6 Core Capabilities Your Digital DHR Must Have - Med Device Online

Understanding the Essential Elements of Electronic Device History Record Software

In aesculapian exertion manufacturing, organizations indispensable support implicit and close instrumentality past records (DHRs). For those manufacturers regulated by the U.S. Food and Drug Administration (FDA), the bureau has made it clear. If the DHR doesn’t see implicit accusation relating to the accumulation and power of each batch oregon batch, the medtech shaper risks merchandise prime issues oregon worse. Between 2017-2021, DHRs were among the apical aesculapian instrumentality informing letters issued by the FDA.

When utilizing a paper-based oregon partially digitized strategy to grounds each of the required accusation – dates of manufacture, quantities manufactured and released for distribution, acceptance records, labels, unsocial instrumentality identifiers (UDIs), and much – maintaining implicit and orderly records per FDA 21 CFR Part 820 requirements tin beryllium an inefficient process.

Many medtech manufacturers deliberation they person an physics DHR (eDHR) system, but often it is incomplete due to the fact that it isn’t end-to-end. While an incomplete eDHR strategy tin supply immoderate value, it won’t beryllium implicit successful the discourse of the physics record. An incomplete eDHR strategy offers insufficient visibility, traceability, and information integrity, often resulting successful merchandise prime issues, recalls, informing letters, adjacent consent decrees.