Regulated manufacturing
Start with applicability, not a compliance label.
Bring the obligations that apply to your organization into the evaluation early. Identify the data, contracts, responsible professionals, and evidence needed for the exact proposed environment. A product page cannot establish certification, authorization, or customer compliance.
Define the boundary
Identify the legal entities, facilities, systems, users, data, jurisdictions, contracts, standards, network zones, model providers, subprocessors, and responsible owners in scope.
Map requirements to responsibility
For each applicable requirement, identify Cortrova behavior, customer procedure, external control, evidence, test, exception, and accountable owner. A feature description is not control evidence.
Validate before production
Test access, approval, segregation, records, retention, export, deletion, audit retrieval, recovery, incident handling, AI failure and disablement, and any regulated electronic signature or data-boundary requirement with representative scenarios.