Overview
Document and Master File Management in ComplianceQuest brings all product design evidence under control and in context. Controlled Documents manage the full document lifecycle creation, review/approval, training, access, distribution, periodic review, revision, and retirement so quality records stay compliant, current, and audit-ready across the organization.
Master Files (DHF and DMR) give design teams a curated “source of truth” for historical and released records tied directly to each Design File, providing end-to-end traceability of what was designed, how it was built, and the procedures/specifications used in production.
Master Files are referenced to the Design File record. Both Design History Files (DHF) and Device Master Record (DMR) are automatically created. They are associated with CQ records and are managed by the CQ Administrator. See your CQ Administrator if no Design History Files (DHF) or Device Master Records (DMR) are listed under the Design File record. Also, note that after the documents are linked to the Design File record, the User must refresh the page to see the documents in the DHF and DMR.
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