A
licenseNot graded
qualityB
maintenanceEnables AI agents to discover, risk-assess, request, and track actions on validated BioPharma systems (LIMS, MES, QMS, ELN) without bypassing the validated state, routing each request through GAMP 5 risk classification, ALCOA+ checks, approval workflows, and 21 CFR Part 11 e-signatures. Agents can also retrieve signed, verifiable execution records and audit evidence for the actions they perform.
Apache 2.0