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Procedure 'XPR-100 Document Control' defines how to mark documents as obsolete, covering ISO 13485:2016 clause 4.2.4.
Retention periods for quality records are fully defined in 'XPR-101 Record Control'.
Retention period for obsolete documents is not defined in 'XPR-100 Document Control', as required by clause 4.2.4.
LumiDocs pinpoints every non‑compliance and links it straight to its exact clause and source document. Close gaps faster and eliminate blind spots to stay audit-ready and go to market with the speed patients and potential users deserve.
LumiDocs analyzes your documents for consistency, clarity, and compliance. Once the analysis is complete, it provides clear, actionable mitigations that non‑regulatory teams can execute and experts can use to supercharge their productivity.
Section 'Identification' in 'SOP‑411 Record Control' notes 'In the event of a revision greater than 1, changes must be highlighted in the Change History.' This phrasing might imply it is the only method for tracking revisions, potentially overshadowing the primary electronic audit trail described in 'QI‑22 Audit Log'. While QI‑22 defines the detailed compliance requirements, the statement in SOP-411 can introduce slight ambiguity.
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