supporting real-time PAT operation, model lifecycle management, validation documentation, and regulatory readiness for pharmaceutical and biopharmaceutical GMP manufacturing.
IMPLEMENT. VALIDATE. OPERATE. DEFEND.
ONE PLATFORM STRUCTURE
When instrument data, analytical models, production runtime, and operational records remain disconnected, traceability and validation burdens increase. rAI provides a structure that connects the role and evidence of each stage.
Real-time PAT Runtime
Supports the acquisition and storage of Raman, NIR, and other spectral instrument data in a runtime environment, together with the execution of reviewed prediction models and management of operational records.
Modeling & Model Lifecycle Platform
Supports lifecycle governance connecting model artifacts from SIMCA or another analytical engine with candidate intake, independent review, approved versions, and deployment evidence.
Enterprise Monitoring Platform
Supports centralized review of key operating status and model information generated across connected rAI-GO environments.
The final integration scope is defined according to the instruments, interfaces, product edition, and project configuration.
ACTUAL PRODUCT INTERFACES
Actual product interfaces previously published on the corporate website illustrate how runtime operation connects with model lifecycle management. Core functions remain accessible while key evidence is retained in a reviewable structure.
Real-time PAT Runtime
Review real-time spectra, prediction values, instrument status, and execution records in one interface while tracing the information needed for operational decisions.
Modeling & Model Lifecycle
Model calculation is performed in a project-approved analytical engine such as SIMCA; rAI-Q supports structuring lifecycle information from candidate intake through independent review, approved versions, and deployment evidence.
Supplied representative views illustrate how data review, model-development evidence, and results review can be connected.
These are supplied conceptual and comparison examples. Current commercial scope is confirmed by edition, analytical engine, and project agreement.
The images are supplied representative or reference materials. Actual functions, terminology, modeling engine, approval workflow, and layout are confirmed by product version, edition, license, and project scope.
PART 11 COMPLIANCE MODULE
Supports electronic records, electronic signatures, audit trails, user access management, approval workflows, and change history with consideration for FDA 21 CFR Part 11 and EU GMP Annex 11 requirements.
Management of reviewable electronic records
Electronic signature workflows configured to the project scope
Traceable records of defined system events
Role-based access control and segregation-of-duties principles
Review and approval stages with change history
Risk-based CSV and validation deliverable support
VALIDATION & LIFECYCLE SERVICES
Services are configured in stages, from documentation through GMP-PAT validation and full implementation, according to the adoption scope and regulatory requirements.
Documentation
Establishes a connected document structure covering planning, requirements, risk assessment, testing, traceability, and summary reporting.
Define scopeValidation
Supports definition of the validation scope and execution evidence appropriate to the intended use of the system and analytical models.
Define scopeImplementation
Connects implementation, integration, validation, training, and operational readiness through a phased adoption plan.
Define scopeApplies to implementation, configuration, documentation, and test-support activities defined in the approved SOW and project plan.
Customer infrastructure approval, SOP approval, PQ, final validation acceptance, and manufacturing or quality decisions remain customer responsibilities.
Basic maintenance is included for the first year after initial implementation. Annual maintenance is contracted separately from year two.
rAI-SW provides functions and validation-support structures that consider relevant GMP and electronic-record requirements. Final suitability depends on the customer's intended use, approved procedures, and QMS.
ABOUT rAI-SW
rAI-SW is a specialized platform company connecting PAT data with governed manufacturing operation, model lifecycle management, validation evidence, and audit readiness for pharmaceutical and biopharmaceutical organizations.
BUSINESS INQUIRY
We review your current instrument environment, model operating approach, validation scope, and implementation timeline.
Open Business Inquiry Paid PoC pilot and implementation scope are defined through separate consultation.