Device History Record ‘Oversights’ A Clear Path To Quality Troubles, FDA Says
• By Shawn M. Schmitt
Manufacturers are overlooking various key elements that should be included in device history records, including up-to-date labels, dates of product manufacture and missing signatures on documents, FDA says. Because DHRs touch virtually every part of a firm’s quality system, a flawed DHR can prompt agency investigators to dig deeper during inspections. Further, DHRs with absent signatures, test records or traceability records might cause investigators to doubt the validity of a manufacturer’s quality system. Experts also urge companies to make sure that device history records link to device master records, and they remind firms that DHRs are also tethered to production and process control requirements. Some manufacturers are in the beginning stages of implementing electronic device history records in an effort to curb mistakes and unnecessary costs.
Deficient device history records are a tell-tale sign for FDA that a manufacturer might not have adequate control over its quality system, according to an agency official and industry quality experts.
Device history records (DHRs) touch virtually every part of a firm’s quality system, so a flawed DHR can prompt agency investigators to dig deeper during inspections.
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