A Device History Record (DHR) is the complete, audit-proof documentation of the manufacturing of a medical device or batch. It proves that a product was built exactly according to approved specifications, processes and quality requirements. In medical device manufacturing, the DHR is a regulatory requirement under FDA 21 CFR Part 820 and a mandatory part of product release.
The DHR contains production data, inspection results, material usage, process parameters, approvals and deviations, creating a full product history.
The Device History Record ensures that every released product is traceable, compliant and reproducible. During audits, complaints or recalls, the DHR is the primary evidence of proper manufacturing. Without a complete DHR, a medical device cannot legally be released to the market.
A DHR includes serial or batch numbers, materials and bills of material, machine and process parameters, inspection results, deviations and corrective actions, and final quality approval. All data must be time-stamped, immutable and clearly linked to the specific product.
A modern MES automatically generates the DHR from production and quality data. Machine values, inspection results, operator actions and workflow decisions are captured in real time and assigned to the product or batch. This creates an electronic DHR (eDHR) that is complete, secure and audit-ready.
A digital DHR reduces manual documentation, prevents errors and speeds up product release. It also increases audit readiness and enables fast root-cause analysis when quality issues occur.