ObseviaeQMS

System of record

Obsevia eQMS

Controlled documents, Part 11 signatures, training, quality events, and tech-file EvidenceLinks — with intelligence that proposes, never silently mutates.

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C-05–C-11

Compliance core

SSO ≠ e-sign. Immutable audit trail. Full export freedom.

C-16

EvidenceLinks

One validation linked across products, TF, and DMR views.

C-20

HITL intelligence

Gap analysis and RI proposals require human disposition.