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I am looking for more clarification on what records to retain to meet the MDD 6.1 requirement. We don't build an active implantable device - so I am using 5 yrs after the last product has been manufactured as the retention period.
Therefore, some types of records are very clearly to be retained for this period - DHR, DMR, Risk files, etc becuase they tie directly to the product . But others such as CAPA, Mgmt review & Internal audits (records of the quality system) don't seem to be tied to the "last product manufactured" time frame.
So my question is: What records are covered by the "5 yrs after last product manufactured" and which are not? Especially given MDD 6.1 also refers 3.1 -indent 4 Quality management system.
Can I get away with 5 year retention from date of issue for CAPA, mgmt review, etc?
confused - thansk for advice!
Therefore, some types of records are very clearly to be retained for this period - DHR, DMR, Risk files, etc becuase they tie directly to the product . But others such as CAPA, Mgmt review & Internal audits (records of the quality system) don't seem to be tied to the "last product manufactured" time frame.
So my question is: What records are covered by the "5 yrs after last product manufactured" and which are not? Especially given MDD 6.1 also refers 3.1 -indent 4 Quality management system.
Can I get away with 5 year retention from date of issue for CAPA, mgmt review, etc?
confused - thansk for advice!